Cardiac Surgical ProceduresNCT05966337
Effects of Non-invasive Ventilation in Patients Undergoing Heart Surgery
A study testing CPAP and BIPAP in people with Cardiac Surgical Procedures and Continuous Positive Airway Pressure, run by Universidade Federal do Rio Grande do Norte at 1 site in Brazil.
Trial summary
The goal of this randomized controlled clinical trial is to compare effects of non-invasive ventilation with different modalities (notably CPAP and BIPAP) in patients undergoing heart surgery. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cardiac Surgical Procedures, Continuous Positive Airway Pressure, BIPAP Biphasic Intermittent Positive Airway Pressure
- What is being tested?
- CPAP and BIPAP
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 62 participants
- Where
- 1 siteBrazil
- Study dates
- Aug 2023to Feb 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- aged over 18 years
- stable from the hemodynamic point of view (controlled blood pressure, normocardic
- conscious and oriented and cooperative4
- without medical restrictions for carrying out the treatment
Who cannot join
- Presence of uncontrolled cardiac arrhythmias (Examples: total atrioventricular block, type 2 2nd degree atrioventricular block, atrial fibrillation, sustained ventricular tachycardia)
- previous neuromuscular disease
- labyrinthitis and some orthopedic/skeletal muscle restriction.
- Unstable angina, stage 3 SAH (SBP ≥ 180 mmHg and/or DBP ≥ 110 mmHg at rest), HR > 120 bpm at rest, systemic arterial hypotension with clinical repercussions (SBP ≤ 90 mmHg and/or DBP ≤ 60 mmHg),(),
- aortic dissection.
Trial locations and contacts
1 site in 1 country.
Brazil1 site, 1 recruiting
- Recruiting
Hospital João XXIII
Campina Grande, Paraíba, 58108-620
Eder R Araújo, doctoral, 83988998813, eder.rodrigues.araujo@gmail.com
About this study
Official title: Effects of Non-invasive Ventilation With Different Modalities in Patients Undergoing Heart Surgery: a Randomized Controlled Clinical Trial
The goal of this randomized controlled clinical trial is to compare effects of non-invasive ventilation with different modalities (notably CPAP and BIPAP) in patients undergoing heart surgery. The main question[s] it aims to answer are:
- Which NIV ventilation mode is most effective in cardiac surgery patients?
- Is there a big difference between conventional physiotherapy treatment and the use of NIV in these patients? Participants will be submited in the intervention will initially take place in the specific ward that receives patients in the postoperative period of cardiac surgery. Participants will be recruited after the patient is hospitalized the day before the surgery, during which time he will undergo a preoperative evaluation based on the study criteria. On that first day, the evaluation will consist of anamnesis and physical examination, focusing on the history of cardiac disorders, followed by measurements inherent to the protocol. Manovacuometry, chest X-ray, quality of life questionnaire, walk test and spirometry. The evaluation can be carried out in two stages, if there are other demands for the patient during his hospitalization.
Researchers will compare three groups: 1 - cpap group - CPAP + usual physical therapy care, 2 - Bipap group - BIPAP + usual physical therapy care and 3 - Control - usual physical therapy care), in the 1:1 allocation ratio and superiority. to see if the effects of non-invasive ventilation with different modalities in patients undergoing cardiac surgery demonstrates some superior way in clinical practice. The observed outcomes will be: evaluation between NIV modalities, spirometry, lung capacity and vital signs. Secondary outcomes included are degree of satisfaction with the global perception of change scale, and MIF - functional independence measure and blood gas parameters.
Read the detailed description
The study protocol was conducted following the Standard Protocol Items: Recommendations for Interventional Trials (SPIRIT) checklist. This is a single-center, randomized, controlled, double-blind clinical trial, in which participants and outcome evaluators were blinded. The study will be submitted to the ethics committee of the State University of Paraíba (UEPB) and carried out in accordance with the Declaration of Helsinki. All participants must provide written informed consent prior to participation, and the study will be registered on the CLINICALTRIALS platform. All participants must provide written informed consent prior to participation. Participants will be divided into three groups (cpap group - CPAP + usual physical therapy care, bipap group - BIPAP + usual physical therapy care and control group - usual physical therapy care), in a 1:1 allocation ratio and superiority.
The project will be carried out at Hospital João XXIII in the city of Campina Grande, Paraíba, Brazil. It is a private hospital affiliated with the SUS network, a reference in cardiology and especially in cardiac surgery for a good part of the state and surrounding states. It presents in its weekly program an average of 8 cardiac surgeries. The evaluation and intervention will take place in the ICU and ward.
Post-randomization exclusion criteria: In case of undertaking any treatment in the hospital environment that contraindicates participation in the study (pacemaker implantation, pneumothorax requiring chest drainage, for example), death or other decompensations not related to the research and return to the ICU .
Criteria for non-adherence to the intervention: Patient who does not perform 3 or more sessions in a row, who withdrew from participating in the study and who has some cardiac arrhythmia (atrial fibrillation, bradycardia) for two sessions even after medication used to contain and pause for rest.
Non-retention criteria: Patient who does not perform one of the reassessments. Professional eligibility criteria: Hospital staff physiotherapists and physiotherapy students with previous training in the research protocol.
Procedures for Conducting the Research The purpose of this project is to carry out a randomized clinical trial and verify the effectiveness of NIV compared to conventional physiotherapy in terms of the rate of pulmonary complications in patients undergoing cardiac surgery in a chosen hospital in the city of Campina Grande, Paraíba.
Thus, there will be a partnership with the Núcleo de Tecnologia Estratégicas em Saúde (NUTES) of the State University of Paraíba (UEPB) through the biomedical computing laboratory for the development of research aimed at the remote monitoring of health data through smartwatches and other devices that comply with international standardization norms for interoperability between health technologies. NUTES already collaborates with UFRN in several scientific and technological cooperation researches, so that the co-supervisor of the project, Prof Paulo Eduardo Barbosa made the strategic partnership possible, according to the attached document. NUTES' participation in this project will take place through the feasibility of remote monitoring technology via Smartwatch and the introduction of data collected on a specific platform.
For a better understanding and operationalization of the research, it was divided into 5 phases.
- st Phase: Documentary Survey and Consent At first, there was initial contact with the aforementioned hospital institution for consent to the research. At the same time, a documentary and systematic study on the subject was instituted, in order to base the research and identify possible indices and/or parameters that would add to the research in order to make it viable and absolutely realistic.
- nd Phase: Search and profile of NIV and Smartwatch devices Non-invasive ventilation (NIV) will be performed both in the ICU environment and in the ward for the intervention group. A BIPAP will be made available and a CPAP for the respective groups. The interface chosen will be the nasal mask, aiming at greater patient comfort. Thus, we will choose properly calibrated NIV devices on the market that provide better adaptation to patients. All the main information about users can be entered into the platform, such as gender, age, other illnesses, use of medication, and some special situations that can be verified in practice, in addition to information that may come from the monitoring carried out by the smartwatch on patients in the moment of data collection during NIV application. Thus, data from the patient's medical record will also be used. A large volume of data can be entered into the platform and used to generate a profile of cardiac patients selected for the survey. The smartwatch used will be from the Garmin brand and available for capturing Sao2 and VO2. The main functionalities of the Dashboard comprise the visualization of the data of the surgical patients submitted to NIV in the initial screen in a computer, being able to apply filters according to the interest of the researcher.
- rd Phase: Technical Study and applied tests This project is interested in three major aspects: the use of non-invasive ventilation in heart patients undergoing cardiac surgery; the automation of data collection using the smartwatch, making it practical, simple, accessible technology in order to become a predictor of safe discharge for these patients; finally, a survey of a large volume of data (verified in the analysis profile of the patients) that can generate subsidies for carrying out research and contribute to the increase of studies in the area of cardiopulmonary physiotherapy on technological bases.
- th Phase: Pilot Study - Practice After that, the surgeries will begin and the collection will consist of 6 patients, thus defining the beginning of the pilot study. Upon being notified of the weekly surgical schedule, the researcher in charge will randomize the patients. This register will contain the complete identification of the patient, type of surgery to which he will be submitted and the pathology. Thus, as the patients leave the surgical center and go to the ICU, they will follow the protocol so that the treatment due to the group to which the patient is allocated on the day after the surgery begins. It should be noted that the pilot study should only be started after approval by CEP. After completion of the pilot study, there will be an evaluation of the entire protocol so that possible flaws can be corrected before definitive collection.
- th Phase: Data collection It will consist of collecting data from patients in the post-randomization intervention and allocation of patients to a group, following the procedures of the protocol.
- Conditions
- Cardiac Surgical Procedures, Continuous Positive Airway Pressure, BIPAP Biphasic Intermittent Positive Airway Pressure
- Being tested
- CPAP, BIPAP, Usual care in phisicaltherapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CPAPProcedure or surgery
Use of non-invasive ventilation in patients in group 2 with CPAP.
BIPAPProcedure or surgery
Use of non-invasive ventilation in patients in group 3 with BIPAP.
Usual care in phisicaltherapyProcedure or surgery
Patients undergoing usual physiotherapy treatment, consisting of a kinesiotherapy protocol
| Study group | Role | What they receive |
|---|---|---|
| Control group 1 (usual care) | Active comparator | Patients undergo physiotherapy treatment twice daily, transitioning from the ICU to the ward. The treatment plan spans several days, starting on the first postoperative day after ICU discharge. In the ICU, Day 1 includes diaphragmatic breathing exercises, coughing stimulus, upper limb exercises (shoulder flexion/extension, abduction), and lower limb exercises (thigh flexion, dorsiflexion/plantarflexion). Day 2 involves diaphragmatic breathing, coughing stimulus, upper limb exercises, lower limb exercises, cycling for 3 minutes, and respiratory device exercises. Upon moving to the ward on Day 3, patients perform diaphragmatic breathing, coughing stimulus, upper limb exercises, lower limb exercises, and a 5-minute walk. Day 4 focuses on diaphragmatic breathing, coughing stimulus, and a 10-minute walk. Finally, on Day 5, patients engage in diaphragmatic breathing, coughing stimulus, and a 15-minute walk. Receives: Procedure: Usual care in phisicaltherapy |
| Intervention group 2 (CPAP) | Experimental | They will be submitted to the same care as the control group, adding NIV with nasal CPAP 10cmH2O for 1 hour using device and brand approved by ANVISA, during the 5 days of hospitalization, both in the ICU and in the ward. The frequency of the sessions will be two (2) per day, in the morning and in the afternoon. Flexibility of time for carrying out the procedure is also planned, since in a hospital environment the patient can often undergo exams, other behaviors that may make it difficult to apply the protocol at the initially scheduled time. After the fifth day, the patient will be reassessed with the same instruments reported. Receives: Procedure: CPAP; Procedure: Usual care in phisicaltherapy |
| Intervention group 2 (BIPAP): | Experimental | They will undergo the same care as the control group, adding NIV with nasal BIPAP with IPAP of 13cmH2O and EPAP 8 cmH2O for 1 hour, using equipment and brand approved by ANVISA, during the 5 days of hospitalization, both in the ICU and in the ward . The frequency of the sessions will be two (2) per day, in the morning and in the afternoon. Flexibility of time for carrying out the procedure is also planned, since in a hospital environment the patient can often undergo exams, other behaviors that may make it difficult to apply the protocol at the initially scheduled time. After the fifth day, the patient will be reassessed with the same instruments reported. Receives: Procedure: BIPAP; Procedure: Usual care in phisicaltherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pulmonary function
All participants will undergo an evaluation by a CONTEC model spirometer (SPB80b, CHINA) to verify lung volumes and capacities. At least three tests will be performed, with a variation of less than 5% and the highest value obtained in one of the tests will be compared with the predicted values of pulmonary function parameters for the Brazilian population. FEV1 and FVC will be assessed. The predicted values will be calculated using the reference values (PEREIRA et al., 2007).
Measured: Day 1 and day 5
Length of hospital stay
Absolute number of days of hospitalization up to 2 weeks after the date of randomization.
Measured: The length of hospital stay will be assessed and reported as the number of days from admission to discharge, measured up to 2 weeks after the date of randomization.
Presence of lung complications
assessment of the occurrence or absence of any complications related to the lungs during the hospitalization period.cause, whichever occurs first, measured up to 2 weeks
Measured: From the date of randomization to the date of the first documented progression or the date of death from any cause, whichever occurs first, measured up to 2 weeks after the date of hospital discharge.
Secondary outcomes (9)
Score of the Minnesota Living with Heart Failure Questionnaire (MLHFQ) in Portuguese version
The Portuguese version of the MLHFQ will be used to assess the patient's quality of life. The questionnaire provides a final score as a metric, and the change in score over the treatment period will be evaluated. The MLHFQ score is a measure of health-related quality of life in patients with heart failure. The higher the score, the greater the negative impact of heart failure on the patient's quality of life. A score of 0 indicates that the patient has no limitations or problems related to heart failure, while a score of 105 indicates a maximum limitation or problem in all areas assessed by the questionnaire.
Measured: Day 1 and Day 5
Funcional capacity
The TUG test will be performed to assess functional capacity. The patient will start from a sitting position, walk quickly for 3 meters, turn 180 degrees, and return to the chair. The time taken, measured from standing up to completely leaning the trunk against the chair, will be recorded. Time values below 10 seconds indicate maximum functionality, 10 to 19 seconds indicate functional independence, 20 seconds and above indicate some functional limitation, and 30 seconds and above indicate significant functional limitation.
Measured: Day 1 and Day 5
The global perception of change scale
The GPCS is a self-report tool that assesses an individual's perception of change in a specific domain. It uses Likert-scale items ranging from "a very great deal worse/less" to "a very great deal better/more" to capture subjective information about perceived change.
Measured: Day 1 and Day 5
The functional independence measure (MIF)
The MIF questionnaire will be administered preoperatively and on the sixth day to assess functional independence.
Measured: Day 1 and Day 5
pO2 (partial pressure of oxygen)
Partial pressure of oxygen (PO2) is a key physiological parameter that measures the pressure exerted solely by oxygen molecules in a mixture of gases, such as air or blood. It is an important indicator of the oxygen-carrying capacity and oxygen exchange efficiency in the respiratory system (ROCA et al. 2020). PO2 will be measured in millimeters of mercury (mmHg) (BAI, et al. 2020)
Measured: Days 1 and 2.
pCO2 (partial pressure of carbon dioxide)
Partial pressure of carbon dioxide (pCO2) is a fundamental physiological parameter that measures the pressure exerted solely by carbon dioxide molecules in a mixture of gases, such as air or blood. It plays a crucial role in the regulation of acid-base balance and respiratory function.
The unit of measurement for pCO2 will be expressed in millimeters of mercury (mmHg).(RODRIGUEZ, 2006)
Measured: Days 1 and 2.
HCO3 (bicarbonate)
Bicarbonate (HCO3) is an important physiological parameter that measures the concentration of bicarbonate ions in the blood. It is a vital component of the body's acid-base balance and plays a crucial role in maintaining the pH of the blood within a normal range.
The unit of measurement for bicarbonate will be expressed in milliequivalents per liter (mEq/L) (CHUA, 2011).
Measured: Days 1 and 2.
Arterial Oxygen Saturation (SaO2)
Arterial Oxygen Saturation (SaO2) is a critical physiological parameter that measures the percentage of hemoglobin in arterial blood that is bound with oxygen. It reflects the efficiency of oxygen transport from the lungs to the body's tissues.
The unit of measurement for SaO2 is typically expressed as a percentage (%). (CASTRO, et al, 2022)
Measured: Days 1 and 2.
Base Excess (BE)
Base Excess (BE) is a significant physiological parameter that measures the amount of excess or deficit of base (bicarbonate) in the blood, indicating the body's acid-base balance. It quantifies the deviation of the blood's buffering capacity from the normal range, which helps in assessing the metabolic component of acid-base disturbances.
The unit of measurement for Base Excess will be expressed in milliequivalents per liter (mEq/L) (CASTRO, et al, 2022)
Measured: Days 1 and 2.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jul 2023
- Study startAug 2023 (estimated)
- Primary completionFeb 2024 (estimated)
- Study completionFeb 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (15)Papers the sponsor has linked to this study.
- Other trials for Cardiac Surgical ProceduresStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Pacients will be divided into 3 groups (CPAP group - CPAP + usual physical therapy care, BiPAP group - BiPAP + usual physical therapy care, and Control group - usual physical therapy care) in a 1:1 allocation ratio. Control group will receive the usual physiotherapy treatment, as kinesiotherapy protocol. Treatment will be administered twice a day, starting in the ICU and progressing to the ward. In the CPAP group, nasal CPAP at 10cmH2O will be administered for 1 hour, twice a day, using an approved device. In BiPAP group, nasal BiPAP with IPAP of 13cmH2O and EPAP of 8cmH2O will be administered for 1 hour, twice a day, using an approved device. The NIV sessions will be conducted during the 5 days of hospitalization, both in the ICU and the ward. After the fifth day, patients in intervention groups will undergo reassessment using the same assessment instruments as before.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 62 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universidade Federal do Rio Grande do Norte
- Sponsor type
- University, hospital or other
- Collaborators
- Universidade Estadual da Paraiba
- Responsible party
- Principal investigator, Patri-cia Angelica de Miranda Silva Nogueira, Universidade Federal do Rio Grande do Norte
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05966337
- Sponsor's protocol ID
- ERAECR12023
- Other IDs
- 65600722.1.0000.5187
- Status last verified
- Jul 2023
- First submitted
- 8 Jun 2023
- Last updated
- 28 Jul 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Hossen A, Jaju D, Al-Abri M, Al-Sabti H, Mukaddirov M, Hassan M, Al-Hashmi K. Investigation of heart rate variability of patients undergoing coronary artery bypass grafting (CABG). Technol Health Care. 2017;25(2):197-210. doi: 10.3233/THC-161260.
PubMed 28387685Du H, Newton PJ, Salamonson Y, Carrieri-Kohlman VL, Davidson PM. A review of the six-minute walk test: its implication as a self-administered assessment tool. Eur J Cardiovasc Nurs. 2009 Mar;8(1):2-8. doi: 10.1016/j.ejcnurse.2008.07.001. Epub 2008 Aug 9.
PubMed 18694656Shakouri SK, Salekzamani Y, Taghizadieh A, Sabbagh-Jadid H, Soleymani J, Sahebi L, Sahebi R. Effect of respiratory rehabilitation before open cardiac surgery on respiratory function: a randomized clinical trial. J Cardiovasc Thorac Res. 2015;7(1):13-7. doi: 10.15171/jcvtr.2015.03. Epub 2015 Mar 29.
PubMed 25859310Valkenet K, de Heer F, Backx FJ, Trappenburg JC, Hulzebos EH, Kwant S, van Herwerden LA, van de Port IG. Effect of inspiratory muscle training before cardiac surgery in routine care. Phys Ther. 2013 May;93(5):611-9. doi: 10.2522/ptj.20110475. Epub 2013 Jan 3.
PubMed 23288909Dos Santos TD, Pereira SN, Portela LOC, Cardoso DM, Lago PD, Dos Santos Guarda N, Moresco RN, Pereira MB, de Albuquerque IM. Moderate-to-high intensity inspiratory muscle training improves the effects of combined training on exercise capacity in patients after coronary artery bypass graft surgery: A randomized clinical trial. Int J Cardiol. 2019 Mar 15;279:40-46. doi: 10.1016/j.ijcard.2018.12.013. Epub 2018 Dec 10.
PubMed 30581100American Thoracic Society/European Respiratory Society. ATS/ERS Statement on respiratory muscle testing. Am J Respir Crit Care Med. 2002 Aug 15;166(4):518-624. doi: 10.1164/rccm.166.4.518. No abstract available.
PubMed 12186831Carvalho VO, Guimaraes GV, Carrara D, Bacal F, Bocchi EA. Validation of the Portuguese version of the Minnesota Living with Heart Failure Questionnaire. Arq Bras Cardiol. 2009 Jul;93(1):39-44. doi: 10.1590/s0066-782x2009000700008. English, Portuguese, Spanish.
PubMed 198384698. Vieira WO, Barbosa LK, Bezerra AS, et al. Test timed up and go and its correlation with age and functional exercise capacity in asymptomatic women. Fisioterapia em Movimento. 2017;30(3):463-471. doi:10.1590/1980-5918.030.003.AO04.
Bretan O, Silva Junior JE, Ribeiro OR, Corrente JE. Risk of falling among elderly persons living in the community: assessment by the Timed up and go test. Braz J Otorhinolaryngol. 2013 Jan-Feb;79(1):18-21. doi: 10.5935/1808-8694.20130004.
PubMed 23503902Behlouli H, Feldman DE, Ducharme A, Frenette M, Giannetti N, Grondin F, Michel C, Sheppard R, Pilote L. Identifying relative cut-off scores with neural networks for interpretation of the Minnesota Living with Heart Failure questionnaire. Annu Int Conf IEEE Eng Med Biol Soc. 2009;2009:6242-6. doi: 10.1109/IEMBS.2009.5334659.
PubMed 19965089Bai C, Chotirmall SH, Rello J, Alba GA, Ginns LC, Krishnan JA, Rogers R, Bendstrup E, Burgel PR, Chalmers JD, Chua A, Crothers KA, Duggal A, Kim YW, Laffey JG, Luna CM, Niederman MS, Raghu G, Ramirez JA, Riera J, Roca O, Tamae-Kakazu M, Torres A, Watkins RR, Barrecheguren M, Belliato M, Chami HA, Chen R, Cortes-Puentes GA, Delacruz C, Hayes MM, Heunks LMA, Holets SR, Hough CL, Jagpal S, Jeon K, Johkoh T, Lee MM, Liebler J, McElvaney GN, Moskowitz A, Oeckler RA, Ojanguren I, O'Regan A, Pletz MW, Rhee CK, Schultz MJ, Storti E, Strange C, Thomson CC, Torriani FJ, Wang X, Wuyts W, Xu T, Yang D, Zhang Z, Wilson KC. Updated guidance on the management of COVID-19: from an American Thoracic Society/European Respiratory Society coordinated International Task Force (29 July 2020). Eur Respir Rev. 2020 Oct 5;29(157):200287. doi: 10.1183/16000617.0287-2020. Print 2020 Sep 30.
PubMed 33020069Rodriguez P, Lellouche F, Aboab J, Buisson CB, Brochard L. Transcutaneous arterial carbon dioxide pressure monitoring in critically ill adult patients. Intensive Care Med. 2006 Feb;32(2):309-312. doi: 10.1007/s00134-005-0006-4. Epub 2006 Jan 31.
PubMed 16450093Chua HR, Schneider A, Bellomo R. Bicarbonate in diabetic ketoacidosis - a systematic review. Ann Intensive Care. 2011 Jul 6;1(1):23. doi: 10.1186/2110-5820-1-23.
PubMed 21906367Castro D, Zubair M. Arterial Blood Gas Analysis: Fundamentals, Interpretation, and Clinical Utility. 2026 Jul 5. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2026 Jan-. Available from http://www.ncbi.nlm.nih.gov/books/NBK536919/
PubMed 30725604Araujo ER, Bezerra Nogueira ID, E Silva Barbosa PE, Silva Nogueira PAM. Effects of Non-Invasive Ventilation with different modalities in patients undergoing heart surgery: Protocol for a randomized controlled clinical trial. PLoS One. 2024 Jun 18;19(6):e0304569. doi: 10.1371/journal.pone.0304569. eCollection 2024.
PubMed 38889140
Study at a glance
From the registry record, last updated by the sponsor on 28 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Non-invasive Ventilation With Different Modalities in Patients Undergoing Heart Surgery: a Randomized Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT05966337
- Acronym / sponsor ID
- ERAECR12023
- Conditions
- Cardiac Surgical Procedures, Continuous Positive Airway Pressure, BIPAP Biphasic Intermittent Positive Airway Pressure
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 62 participants (estimated)
- Lead sponsor
- Universidade Federal do Rio Grande do NorteUniversity, hospital or other
- Collaborators
- Universidade Estadual da Paraiba
- Study start
- Aug 2023 (estimated)
- Primary completion
- Feb 2024 (estimated)
- Study completion
- Feb 2024 (estimated)
- First posted
- 28 Jul 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this randomized controlled clinical trial is to compare effects of non-invasive ventilation with different modalities (notably CPAP and BIPAP) in patients undergoing heart surgery. The main question[s] it aims to answer are:
- Which NIV ventilation mode is most effective in cardiac surgery patients?
- Is there a big difference between conventional physiotherapy treatment and the use of NIV in these patients? Participants will be submited in the intervention will initially take place in the specific ward that receives patients in the postoperative period of cardiac surgery. Participants will be recruited after the patient is hospitalized the day before the surgery, during which time he will undergo a preoperative evaluation based on the study criteria. On that first day, the evaluation will consist of anamnesis and physical examination, focusing on the history of cardiac disorders, followed by measurements inherent to the protocol. Manovacuometry, chest X-ray, quality of life questionnaire, walk test and spirometry. The evaluation can be carried out in two stages, if there are other demands for the patient during his hospitalization.
Researchers will compare three groups: 1 - cpap group - CPAP + usual physical therapy care, 2 - Bipap group - BIPAP + usual physical therapy care and 3 - Control - usual physical therapy care), in the 1:1 allocation ratio and superiority. to see if the effects of non-invasive ventilation with different modalities in patients undergoing cardiac surgery demonstrates some superior way in clinical practice. The observed outcomes will be: evaluation between NIV modalities, spirometry, lung capacity and vital signs. Secondary outcomes included are degree of satisfaction with the global perception of change scale, and MIF - functional independence measure and blood gas parameters.
Detailed description
The study protocol was conducted following the Standard Protocol Items: Recommendations for Interventional Trials (SPIRIT) checklist. This is a single-center, randomized, controlled, double-blind clinical trial, in which participants and outcome evaluators were blinded. The study will be submitted to the ethics committee of the State University of Paraíba (UEPB) and carried out in accordance with the Declaration of Helsinki. All participants must provide written informed consent prior to participation, and the study will be registered on the CLINICALTRIALS platform. All participants must provide written informed consent prior to participation. Participants will be divided into three groups (cpap group - CPAP + usual physical therapy care, bipap group - BIPAP + usual physical therapy care and control group - usual physical therapy care), in a 1:1 allocation ratio and superiority.
The project will be carried out at Hospital João XXIII in the city of Campina Grande, Paraíba, Brazil. It is a private hospital affiliated with the SUS network, a reference in cardiology and especially in cardiac surgery for a good part of the state and surrounding states. It presents in its weekly program an average of 8 cardiac surgeries. The evaluation and intervention will take place in the ICU and ward.
Post-randomization exclusion criteria: In case of undertaking any treatment in the hospital environment that contraindicates participation in the study (pacemaker implantation, pneumothorax requiring chest drainage, for example), death or other decompensations not related to the research and return to the ICU .
Criteria for non-adherence to the intervention: Patient who does not perform 3 or more sessions in a row, who withdrew from participating in the study and who has some cardiac arrhythmia (atrial fibrillation, bradycardia) for two sessions even after medication used to contain and pause for rest.
Non-retention criteria: Patient who does not perform one of the reassessments. Professional eligibility criteria: Hospital staff physiotherapists and physiotherapy students with previous training in the research protocol.
Procedures for Conducting the Research The purpose of this project is to carry out a randomized clinical trial and verify the effectiveness of NIV compared to conventional physiotherapy in terms of the rate of pulmonary complications in patients undergoing cardiac surgery in a chosen hospital in the city of Campina Grande, Paraíba.
Thus, there will be a partnership with the Núcleo de Tecnologia Estratégicas em Saúde (NUTES) of the State University of Paraíba (UEPB) through the biomedical computing laboratory for the development of research aimed at the remote monitoring of health data through smartwatches and other devices that comply with international standardization norms for interoperability between health technologies. NUTES already collaborates with UFRN in several scientific and technological cooperation researches, so that the co-supervisor of the project, Prof Paulo Eduardo Barbosa made the strategic partnership possible, according to the attached document. NUTES' participation in this project will take place through the feasibility of remote monitoring technology via Smartwatch and the introduction of data collected on a specific platform.
For a better understanding and operationalization of the research, it was divided into 5 phases.
- st Phase: Documentary Survey and Consent At first, there was initial contact with the aforementioned hospital institution for consent to the research. At the same time, a documentary and systematic study on the subject was instituted, in order to base the research and identify possible indices and/or parameters that would add to the research in order to make it viable and absolutely realistic.
- nd Phase: Search and profile of NIV and Smartwatch devices Non-invasive ventilation (NIV) will be performed both in the ICU environment and in the ward for the intervention group. A BIPAP will be made available and a CPAP for the respective groups. The interface chosen will be the nasal mask, aiming at greater patient comfort. Thus, we will choose properly calibrated NIV devices on the market that provide better adaptation to patients. All the main information about users can be entered into the platform, such as gender, age, other illnesses, use of medication, and some special situations that can be verified in practice, in addition to information that may come from the monitoring carried out by the smartwatch on patients in the moment of data collection during NIV application. Thus, data from the patient's medical record will also be used. A large volume of data can be entered into the platform and used to generate a profile of cardiac patients selected for the survey. The smartwatch used will be from the Garmin brand and available for capturing Sao2 and VO2. The main functionalities of the Dashboard comprise the visualization of the data of the surgical patients submitted to NIV in the initial screen in a computer, being able to apply filters according to the interest of the researcher.
- rd Phase: Technical Study and applied tests This project is interested in three major aspects: the use of non-invasive ventilation in heart patients undergoing cardiac surgery; the automation of data collection using the smartwatch, making it practical, simple, accessible technology in order to become a predictor of safe discharge for these patients; finally, a survey of a large volume of data (verified in the analysis profile of the patients) that can generate subsidies for carrying out research and contribute to the increase of studies in the area of cardiopulmonary physiotherapy on technological bases.
- th Phase: Pilot Study - Practice After that, the surgeries will begin and the collection will consist of 6 patients, thus defining the beginning of the pilot study. Upon being notified of the weekly surgical schedule, the researcher in charge will randomize the patients. This register will contain the complete identification of the patient, type of surgery to which he will be submitted and the pathology. Thus, as the patients leave the surgical center and go to the ICU, they will follow the protocol so that the treatment due to the group to which the patient is allocated on the day after the surgery begins. It should be noted that the pilot study should only be started after approval by CEP. After completion of the pilot study, there will be an evaluation of the entire protocol so that possible flaws can be corrected before definitive collection.
- th Phase: Data collection It will consist of collecting data from patients in the post-randomization intervention and allocation of patients to a group, following the procedures of the protocol.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
- Model description
- Pacients will be divided into 3 groups (CPAP group - CPAP + usual physical therapy care, BiPAP group - BiPAP + usual physical therapy care, and Control group - usual physical therapy care) in a 1:1 allocation ratio. Control group will receive the usual physiotherapy treatment, as kinesiotherapy protocol. Treatment will be administered twice a day, starting in the ICU and progressing to the ward. In the CPAP group, nasal CPAP at 10cmH2O will be administered for 1 hour, twice a day, using an approved device. In BiPAP group, nasal BiPAP with IPAP of 13cmH2O and EPAP of 8cmH2O will be administered for 1 hour, twice a day, using an approved device. The NIV sessions will be conducted during the 5 days of hospitalization, both in the ICU and the ward. After the fifth day, patients in intervention groups will undergo reassessment using the same assessment instruments as before.
| Arm | Type | Receives |
|---|---|---|
| Control group 1 (usual care) | Active comparator | Procedure: Usual care in phisicaltherapyPatients undergo physiotherapy treatment twice daily, transitioning from the ICU to the ward. The treatment plan spans several days, starting on the first postoperative day after ICU discharge. In the ICU, Day 1 includes diaphragmatic breathing exercises, coughing stimulus, upper limb exercises (shoulder flexion/extension, abduction), and lower limb exercises (thigh flexion, dorsiflexion/plantarflexion). Day 2 involves diaphragmatic breathing, coughing stimulus, upper limb exercises, lower limb exercises, cycling for 3 minutes, and respiratory device exercises. Upon moving to the ward on Day 3, patients perform diaphragmatic breathing, coughing stimulus, upper limb exercises, lower limb exercises, and a 5-minute walk. Day 4 focuses on diaphragmatic breathing, coughing stimulus, and a 10-minute walk. Finally, on Day 5, patients engage in diaphragmatic breathing, coughing stimulus, and a 15-minute walk. |
| Intervention group 2 (CPAP) | Experimental | Procedure: CPAP, Procedure: Usual care in phisicaltherapyThey will be submitted to the same care as the control group, adding NIV with nasal CPAP 10cmH2O for 1 hour using device and brand approved by ANVISA, during the 5 days of hospitalization, both in the ICU and in the ward. The frequency of the sessions will be two (2) per day, in the morning and in the afternoon. Flexibility of time for carrying out the procedure is also planned, since in a hospital environment the patient can often undergo exams, other behaviors that may make it difficult to apply the protocol at the initially scheduled time. After the fifth day, the patient will be reassessed with the same instruments reported. |
| Intervention group 2 (BIPAP): | Experimental | Procedure: BIPAP, Procedure: Usual care in phisicaltherapyThey will undergo the same care as the control group, adding NIV with nasal BIPAP with IPAP of 13cmH2O and EPAP 8 cmH2O for 1 hour, using equipment and brand approved by ANVISA, during the 5 days of hospitalization, both in the ICU and in the ward . The frequency of the sessions will be two (2) per day, in the morning and in the afternoon. Flexibility of time for carrying out the procedure is also planned, since in a hospital environment the patient can often undergo exams, other behaviors that may make it difficult to apply the protocol at the initially scheduled time. After the fifth day, the patient will be reassessed with the same instruments reported. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- aged over 18 years
- stable from the hemodynamic point of view (controlled blood pressure, normocardic
- conscious and oriented and cooperative4
- without medical restrictions for carrying out the treatment
Key exclusion criteria (5 listed)
- Presence of uncontrolled cardiac arrhythmias (Examples: total atrioventricular block, type 2 2nd degree atrioventricular block, atrial fibrillation, sustained ventricular tachycardia)
- previous neuromuscular disease
- labyrinthitis and some orthopedic/skeletal muscle restriction.
- Unstable angina, stage 3 SAH (SBP ≥ 180 mmHg and/or DBP ≥ 110 mmHg at rest), HR > 120 bpm at rest, systemic arterial hypotension with clinical repercussions (SBP ≤ 90 mmHg and/or DBP ≤ 60 mmHg),(),
- aortic dissection.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CPAPUse of non-invasive ventilation in patients in group 2 with CPAP. | Procedure or surgery | Intervention group 2 (CPAP) |
| BIPAPUse of non-invasive ventilation in patients in group 3 with BIPAP. | Procedure or surgery | Intervention group 2 (BIPAP): |
| Usual care in phisicaltherapyPatients undergoing usual physiotherapy treatment, consisting of a kinesiotherapy protocol | Procedure or surgery | Control group 1 (usual care), Intervention group 2 (BIPAP):, Intervention group 2 (CPAP) |
Primary outcome
Pulmonary function
Time frame: Day 1 and day 5
All participants will undergo an evaluation by a CONTEC model spirometer (SPB80b, CHINA) to verify lung volumes and capacities. At least three tests will be performed, with a variation of less than 5% and the highest value obtained in one of the tests will be compared with the predicted values of pulmonary function parameters for the Brazilian population. FEV1 and FVC will be assessed. The predicted values will be calculated using the reference values (PEREIRA et al., 2007).
Length of hospital stay
Time frame: The length of hospital stay will be assessed and reported as the number of days from admission to discharge, measured up to 2 weeks after the date of randomization.
Absolute number of days of hospitalization up to 2 weeks after the date of randomization.
Presence of lung complications
Time frame: From the date of randomization to the date of the first documented progression or the date of death from any cause, whichever occurs first, measured up to 2 weeks after the date of hospital discharge.
assessment of the occurrence or absence of any complications related to the lungs during the hospitalization period.cause, whichever occurs first, measured up to 2 weeks
9 secondary outcomes
Score of the Minnesota Living with Heart Failure Questionnaire (MLHFQ) in Portuguese version
Time frame: Day 1 and Day 5
Funcional capacity
Time frame: Day 1 and Day 5
The global perception of change scale
Time frame: Day 1 and Day 5
The functional independence measure (MIF)
Time frame: Day 1 and Day 5
pO2 (partial pressure of oxygen)
Time frame: Days 1 and 2.
pCO2 (partial pressure of carbon dioxide)
Time frame: Days 1 and 2.
HCO3 (bicarbonate)
Time frame: Days 1 and 2.
Arterial Oxygen Saturation (SaO2)
Time frame: Days 1 and 2.
Base Excess (BE)
Time frame: Days 1 and 2.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jul 2023.
- Background: PubMed 28387685Hossen A, Jaju D, Al-Abri M, Al-Sabti H, Mukaddirov M, Hassan M, Al-Hashmi K. Investigation of heart rate variability of patients undergoing coronary artery bypass grafting (CABG). Technol Health Care. 2017;25(2):197-210. doi: 10.3233/THC-161260.
- Background: PubMed 18694656Du H, Newton PJ, Salamonson Y, Carrieri-Kohlman VL, Davidson PM. A review of the six-minute walk test: its implication as a self-administered assessment tool. Eur J Cardiovasc Nurs. 2009 Mar;8(1):2-8. doi: 10.1016/j.ejcnurse.2008.07.001. Epub 2008 Aug 9.
- Background: PubMed 25859310Shakouri SK, Salekzamani Y, Taghizadieh A, Sabbagh-Jadid H, Soleymani J, Sahebi L, Sahebi R. Effect of respiratory rehabilitation before open cardiac surgery on respiratory function: a randomized clinical trial. J Cardiovasc Thorac Res. 2015;7(1):13-7. doi: 10.15171/jcvtr.2015.03. Epub 2015 Mar 29.
- Background: PubMed 23288909Valkenet K, de Heer F, Backx FJ, Trappenburg JC, Hulzebos EH, Kwant S, van Herwerden LA, van de Port IG. Effect of inspiratory muscle training before cardiac surgery in routine care. Phys Ther. 2013 May;93(5):611-9. doi: 10.2522/ptj.20110475. Epub 2013 Jan 3.
- Background: PubMed 30581100Dos Santos TD, Pereira SN, Portela LOC, Cardoso DM, Lago PD, Dos Santos Guarda N, Moresco RN, Pereira MB, de Albuquerque IM. Moderate-to-high intensity inspiratory muscle training improves the effects of combined training on exercise capacity in patients after coronary artery bypass graft surgery: A randomized clinical trial. Int J Cardiol. 2019 Mar 15;279:40-46. doi: 10.1016/j.ijcard.2018.12.013. Epub 2018 Dec 10.
- Background: PubMed 12186831American Thoracic Society/European Respiratory Society. ATS/ERS Statement on respiratory muscle testing. Am J Respir Crit Care Med. 2002 Aug 15;166(4):518-624. doi: 10.1164/rccm.166.4.518. No abstract available.
- Background: PubMed 19838469Carvalho VO, Guimaraes GV, Carrara D, Bacal F, Bocchi EA. Validation of the Portuguese version of the Minnesota Living with Heart Failure Questionnaire. Arq Bras Cardiol. 2009 Jul;93(1):39-44. doi: 10.1590/s0066-782x2009000700008. English, Portuguese, Spanish.
- Background8. Vieira WO, Barbosa LK, Bezerra AS, et al. Test timed up and go and its correlation with age and functional exercise capacity in asymptomatic women. Fisioterapia em Movimento. 2017;30(3):463-471. doi:10.1590/1980-5918.030.003.AO04.
- Background: PubMed 23503902Bretan O, Silva Junior JE, Ribeiro OR, Corrente JE. Risk of falling among elderly persons living in the community: assessment by the Timed up and go test. Braz J Otorhinolaryngol. 2013 Jan-Feb;79(1):18-21. doi: 10.5935/1808-8694.20130004.
- Background: PubMed 19965089Behlouli H, Feldman DE, Ducharme A, Frenette M, Giannetti N, Grondin F, Michel C, Sheppard R, Pilote L. Identifying relative cut-off scores with neural networks for interpretation of the Minnesota Living with Heart Failure questionnaire. Annu Int Conf IEEE Eng Med Biol Soc. 2009;2009:6242-6. doi: 10.1109/IEMBS.2009.5334659.
- Background: PubMed 33020069Bai C, Chotirmall SH, Rello J, Alba GA, Ginns LC, Krishnan JA, Rogers R, Bendstrup E, Burgel PR, Chalmers JD, Chua A, Crothers KA, Duggal A, Kim YW, Laffey JG, Luna CM, Niederman MS, Raghu G, Ramirez JA, Riera J, Roca O, Tamae-Kakazu M, Torres A, Watkins RR, Barrecheguren M, Belliato M, Chami HA, Chen R, Cortes-Puentes GA, Delacruz C, Hayes MM, Heunks LMA, Holets SR, Hough CL, Jagpal S, Jeon K, Johkoh T, Lee MM, Liebler J, McElvaney GN, Moskowitz A, Oeckler RA, Ojanguren I, O'Regan A, Pletz MW, Rhee CK, Schultz MJ, Storti E, Strange C, Thomson CC, Torriani FJ, Wang X, Wuyts W, Xu T, Yang D, Zhang Z, Wilson KC. Updated guidance on the management of COVID-19: from an American Thoracic Society/European Respiratory Society coordinated International Task Force (29 July 2020). Eur Respir Rev. 2020 Oct 5;29(157):200287. doi: 10.1183/16000617.0287-2020. Print 2020 Sep 30.
- Background: PubMed 16450093Rodriguez P, Lellouche F, Aboab J, Buisson CB, Brochard L. Transcutaneous arterial carbon dioxide pressure monitoring in critically ill adult patients. Intensive Care Med. 2006 Feb;32(2):309-312. doi: 10.1007/s00134-005-0006-4. Epub 2006 Jan 31.
- Individual participant dataSharing planned: No
Related trials for Cardiac Surgical Procedures
Active, not recruiting
Shockwave™ vs Surgical Endarterectomy for Calcified Severe Common Femoral Artery Stenosis: Comparison of Efficacy, Safety and Long-Term Outcomes
Common Femoral Artery Stenosis, Calcification; Heart
Not yet recruitingObservational study
Systematic Intraoperative Cell Salvage in On-Pump Cardiac Surgery Within a Mature Patient Blood Management Programme
Cardiac Surgical Procedures, Blood Transfusion
Recruiting
Change in Platelet Lipid Metabolism and Procoagulant Phenotype Induced by Cardiopulmonary Bypass. Impact on Postoperative Inflammatory Response and Bleeding Complications During Cardiac Surgery.
Cardiac Surgery, Cardiopulmonary Bypass
Not yet recruiting
Effect of Warm Footbath Combined With Relaxation Exercise on Pain and Anxiety During Chest Tube Removal After Cardiac Surgery
Chest Tube Removal
RecruitingObservational study
The Impact of Fast-Track Anesthesia on Postoperative Neurocognitive Function in Patients Undergoing Cardiac Surgery
Delirium - Postoperative, Cardiac Surgery
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CPAP and BIPAP in people with Cardiac Surgical Procedures and Continuous Positive Airway Pressure, run by Universidade Federal do Rio Grande do Norte at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 28 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Eder R Araújo, doctoral (+5583988998813, eder.rodrigues.araujo@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pulmonary function (time frame: Day 1 and day 5). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05966337, which also lists 15 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jul 2023.