DyspneaNCT06255327
Effectiveness of I COUGH Program to Dyspnea, Respiratory Parameters, Mobility and Pain After Major Abdominal Surgery
A study testing I COUGH care program in people with Dyspnea and Pain, run by Yeditepe University at 3 sites in Libya.
Trial summary
The purpose of the current study was to investigate the effect of the I COUGH care program following major abdominal surgery dyspnea, oxygen saturation, pulmonary function, mobility, and pain after major abdominal surgery (MAS), participants were subjected to the "I COUGH" care program designed to support their health… Read more about this study
- Who is it for?
- Ages 30 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Dyspnea, Pain, Respiratory Insufficiency
- What is being tested?
- I COUGH care program
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 3 sitesLibya
- Study dates
- 26 Dec 2023to 10 Jan 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 30 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Volunteering to participate in the study.
- Eligible patients are adults of both sexes between 30-60 years (Through the study, we are trying to reduce the variance and confounding factors that may arise from including patients who are less than 30 years old due to different stages of growth, physical abilities, hormonal levels, etc., or over 60 years old due to the prevalence of chronic diseases or diseases associated with aging).
- Patients underwent elective abdominal surgery that required general anaesthesia and hospital stay e.g., Hernia repair, gall bladder removal, exploratory laparotomy, morbid obesity, ovarian cyst, Sigmoid diverticulitis, appendicitis, or other abdominal cavity procedures performed by laparoscopy and conventional laparotomy with a 5 cm or less incision above or extending above the umbilicus. (Incisions > 5cm may affect on possible results might be impacted in terms of: Increased risk of infection, risk of bleeding, pain, and discomfort during ambulation).
Who cannot join
- The patient complains of an unstable heart rate or cardiac condition.
- Symptomatic heart failure, unstable angina.
- Pulmonary Hypertension
- Unstable hypertension
- The patient underwent organ transplants.
- The patient presented an aneurysm of any arterial segment.
Show all 11Show fewer
- Serious condition or transferred to the intensive care unit after surgery.
- Severe nephropathy.
- A patient with cancer.
- Cerebrovascular accident / Stroke.
- Patient with balance or vestibular disorder.
Trial locations and contacts
3 sites in 1 country.
Libya3 sites
AL-ASSEMA Hospital
Tripoli, 21821
AL-KHALIL Hospital
Tripoli, 21821
ROYAL Clinic
Tripoli, 21821
About this study
Official title: The Effectiveness of The "I Cough" Care Program to Dyspnea, Respiratory Parameters, Mobility and Pain After Major Abdominal Surgery.
The purpose of the current study was to investigate the effect of the I COUGH care program following major abdominal surgery dyspnea, oxygen saturation, pulmonary function, mobility, and pain after major abdominal surgery (MAS), participants were subjected to the "I COUGH" care program designed to support their health condition and reduce complications. The study aimed to investigate a simple and inexpensive pulmonary care program that can be easily understood and remembered by patients, their families, and medical staff.
Ho: The I COUGH care program after MAS does not improves pulmonary functions, oxygen saturation, mobility and decrease dyspnea and pain after MAS.
H1: The I COUGH care program improves pulmonary functions, oxygen saturation mobility and decrease dyspnea and pain after MAS.
Read the detailed description
A total of 60 adult individuals aged between 30 and 60 years (mean age of 39.9±8.82) comprising 13 males and 47 females underwent major abdominal surgery requiring general anesthesia and hospitalization were invited to study. Patients were randomly assigned to either the Control Group (CG, n=30) or the Experimental Group (EG, n=30) using the block randomization method. Patients in the EG participated in the I COUGH care program included flow-incentive spirometer, oral care, coughing and breathing exercises, patient, and family education, getting out of bed, and elevating the head of the bed by more than 30 degrees for 3 days post-surgery. The patients in the CG did not undergo any interventions. All participants were assessed in terms of vital signs as heart rate, blood pressure, respiratory rate, and oxygen saturation. Moreover, dyspnea was assessed using the Modified Borg dyspnea Scale, pulmonary functions were evaluated using spirometry, mobility was assessed by Activity and Mobility Promotion scale and pain assessed Visual Analog Scale. Data were collected from all patients at baseline 10 h after the first day of surgery and on the day of discharge from the hospitals. The findings of the present study revealed that the I COUGH care program effectively improved pulmonary function and blood oxygenation, reduced the incidence of dyspnea, increased mobility, and decreased postoperative pain, with a statistically significant difference between the experimental and control groups (p<0.05).
- Conditions
- Dyspnea, Pain, Respiratory Insufficiency, Mobility Limitation
- Being tested
- I COUGH care program
- Keywords
- I COUGH, Dyspnea, Respiratory Parameters, Pain, Major Abdominal Surgery
- Medical subject headings
- Dyspnea, Pain, Respiratory Insufficiency, Mobility Limitation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
I COUGH care programOther
The I COUGH program, initiated 10 hours after surgery, emphasizes the following elements:
Incentive spirometry: Encouraging patients to use the Flow-IS device ten times every two hours for three days.
Coughing and deep breathing: Participants should perform 3-5 coughs and deep breaths every 2 hours for 3 days.
Oral care: Brushing teeth and using mouthwash twice daily between 8:00 a.m. and 8:00 p.m. Mouth brushes should be sterile, and non-alcoholic mouthwash is recommended.
Understanding (education): Patients and their relatives receive instructions on the care program and steps to follow.
Getting out of bed: Patients are encouraged to sit in a chair at least once and walk at least 3 times per day in the room and corridor with assistance as needed.
Head-of-bed elevation: Keeping the head of the bed elevated more than 30 degrees.
| Study group | Role | What they receive |
|---|---|---|
| Control group | No intervention | The control group participants underwent evaluations on the first day after 10 hours following surgery and, on the day, they were discharged from the clinic, by using pulse oximetry, sphygmometer, spirometry tests, VAS, MBDS and activity and mobility promotion (AMP). Participants in the control group were not given any information or training before or after the operation, and they were on routine hospital care. |
| Experimental group | Experimental | The participants in the experimental group underwent the application of I COUGH (Incentive spirometry, Coughing/Deep breathing, Oral care, Understanding (Education of patient and family), Getting out of bed, and raising the Head of the bed). The participants underwent evaluations on the first day after 10 hours following surgery and, on the day, they were discharged from the clinic. Including Pulse Oximetry, Sphygmometer, Spirometry Tests, VAS, MBDS, AMP. Receives: Other: I COUGH care program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Heart Rate (HR)
The number of heart beats per minute.
Measured: 3 days of postoperatively
Systolic Blood pressure (SBP)
The minimum pressure recorded just prior to the next contraction.
Measured: 3 days of postoperatively
Diastolic Blood pressure (DBP)
The maximum blood pressure during contraction of the ventricles.
Measured: 3 days of postoperatively
Respiratory Rate (RR)
The number of breaths they take per minute.
Measured: 3 days of postoperatively
Oxygen Saturation (SPO2)
A pulse oximeter reading that indicates what percentage of your blood is saturated.
Measured: 3 days of postoperatively
Modified Borg Dyspnea Scale (MBDS)
A valid and reliable tool to measure the intensity of dyspnea. It is a categorical scale with ratio properties, rating from 0 to 10, 0 being not dyspneic at all and 10 being maximally dyspneic.
Measured: 3 days of postoperatively
Pulmonary Function Test FVC
Noninvasive test that show how well the lungs are working, measuring of FVC
Measured: 3 days of postoperatively
Pulmonary Function Test FEV
Noninvasive tests that show how well the lungs are working, measuring of FEV
Measured: 3 days of postoperatively
Pulmonary Function Test FEV1/FVC
Noninvasive tests that show how well the lungs are working, measuring of FEV1/FVC
Measured: 3 days of postoperatively
Pulmonary Function Test PEFR
Noninvasive tests that show how well the lungs are working, measuring of PEFR.
Measured: 3 days of postoperatively
Activity and Mobility Promotion (AMP)
AMP is based on measuring increasing patient mobility during hospital stay. The initial goals of this program included mobilization of each patient 3 times per day, documentation of patient mobility levels on the AMP scale.
Measured: 3 days of postoperatively
Visual Analogue Scale (VAS)
This measure is based on self-reported symptoms and is recorded with a single mark placed along a 10-cm line, which represents a continuum between "no pain" on the left end (0 cm) and "worst pain" on the right end. to determine the intensity of pain and its enhancement when coughing in the postoperative area.
Measured: 3 days of postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2024
- Study start26 Dec 2023
- Primary completion5 Jan 2024
- Study completion10 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (54)Papers the sponsor has linked to this study.
- Other trials for DyspneaStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Sequential
- Model description
- The sample of the study (n=60) consisted of patients underwent major abdominal surgery required general anesthesia and hospital stay who got diagnosed by consultant general and bariatric surgery, being between 30-60 years old (39.9±8.82 years old; 47 F/ 13 M) volunteered to attend this study. The participants were randomly divided into two groups.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yeditepe University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Feras M Tana, MSc, Principal investigator, Yeditepe University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06255327
- Sponsor's protocol ID
- YTU.PT.TH.01/2023
- Status last verified
- May 2024
- First submitted
- 25 Dec 2023
- Last updated
- 6 May 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Branson RD. The scientific basis for postoperative respiratory care. Respir Care. 2013 Nov;58(11):1974-84. doi: 10.4187/respcare.02832.
PubMed 24155356Moore JA, Conway DH, Thomas N, Cummings D, Atkinson D. Impact of a peri-operative quality improvement programme on postoperative pulmonary complications. Anaesthesia. 2017 Mar;72(3):317-327. doi: 10.1111/anae.13763. Epub 2017 Jan 4.
PubMed 28054356Smetana GW. Postoperative pulmonary complications: an update on risk assessment and reduction. Cleve Clin J Med. 2009 Nov;76 Suppl 4:S60-5. doi: 10.3949/ccjm.76.s4.10.
PubMed 19880838Odor PM, Bampoe S, Gilhooly D, Creagh-Brown B, Moonesinghe SR. Perioperative interventions for prevention of postoperative pulmonary complications: systematic review and meta-analysis. BMJ. 2020 Mar 11;368:m540. doi: 10.1136/bmj.m540.
PubMed 32161042Boden I, Skinner EH, Browning L, Reeve J, Anderson L, Hill C, Robertson IK, Story D, Denehy L. Preoperative physiotherapy for the prevention of respiratory complications after upper abdominal surgery: pragmatic, double blinded, multicentre randomised controlled trial. BMJ. 2018 Jan 24;360:j5916. doi: 10.1136/bmj.j5916.
PubMed 29367198Brooks-Brunn JA. Predictors of postoperative pulmonary complications following abdominal surgery. Chest. 1997 Mar;111(3):564-71. doi: 10.1378/chest.111.3.564.
PubMed 9118688Manzano RM, Carvalho CR, Saraiva-Romanholo BM, Vieira JE. Chest physiotherapy during immediate postoperative period among patients undergoing upper abdominal surgery: randomized clinical trial. Sao Paulo Med J. 2008 Sep;126(5):269-73. doi: 10.1590/s1516-31802008000500005.
PubMed 19099160Fagevik Olsen M, Hahn I, Nordgren S, Lonroth H, Lundholm K. Randomized controlled trial of prophylactic chest physiotherapy in major abdominal surgery. Br J Surg. 1997 Nov;84(11):1535-8. doi: 10.1111/j.1365-2168.1997.02828.x.
PubMed 9393272Siafakas NM, Mitrouska I, Bouros D, Georgopoulos D. Surgery and the respiratory muscles. Thorax. 1999 May;54(5):458-65. doi: 10.1136/thx.54.5.458. No abstract available.
PubMed 10212115Jammer I, Wickboldt N, Sander M, Smith A, Schultz MJ, Pelosi P, Leva B, Rhodes A, Hoeft A, Walder B, Chew MS, Pearse RM; European Society of Anaesthesiology (ESA) and the European Society of Intensive Care Medicine (ESICM); European Society of Anaesthesiology; European Society of Intensive Care Medicine. Standards for definitions and use of outcome measures for clinical effectiveness research in perioperative medicine: European Perioperative Clinical Outcome (EPCO) definitions: a statement from the ESA-ESICM joint taskforce on perioperative outcome measures. Eur J Anaesthesiol. 2015 Feb;32(2):88-105. doi: 10.1097/EJA.0000000000000118.
PubMed 25058504Cheifetz O, Lucy SD, Overend TJ, Crowe J. The effect of abdominal support on functional outcomes in patients following major abdominal surgery: a randomized controlled trial. Physiother Can. 2010 Summer;62(3):242-53. doi: 10.3138/physio.62.3.242. Epub 2010 Jul 23.
PubMed 21629603Smith PR, Baig MA, Brito V, Bader F, Bergman MI, Alfonso A. Postoperative pulmonary complications after laparotomy. Respiration. 2010;80(4):269-74. doi: 10.1159/000253881. Epub 2009 Oct 28.
PubMed 19864881Lawrence VA, Hilsenbeck SG, Mulrow CD, Dhanda R, Sapp J, Page CP. Incidence and hospital stay for cardiac and pulmonary complications after abdominal surgery. J Gen Intern Med. 1995 Dec;10(12):671-8. doi: 10.1007/BF02602761.
PubMed 8770719Nafiu OO, Ramachandran SK, Ackwerh R, Tremper KK, Campbell DA Jr, Stanley JC. Factors associated with and consequences of unplanned post-operative intubation in elderly vascular and general surgery patients. Eur J Anaesthesiol. 2011 Mar;28(3):220-4. doi: 10.1097/EJA.0b013e328342659c.
PubMed 21191304Miskovic A, Lumb AB. Postoperative pulmonary complications. Br J Anaesth. 2017 Mar 1;118(3):317-334. doi: 10.1093/bja/aex002.
PubMed 28186222
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effectiveness of The "I Cough" Care Program to Dyspnea, Respiratory Parameters, Mobility and Pain After Major Abdominal Surgery.
- ClinicalTrials.gov ID
- NCT06255327
- Acronym / sponsor ID
- YTU.PT.TH.01/2023
- Conditions
- Dyspnea, Pain, Respiratory Insufficiency, Mobility Limitation
- Keywords
- I COUGH, Dyspnea, Respiratory Parameters, Pain, Major Abdominal Surgery
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Yeditepe UniversityUniversity, hospital or other
- Study start
- 26 Dec 2023 (actual)
- Primary completion
- 5 Jan 2024 (actual)
- Study completion
- 10 Jan 2024 (actual)
- First posted
- 13 Feb 2024 (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 purpose of the current study was to investigate the effect of the I COUGH care program following major abdominal surgery dyspnea, oxygen saturation, pulmonary function, mobility, and pain after major abdominal surgery (MAS), participants were subjected to the "I COUGH" care program designed to support their health condition and reduce complications. The study aimed to investigate a simple and inexpensive pulmonary care program that can be easily understood and remembered by patients, their families, and medical staff.
Ho: The I COUGH care program after MAS does not improves pulmonary functions, oxygen saturation, mobility and decrease dyspnea and pain after MAS.
H1: The I COUGH care program improves pulmonary functions, oxygen saturation mobility and decrease dyspnea and pain after MAS.
Detailed description
A total of 60 adult individuals aged between 30 and 60 years (mean age of 39.9±8.82) comprising 13 males and 47 females underwent major abdominal surgery requiring general anesthesia and hospitalization were invited to study. Patients were randomly assigned to either the Control Group (CG, n=30) or the Experimental Group (EG, n=30) using the block randomization method. Patients in the EG participated in the I COUGH care program included flow-incentive spirometer, oral care, coughing and breathing exercises, patient, and family education, getting out of bed, and elevating the head of the bed by more than 30 degrees for 3 days post-surgery. The patients in the CG did not undergo any interventions. All participants were assessed in terms of vital signs as heart rate, blood pressure, respiratory rate, and oxygen saturation. Moreover, dyspnea was assessed using the Modified Borg dyspnea Scale, pulmonary functions were evaluated using spirometry, mobility was assessed by Activity and Mobility Promotion scale and pain assessed Visual Analog Scale. Data were collected from all patients at baseline 10 h after the first day of surgery and on the day of discharge from the hospitals. The findings of the present study revealed that the I COUGH care program effectively improved pulmonary function and blood oxygenation, reduced the incidence of dyspnea, increased mobility, and decreased postoperative pain, with a statistically significant difference between the experimental and control groups (p<0.05).
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- The sample of the study (n=60) consisted of patients underwent major abdominal surgery required general anesthesia and hospital stay who got diagnosed by consultant general and bariatric surgery, being between 30-60 years old (39.9±8.82 years old; 47 F/ 13 M) volunteered to attend this study. The participants were randomly divided into two groups.
| Arm | Type | Receives |
|---|---|---|
| Control group | No intervention | –The control group participants underwent evaluations on the first day after 10 hours following surgery and, on the day, they were discharged from the clinic, by using pulse oximetry, sphygmometer, spirometry tests, VAS, MBDS and activity and mobility promotion (AMP). Participants in the control group were not given any information or training before or after the operation, and they were on routine hospital care. |
| Experimental group | Experimental | Other: I COUGH care programThe participants in the experimental group underwent the application of I COUGH (Incentive spirometry, Coughing/Deep breathing, Oral care, Understanding (Education of patient and family), Getting out of bed, and raising the Head of the bed). The participants underwent evaluations on the first day after 10 hours following surgery and, on the day, they were discharged from the clinic. Including Pulse Oximetry, Sphygmometer, Spirometry Tests, VAS, MBDS, AMP. |
Who may qualify
- Ages
- 30 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Volunteering to participate in the study.
- Eligible patients are adults of both sexes between 30-60 years (Through the study, we are trying to reduce the variance and confounding factors that may arise from including patients who are less than 30 years old due to different stages of growth, physical abilities, hormonal levels, etc., or over 60 years old due to the prevalence of chronic diseases or diseases associated with aging).
- Patients underwent elective abdominal surgery that required general anaesthesia and hospital stay e.g., Hernia repair, gall bladder removal, exploratory laparotomy, morbid obesity, ovarian cyst, Sigmoid diverticulitis, appendicitis, or other abdominal cavity procedures performed by laparoscopy and conventional laparotomy with a 5 cm or less incision above or extending above the umbilicus. (Incisions > 5cm may affect on possible results might be impacted in terms of: Increased risk of infection, risk of bleeding, pain, and discomfort during ambulation).
Key exclusion criteria (11 listed)
- The patient complains of an unstable heart rate or cardiac condition.
- Symptomatic heart failure, unstable angina.
- Pulmonary Hypertension
- Unstable hypertension
- The patient underwent organ transplants.
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 |
|---|---|---|
| I COUGH care programThe I COUGH program, initiated 10 hours after surgery, emphasizes the following elements: Incentive spirometry: Encouraging patients to use the Flow-IS device ten times every two hours for three days. Coughing and deep breathing: Participants should perform 3-5 coughs and deep breaths every 2 hours for 3 days. Oral care: Brushing teeth and using mouthwash twice daily between 8:00 a.m. and 8:00 p.m. Mouth brushes should be sterile, and non-alcoholic mouthwash is recommended. Understanding (education): Patients and their relatives receive instructions on the care program and steps to follow. Getting out of bed: Patients are encouraged to sit in a chair at least once and walk at least 3 times per day in the room and corridor with assistance as needed. Head-of-bed elevation: Keeping the head of the bed elevated more than 30 degrees. | Other | Experimental group |
Primary outcome
Heart Rate (HR)
Time frame: 3 days of postoperatively
The number of heart beats per minute.
Systolic Blood pressure (SBP)
Time frame: 3 days of postoperatively
The minimum pressure recorded just prior to the next contraction.
Diastolic Blood pressure (DBP)
Time frame: 3 days of postoperatively
The maximum blood pressure during contraction of the ventricles.
Respiratory Rate (RR)
Time frame: 3 days of postoperatively
The number of breaths they take per minute.
Oxygen Saturation (SPO2)
Time frame: 3 days of postoperatively
A pulse oximeter reading that indicates what percentage of your blood is saturated.
Modified Borg Dyspnea Scale (MBDS)
Time frame: 3 days of postoperatively
A valid and reliable tool to measure the intensity of dyspnea. It is a categorical scale with ratio properties, rating from 0 to 10, 0 being not dyspneic at all and 10 being maximally dyspneic.
Pulmonary Function Test FVC
Time frame: 3 days of postoperatively
Noninvasive test that show how well the lungs are working, measuring of FVC
Pulmonary Function Test FEV
Time frame: 3 days of postoperatively
Noninvasive tests that show how well the lungs are working, measuring of FEV
Pulmonary Function Test FEV1/FVC
Time frame: 3 days of postoperatively
Noninvasive tests that show how well the lungs are working, measuring of FEV1/FVC
Pulmonary Function Test PEFR
Time frame: 3 days of postoperatively
Noninvasive tests that show how well the lungs are working, measuring of PEFR.
Activity and Mobility Promotion (AMP)
Time frame: 3 days of postoperatively
AMP is based on measuring increasing patient mobility during hospital stay. The initial goals of this program included mobilization of each patient 3 times per day, documentation of patient mobility levels on the AMP scale.
Visual Analogue Scale (VAS)
Time frame: 3 days of postoperatively
This measure is based on self-reported symptoms and is recorded with a single mark placed along a 10-cm line, which represents a continuum between "no pain" on the left end (0 cm) and "worst pain" on the right end. to determine the intensity of pain and its enhancement when coughing in the postoperative area.
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 6 May 2024.
- Background: PubMed 24155356Branson RD. The scientific basis for postoperative respiratory care. Respir Care. 2013 Nov;58(11):1974-84. doi: 10.4187/respcare.02832.
- Background: PubMed 28054356Moore JA, Conway DH, Thomas N, Cummings D, Atkinson D. Impact of a peri-operative quality improvement programme on postoperative pulmonary complications. Anaesthesia. 2017 Mar;72(3):317-327. doi: 10.1111/anae.13763. Epub 2017 Jan 4.
- Background: PubMed 19880838Smetana GW. Postoperative pulmonary complications: an update on risk assessment and reduction. Cleve Clin J Med. 2009 Nov;76 Suppl 4:S60-5. doi: 10.3949/ccjm.76.s4.10.
- Background: PubMed 32161042Odor PM, Bampoe S, Gilhooly D, Creagh-Brown B, Moonesinghe SR. Perioperative interventions for prevention of postoperative pulmonary complications: systematic review and meta-analysis. BMJ. 2020 Mar 11;368:m540. doi: 10.1136/bmj.m540.
- Background: PubMed 29367198Boden I, Skinner EH, Browning L, Reeve J, Anderson L, Hill C, Robertson IK, Story D, Denehy L. Preoperative physiotherapy for the prevention of respiratory complications after upper abdominal surgery: pragmatic, double blinded, multicentre randomised controlled trial. BMJ. 2018 Jan 24;360:j5916. doi: 10.1136/bmj.j5916.
- Background: PubMed 9118688Brooks-Brunn JA. Predictors of postoperative pulmonary complications following abdominal surgery. Chest. 1997 Mar;111(3):564-71. doi: 10.1378/chest.111.3.564.
- Background: PubMed 19099160Manzano RM, Carvalho CR, Saraiva-Romanholo BM, Vieira JE. Chest physiotherapy during immediate postoperative period among patients undergoing upper abdominal surgery: randomized clinical trial. Sao Paulo Med J. 2008 Sep;126(5):269-73. doi: 10.1590/s1516-31802008000500005.
- Background: PubMed 9393272Fagevik Olsen M, Hahn I, Nordgren S, Lonroth H, Lundholm K. Randomized controlled trial of prophylactic chest physiotherapy in major abdominal surgery. Br J Surg. 1997 Nov;84(11):1535-8. doi: 10.1111/j.1365-2168.1997.02828.x.
- Background: PubMed 10212115Siafakas NM, Mitrouska I, Bouros D, Georgopoulos D. Surgery and the respiratory muscles. Thorax. 1999 May;54(5):458-65. doi: 10.1136/thx.54.5.458. No abstract available.
- Background: PubMed 25058504Jammer I, Wickboldt N, Sander M, Smith A, Schultz MJ, Pelosi P, Leva B, Rhodes A, Hoeft A, Walder B, Chew MS, Pearse RM; European Society of Anaesthesiology (ESA) and the European Society of Intensive Care Medicine (ESICM); European Society of Anaesthesiology; European Society of Intensive Care Medicine. Standards for definitions and use of outcome measures for clinical effectiveness research in perioperative medicine: European Perioperative Clinical Outcome (EPCO) definitions: a statement from the ESA-ESICM joint taskforce on perioperative outcome measures. Eur J Anaesthesiol. 2015 Feb;32(2):88-105. doi: 10.1097/EJA.0000000000000118.
- Background: PubMed 21629603Cheifetz O, Lucy SD, Overend TJ, Crowe J. The effect of abdominal support on functional outcomes in patients following major abdominal surgery: a randomized controlled trial. Physiother Can. 2010 Summer;62(3):242-53. doi: 10.3138/physio.62.3.242. Epub 2010 Jul 23.
- Background: PubMed 19864881Smith PR, Baig MA, Brito V, Bader F, Bergman MI, Alfonso A. Postoperative pulmonary complications after laparotomy. Respiration. 2010;80(4):269-74. doi: 10.1159/000253881. Epub 2009 Oct 28.
- 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.
Feras M Tana, MSc principal investigator
Yeditepe University
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing I COUGH care program in people with Dyspnea and Pain, run by Yeditepe University at 3 sites in Libya.
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 3 inclusion and 11 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 6 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Libya. 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?
Heart Rate (HR) (time frame: 3 days of postoperatively). 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?
On the ClinicalTrials.gov record for NCT06255327, which also lists 54 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 6 May 2024.