Bariatric Surgery CandidateNCT04805476
Prophylactic Use of Noninvasive Ventilation in the Postoperative Period of Bariatric Surgery
A study testing Non invasive mechanical ventilation and GP in people with Bariatric Surgery Candidate and Obesity, Morbid, run by Hospital de Clinicas de Porto Alegre at 1 site in Brazil.
Trial summary
Comorbidities associated with severe obesity determine an important public health problem. Few methods are considered potentially effective for the treatment of severe obesity and the clinical relevance of bariatric surgery is growing, as well as the number of procedures performed. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Bariatric Surgery Candidate, Obesity, Morbid, Ventilatory Failure
- What is being tested?
- Non invasive mechanical ventilation and GP
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 31 participants
- Where
- 1 siteBrazil
- Study dates
- 1 Mar 2017to 31 Jul 2018
- 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 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Adult patients undergoing bariatric surgery
Who cannot join
- Absolute or relative contraindications to the use of NIV
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Hospital de Clínicas de Porto Alegre
Porto Alegre, Rio Grande do Sul
About this study
Comorbidities associated with severe obesity determine an important public health problem. Few methods are considered potentially effective for the treatment of severe obesity and the clinical relevance of bariatric surgery is growing, as well as the number of procedures performed. The insertion of the physiotherapist in the multiprofessional team responsible for performing the surgical procedure is essential from the preoperative screening and evaluation to the prevention and treatment of postoperative complications. Therefore, the physiopathological aspects involved with severe obesity, the technical aspects and risks of the surgical procedure, as well as the physiotherapeutic techniques that have scientific proof must be known by the physiotherapist responsible for the surgical follow-up of the patient. In this context, the use of non-invasive ventilation (NIV) in the postoperative period of bariatric surgery has ample therapeutic potential. The present research project aims to evaluate the immediate prophylactic use of NIV on the respiratory and functional recovery of the patients.
Read the detailed description
The study will be performed at the surgical center of the Hospital de Clínicas of Porto Alegre. After approval by the Research Ethics Committee, patients must sign the Term of Consent for inclusion in the study. A blinded investigator will record clinical, anthropometric, pulmonary function tests, and functional measures. Patients submitted to open bariatric surgery will be divided into two groups for the use of NIV: immediate post-extubation (IG) and non-intervention (standard group [GP]). Patients will be randomly assigned to the groups. All subjects will undergo general anesthesia and postoperative analgesia, using a standardized surgical team approach. Patients who present the contraindication criteria for the use of NIV will be excluded from the study.
After the surgical procedure and extubation, GP subjects will receive oxygen therapy through a nasal cannula with 4 to 6 L / min of oxygen according to the team routine and patient need. The subjects in the immediate intervention group (GI) will be extubated and placed in NIV the moment they enter the recovery room through a portable ventilator (Esprit ® or BiPAP Vision ®, Respironics) in face mask. The parameters will be adjusted as follows: FiO2 = 50%, positive expiratory pressure (EPAP, starting at 4-6 cmH2O and adjusting 1-2 cmH2O to avoid snoring, apnea, paradoxical breathing and desaturations) and adjusted inspiratory positive pressure (IPAP) to maintain a tidal volume of 400 to 500 ml, maintaining IPAP <15cmH2O17. Individuals will receive this ventilatory support for 1 hour. After this period the patients will be submitted to the same care of GP patients. Measurement of respiratory muscle strength and lung function will be recorded in Time 1 (in the preoperative period), Time 2 (at the time of entry of the recovery room) and Time 3 (1 hour after extubation, with withdrawal of the support ventilatory). Vital signs (heart rate, peripheral O2 Saturation and Blood Pressure) will also be recorded through the multi-parameter monitor (IntelliVue MP40).
The functional evaluation will be performed in the period of the initial data collection through the Functional Status Score for the ICU (FSS-ICU) and Functional Independence Measure (MIF). Patients will be monitored during the hospitalization period until hospital discharge and records of postoperative complications (radiological changes, infections and surgical anastomosis fistulas) will be recorded by blinded evaluator. The final evaluation will be done through the MIF, through telephone contact 1 month after the surgery.
During the study participation patients may present with discomfort, nausea, vomiting and / or pain related to the use of non-invasive ventilation and procedures performed to evaluate muscle strength, lung function and functionality. In a study with methodology and similar population, such risks / complications were not reported16, however, if they occur, the procedures will be immediately interrupted and patients will be assisted by the study researchers in order to preserve the patients and the reliability of the results.
- Being tested
- Non invasive mechanical ventilation, GP
- Medical subject headings
- Obesity, Morbid, Hypoventilation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Non invasive mechanical ventilationDevice
Prophylactic non invasive mechanical ventilation
GPDevice
GP subjects will receive oxygen therapy through a nasal cannula with 4 to 6 L / min of oxygen according to team routine and patient need.
| Study group | Role | What they receive |
|---|---|---|
| Non invasive mechanical ventilation | Experimental | The subjects in the immediate intervention group (GI) will be extubated and placed in NIV the moment they enter the recovery room through a portable ventilator (Esprit ® or BiPAP Vision ®, Respironics) in face mask. The parameters will be adjusted as follows: FiO2 = 50%, positive expiratory pressure (EPAP, starting at 4-6 cmH2O and adjusting 1-2 cmH2O to avoid snoring, apnea, paradoxical breathing and desaturations) and adjusted inspiratory positive pressure (IPAP) to maintain a tidal volume of 400 to 500 ml, maintaining IPAP <15cmH2O17. Individuals will receive this ventilatory support for 1 hour. After this period the patients will be submitted to the same care of GP patients. Receives: Device: Non invasive mechanical ventilation |
| Usual care | Active comparator | Subjects will receive oxygen therapy through a nasal cannula with 4 to 6 L / min of oxygen according to the team routine and patient need. Receives: Device: GP |
What is being measured
The primary outcome is the main question the study is designed to answer.
Forced Vital Capacity (FVC)
Larger volume of air mobilized on an exhalation.
Measured: Preoperative
Forced Vital Capacity (FVC)
Larger volume of air mobilized on an exhalation.
Measured: 10 minutes after admission to the recovery room
Forced Vital Capacity (FVC)
Larger volume of air mobilized on an exhalation.
Measured: 1 hour after admission to the recovery room
Forced expiratory volume in one second (FEV1)
Volume of air exhaled in the first second during the FVC maneuver.
Measured: Preoperative
Forced expiratory volume in one second (FEV1)
Volume of air exhaled in the first second during the FVC maneuver.
Measured: 10 minutes after admission to the recovery room
Forced expiratory volume in one second (FEV1)
Volume of air exhaled in the first second during the FVC maneuver.
Measured: 1 hour after admission to the recovery room
FEV1/FVC ratio
Ratio between forced expiratory volume in the first second and vital capacity.
Measured: Preoperative
FEV1/FVC ratio
Ratio between forced expiratory volume in the first second and vital capacity.
Measured: 10 minutes after admission to the recovery room
FEV1/FVC ratio
Ratio between forced expiratory volume in the first second and vital capacity.
Measured: 1 hour after admission to the recovery room
Peak expiratory flow (PEF)
Maximum air flow during the FVC maneuver.
Measured: Preoperative
Peak expiratory flow (PEF)
Maximum air flow during the FVC maneuver.
Measured: 10 minutes after admission to the recovery room
Peak expiratory flow (PEF)
Maximum air flow during the FVC maneuver.
Measured: 1 hour after admission to the recovery room
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2021
- Study start1 Mar 2017
- Primary completion31 May 2018
- Study completion31 Jul 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bariatric Surgery CandidateStudies of the same condition, open and under way.
- More trials run by Hospital de Clinicas de Porto AlegreThe sponsor's other registered studies.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital de Clinicas de Porto Alegre
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Fábio Di Naso, PhD, Principal investigator, Federal University of Rio Grande do Sul
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04805476
- Sponsor's protocol ID
- 50468415.1.0000.5327
- Status last verified
- Mar 2021
- First submitted
- 3 Nov 2020
- Last updated
- 18 Mar 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prophylactic Use of Noninvasive Ventilation in the Postoperative Period of Bariatric Surgery
- ClinicalTrials.gov ID
- NCT04805476
- Acronym / sponsor ID
- 50468415.1.0000.5327
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- Hospital de Clinicas de Porto AlegreUniversity, hospital or other
- Study start
- 1 Mar 2017 (actual)
- Primary completion
- 31 May 2018 (actual)
- Study completion
- 31 Jul 2018 (actual)
- First posted
- 18 Mar 2021 (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.
Comorbidities associated with severe obesity determine an important public health problem. Few methods are considered potentially effective for the treatment of severe obesity and the clinical relevance of bariatric surgery is growing, as well as the number of procedures performed. The insertion of the physiotherapist in the multiprofessional team responsible for performing the surgical procedure is essential from the preoperative screening and evaluation to the prevention and treatment of postoperative complications. Therefore, the physiopathological aspects involved with severe obesity, the technical aspects and risks of the surgical procedure, as well as the physiotherapeutic techniques that have scientific proof must be known by the physiotherapist responsible for the surgical follow-up of the patient. In this context, the use of non-invasive ventilation (NIV) in the postoperative period of bariatric surgery has ample therapeutic potential. The present research project aims to evaluate the immediate prophylactic use of NIV on the respiratory and functional recovery of the patients.
Detailed description
The study will be performed at the surgical center of the Hospital de Clínicas of Porto Alegre. After approval by the Research Ethics Committee, patients must sign the Term of Consent for inclusion in the study. A blinded investigator will record clinical, anthropometric, pulmonary function tests, and functional measures. Patients submitted to open bariatric surgery will be divided into two groups for the use of NIV: immediate post-extubation (IG) and non-intervention (standard group [GP]). Patients will be randomly assigned to the groups. All subjects will undergo general anesthesia and postoperative analgesia, using a standardized surgical team approach. Patients who present the contraindication criteria for the use of NIV will be excluded from the study.
After the surgical procedure and extubation, GP subjects will receive oxygen therapy through a nasal cannula with 4 to 6 L / min of oxygen according to the team routine and patient need. The subjects in the immediate intervention group (GI) will be extubated and placed in NIV the moment they enter the recovery room through a portable ventilator (Esprit ® or BiPAP Vision ®, Respironics) in face mask. The parameters will be adjusted as follows: FiO2 = 50%, positive expiratory pressure (EPAP, starting at 4-6 cmH2O and adjusting 1-2 cmH2O to avoid snoring, apnea, paradoxical breathing and desaturations) and adjusted inspiratory positive pressure (IPAP) to maintain a tidal volume of 400 to 500 ml, maintaining IPAP <15cmH2O17. Individuals will receive this ventilatory support for 1 hour. After this period the patients will be submitted to the same care of GP patients. Measurement of respiratory muscle strength and lung function will be recorded in Time 1 (in the preoperative period), Time 2 (at the time of entry of the recovery room) and Time 3 (1 hour after extubation, with withdrawal of the support ventilatory). Vital signs (heart rate, peripheral O2 Saturation and Blood Pressure) will also be recorded through the multi-parameter monitor (IntelliVue MP40).
The functional evaluation will be performed in the period of the initial data collection through the Functional Status Score for the ICU (FSS-ICU) and Functional Independence Measure (MIF). Patients will be monitored during the hospitalization period until hospital discharge and records of postoperative complications (radiological changes, infections and surgical anastomosis fistulas) will be recorded by blinded evaluator. The final evaluation will be done through the MIF, through telephone contact 1 month after the surgery.
During the study participation patients may present with discomfort, nausea, vomiting and / or pain related to the use of non-invasive ventilation and procedures performed to evaluate muscle strength, lung function and functionality. In a study with methodology and similar population, such risks / complications were not reported16, however, if they occur, the procedures will be immediately interrupted and patients will be assisted by the study researchers in order to preserve the patients and the reliability of the results.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Non invasive mechanical ventilation | Experimental | Device: Non invasive mechanical ventilationThe subjects in the immediate intervention group (GI) will be extubated and placed in NIV the moment they enter the recovery room through a portable ventilator (Esprit ® or BiPAP Vision ®, Respironics) in face mask. The parameters will be adjusted as follows: FiO2 = 50%, positive expiratory pressure (EPAP, starting at 4-6 cmH2O and adjusting 1-2 cmH2O to avoid snoring, apnea, paradoxical breathing and desaturations) and adjusted inspiratory positive pressure (IPAP) to maintain a tidal volume of 400 to 500 ml, maintaining IPAP <15cmH2O17. Individuals will receive this ventilatory support for 1 hour. After this period the patients will be submitted to the same care of GP patients. |
| Usual care | Active comparator | Device: GPSubjects will receive oxygen therapy through a nasal cannula with 4 to 6 L / min of oxygen according to the team routine and patient need. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Adult patients undergoing bariatric surgery
Key exclusion criteria (1 listed)
- Absolute or relative contraindications to the use of NIV
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 |
|---|---|---|
| Non invasive mechanical ventilationProphylactic non invasive mechanical ventilation | Device | Non invasive mechanical ventilation |
| GPGP subjects will receive oxygen therapy through a nasal cannula with 4 to 6 L / min of oxygen according to team routine and patient need. | Device | Usual care |
Primary outcome
Forced Vital Capacity (FVC)
Time frame: Preoperative
Larger volume of air mobilized on an exhalation.
Forced Vital Capacity (FVC)
Time frame: 10 minutes after admission to the recovery room
Larger volume of air mobilized on an exhalation.
Forced Vital Capacity (FVC)
Time frame: 1 hour after admission to the recovery room
Larger volume of air mobilized on an exhalation.
Forced expiratory volume in one second (FEV1)
Time frame: Preoperative
Volume of air exhaled in the first second during the FVC maneuver.
Forced expiratory volume in one second (FEV1)
Time frame: 10 minutes after admission to the recovery room
Volume of air exhaled in the first second during the FVC maneuver.
Forced expiratory volume in one second (FEV1)
Time frame: 1 hour after admission to the recovery room
Volume of air exhaled in the first second during the FVC maneuver.
FEV1/FVC ratio
Time frame: Preoperative
Ratio between forced expiratory volume in the first second and vital capacity.
FEV1/FVC ratio
Time frame: 10 minutes after admission to the recovery room
Ratio between forced expiratory volume in the first second and vital capacity.
FEV1/FVC ratio
Time frame: 1 hour after admission to the recovery room
Ratio between forced expiratory volume in the first second and vital capacity.
Peak expiratory flow (PEF)
Time frame: Preoperative
Maximum air flow during the FVC maneuver.
Peak expiratory flow (PEF)
Time frame: 10 minutes after admission to the recovery room
Maximum air flow during the FVC maneuver.
Peak expiratory flow (PEF)
Time frame: 1 hour after admission to the recovery room
Maximum air flow during the FVC maneuver.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Mar 2021.
- Individual participant dataSharing planned: No
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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.
Fábio Di Naso, PhD principal investigator
Federal University of Rio Grande do Sul
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Non invasive mechanical ventilation and GP in people with Bariatric Surgery Candidate and Obesity, Morbid, run by Hospital de Clinicas de Porto Alegre 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 1 inclusion and 1 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: finished, as of the sponsor's last update on 18 Mar 2021. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Forced Vital Capacity (FVC) (time frame: Preoperative). The study lists 12 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 18 Mar 2021.