Post-cardiac SurgeryNCT05044559
Continuous Positive Air Way Pressure in Cardiac Rehabilitation After CABG
A study testing Continuous Positive Air Way Group in people with Post-cardiac Surgery, run by Riphah International University at 1 site in Pakistan.
Trial summary
Different studies reported that CPAP is effective to prevent respiratory complication in post CABG patient and have greater impact on walking time, ventilatory function and breathing pattern. Read more about this study
- Who is it for?
- Ages 35 to 65 years, men only
- Conditions the study is for
- Post-cardiac Surgery
- What is being tested?
- Continuous Positive Air Way Group
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 38 participants
- Where
- 1 sitePakistan
- Study dates
- 15 Jul 2019to 27 Feb 2020
- 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 35 to 65 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- age between 35 to 60 years.
- With a clinical diagnosis of coronary artery disease, underwent elective CABG (Acute)
Who cannot join
- Low ejection friction (15%)
- Patient those who have any arrhythmias
- Unstable angina
- Patient having pace maker and implantable cardioverter defibrillator
- COPD and asthmatic patient
- Patient having BMI more then 40
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Continuous Positive Airway Pressure in Phase 1 Cardiac Rehabilitation After Post CABG
Different studies reported that CPAP is effective to prevent respiratory complication in post CABG patient and have greater impact on walking time, ventilatory function and breathing pattern.
Read the detailed description
The walking time (6 minute walk test), effect on arterial blood gasses and long term effects of CPAP on cardiac activity, the previous studies focus only on the acute effects of CPAP along with specific exercises but did not tell about the long term effects. based on these finding this study is design to assess the effectiveness of CPAP in Post-op CABG patients regarding there early mobilization, walking time, ABGs and Ejection Fraction as there prognostic parameters in both phase-1 cardiac rehabilitation within hospital as well as in long-term prognosis, is of great interest.
- Conditions
- Post-cardiac Surgery
- Being tested
- Continuous Positive Air Way Group, Control Group
- Keywords
- Continuous Positive Airway Pressure, Coronary Artery Bypass Graft Surgery, Inpatients Rehabilitations
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Continuous Positive Air Way GroupOther
CPAP between 10 and 12 cmH2O
Control GroupOther
Day 1: Bed mobility chest physiotherapy, active assistive ROM 5 repetitions of upper and lower limb, ACBT cycle. ABGS was analyses at first minute of exercise and vital was record after exercise.
Day 2: Active range of motion exercise progress with 5 repetitions bed to chair mobility. same exercise progress with 5 repetition and 5 minute walk( day 3rd ).walking time will increase with 10 min at 4 day and at 5th day stair climbing the ABGS was record in ICU 3 days.
| Study group | Role | What they receive |
|---|---|---|
| Continuous Positive Air Way Group | Experimental | Day 1: Use of CPAP between 10 and 12 cmH2O according to tolerance for 20 minutes two time a day at first day of post surgery bed mobility chest physiotherapy ,active assistive ROM 5 repetitions of upper and lower limb, ACBT cycle. ABGS was analyses at first minute of exercise. and vital was record after exercise.
Day 2: Active ROM exercise progress of 5 repetitions bed to chair mobility. same exercise progress with 5 repetition and 5 minute walk( day 3rd ).walking time was increase with 10 min at 4 day and at 5th day stair climbing the ABGS was record in ICU 3 days. Receives: Other: Continuous Positive Air Way Group |
| Control Group | Active comparator | Day 1: Bed mobility chest physiotherapy, active assistive ROM 5 repetitions of upper and lower limb, ACBT cycle. ABGS was analyses at first minute of exercise and vital was record after exercise.
Day 2: Active range of motion exercise progress with 5 repetitions bed to chair mobility. same exercise progress with 5 repetition and 5 minute walk( day 3rd ).walking time will increase with 10 min at 4 day and at 5th day stair climbing the ABGS was record in ICU 3 days. Receives: Other: Control Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Arterial Blood Gasses
measures oxygen and carbon dioxide levels in your blood. It also measures your body's acid-base (pH) level, which is normally balanced when you are healthy.
Measured: 3 days
Secondary outcomes (3)
6 minute walk test
gold standard test to measure exercise capacity and requires less physical space and allows for easier monitoring of vital parameters
Measured: 3 days
Ejection Fraction
expressed as a percentage, of how much blood the left ventricle pumps out with each contraction.
Measured: 4 week
Short Form 12 Questionnaire
measuring tool for mental and physical health components. It consists of 12 questions which cover the eight health domain with one or two question per domain
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2021
- Study start15 Jul 2019
- Primary completion27 Feb 2020
- Study completion27 Feb 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post-cardiac SurgeryStudies of the same condition, open and under way.
- More trials run by Riphah International UniversityThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 38 participants (actual)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sumaiyah Obaid, MS, Principal investigator, Riphah International University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05044559
- Sponsor's protocol ID
- REC/00593 Memoona Salal
- Status last verified
- Sep 2021
- First submitted
- 13 Sep 2021
- Last updated
- 21 Sep 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 21 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Continuous Positive Airway Pressure in Phase 1 Cardiac Rehabilitation After Post CABG
- ClinicalTrials.gov ID
- NCT05044559
- Acronym / sponsor ID
- REC/00593 Memoona Salal
- Conditions
- Post-cardiac Surgery
- Keywords
- Continuous Positive Airway Pressure, Coronary Artery Bypass Graft Surgery, Inpatients Rehabilitations
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 38 participants (actual)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 15 Jul 2019 (actual)
- Primary completion
- 27 Feb 2020 (actual)
- Study completion
- 27 Feb 2020 (actual)
- First posted
- 14 Sep 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.
Different studies reported that CPAP is effective to prevent respiratory complication in post CABG patient and have greater impact on walking time, ventilatory function and breathing pattern.
Detailed description
The walking time (6 minute walk test), effect on arterial blood gasses and long term effects of CPAP on cardiac activity, the previous studies focus only on the acute effects of CPAP along with specific exercises but did not tell about the long term effects. based on these finding this study is design to assess the effectiveness of CPAP in Post-op CABG patients regarding there early mobilization, walking time, ABGs and Ejection Fraction as there prognostic parameters in both phase-1 cardiac rehabilitation within hospital as well as in long-term prognosis, is of great interest.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Continuous Positive Air Way Group | Experimental | Other: Continuous Positive Air Way GroupDay 1: Use of CPAP between 10 and 12 cmH2O according to tolerance for 20 minutes two time a day at first day of post surgery bed mobility chest physiotherapy ,active assistive ROM 5 repetitions of upper and lower limb, ACBT cycle. ABGS was analyses at first minute of exercise. and vital was record after exercise. Day 2: Active ROM exercise progress of 5 repetitions bed to chair mobility. same exercise progress with 5 repetition and 5 minute walk( day 3rd ).walking time was increase with 10 min at 4 day and at 5th day stair climbing the ABGS was record in ICU 3 days. |
| Control Group | Active comparator | Other: Control GroupDay 1: Bed mobility chest physiotherapy, active assistive ROM 5 repetitions of upper and lower limb, ACBT cycle. ABGS was analyses at first minute of exercise and vital was record after exercise. Day 2: Active range of motion exercise progress with 5 repetitions bed to chair mobility. same exercise progress with 5 repetition and 5 minute walk( day 3rd ).walking time will increase with 10 min at 4 day and at 5th day stair climbing the ABGS was record in ICU 3 days. |
Who may qualify
- Ages
- 35 to 65 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- age between 35 to 60 years.
- With a clinical diagnosis of coronary artery disease, underwent elective CABG (Acute)
Key exclusion criteria (6 listed)
- Low ejection friction (15%)
- Patient those who have any arrhythmias
- Unstable angina
- Patient having pace maker and implantable cardioverter defibrillator
- COPD and asthmatic patient
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 |
|---|---|---|
| Continuous Positive Air Way GroupCPAP between 10 and 12 cmH2O | Other | Continuous Positive Air Way Group |
| Control GroupDay 1: Bed mobility chest physiotherapy, active assistive ROM 5 repetitions of upper and lower limb, ACBT cycle. ABGS was analyses at first minute of exercise and vital was record after exercise. Day 2: Active range of motion exercise progress with 5 repetitions bed to chair mobility. same exercise progress with 5 repetition and 5 minute walk( day 3rd ).walking time will increase with 10 min at 4 day and at 5th day stair climbing the ABGS was record in ICU 3 days. | Other | Control Group |
Primary outcome
Arterial Blood Gasses
Time frame: 3 days
measures oxygen and carbon dioxide levels in your blood. It also measures your body's acid-base (pH) level, which is normally balanced when you are healthy.
3 secondary outcomes
6 minute walk test
Time frame: 3 days
Ejection Fraction
Time frame: 4 week
Short Form 12 Questionnaire
Time frame: 4 weeks
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 21 Sep 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.
Sumaiyah Obaid, MS principal investigator
Riphah International University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Continuous Positive Air Way Group in people with Post-cardiac Surgery, run by Riphah International University at 1 site in Pakistan.
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 2 inclusion and 6 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 21 Sep 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 Pakistan. 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?
Arterial Blood Gasses (time frame: 3 days). 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 21 Sep 2021; AzTrials last refreshed its copy on 8 Nov 2026.