Pulmonary ComplicationsNCT04700215
Comparison of BiPAP and ٰIS in Reducing Post CABG Pulmonary Complications
A study testing BiPAP and Incentive spirometry in people with Pulmonary Complications, run by Chaudhry Pervaiz Elahi Institute of Cardiology at 1 site in Pakistan.
Trial summary
To evaluate the effect of Bi-level Positive Airway Pressure (BiPAP) and Incentive Spirometry (IS) in post CABG patients. Read more about this study
- Who is it for?
- Ages 20 to 60 years
- Conditions the study is for
- Pulmonary Complications
- What is being tested?
- BiPAP and Incentive spirometry
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 350 participants
- Where
- 1 sitePakistan
- Study dates
- 1 Mar 2021to 30 Aug 2022
- 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 20 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- CABG patients
- Patient willing to study
- Patients planned for on-pump cardiac surgical procedures
- Both genders (Male \& Female)
- Age 20-60 years
- Ejection fraction 40-60%
Who cannot join
- Patients with valvular lesions
- Off-pump cardiac surgery
- Refusal to give consent for BiPAP
- Emergency surgery
- Previous cardiac surgery
- Obesity BMI>30
- ASA status V
Trial locations and contacts
1 site in 1 country.
Pakistan1 site, 1 recruiting
- Recruiting
CPEIC
Multan Khurd, Punjab Province, 66000
Muhammad Imran Khan, MBBS, +923326366121, imrkhan803@gmail.com
About this study
Official title: Comparison of Effectiveness of Bilevel Positive Airway Pressure and Incentive Spirometry in Reducing Post CABG Surgery Pulmonary Complications
To evaluate the effect of Bi-level Positive Airway Pressure (BiPAP) and Incentive Spirometry (IS) in post CABG patients.
Read the detailed description
As postoperative pulmonary complications are major concern in cardiac surgery patients and our local data is deficient for making better management guidelines. My study aims to provide a base for future research on this dimension and to decide better management plan for post cardiac surgical pulmonary complications. The hypothesis is Post extubation BiPAP is more effective than Incentive Spirometry (IS) in reducing postoperative pulmonary complications in cardiac surgical patients and the purpose of the study is to evaluate the effect of Bi-level Positive Airway Pressure (BiPAP) and Incentive Spirometry (IS) in cardiac surgical patients.
This Randomized Controlled Trial (RCT) study will be conducted at Chaudhary pervaiz elahi institute of cardiology ICU multan.
A sample size of 350 patients will be taken and effect of BiPAP and Incentive spirometry will be studied in reducing pulmonary complications post CABG surgery. Data will be analyzed through SPSS. For quantitative variables, mean and standard deviation will be calculated and for qualitative variables, frequency and percentage will be calculated. Chi square test will be used to estimate association between qualitative variables. A p value < 0.05 will be significant.
- Conditions
- Pulmonary Complications
- Being tested
- BiPAP, Incentive spirometry
- Keywords
- CABG, BiPAP, IS
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BiPAPDevice
Also called Bilevel
To give bilevel positive airway pressure to the lungs
Incentive spirometryDevice
IS for 15 minutes after every 4 hours
| Study group | Role | What they receive |
|---|---|---|
| Group 01 Effectiveness of BiPAP in reducing post CABG pulmonary complications | Active comparator | Bilevel positive airway pressure device after every 6 hours Receives: Device: BiPAP |
| Group 02 Effectiveness of IS in reducing post CABG pulmonary complications | Active comparator | Incentive spirometry for 15 minutes after every 4 hours Receives: Device: Incentive spirometry |
What is being measured
The primary outcome is the main question the study is designed to answer.
Post CABG pulmonary complications
To see the effect of BiPAP and IS in reducing post CABG pulmonary complications
Measured: 06 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jan 2021
- Study start1 Mar 2021
- Primary completion20 Jun 2022 (estimated)
- Study completion30 Aug 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pulmonary ComplicationsStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Care provider, Outcomes assessor
- Enrolment
- 350 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chaudhry Pervaiz Elahi Institute of Cardiology
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Muhammad Imran Khan, Chaudhry Pervaiz Elahi Institute of Cardiology
- Investigators
- Muhammad Imran Khan, MBBS, Principal investigator, Chaudhry Pervaiz Elahi Institute of Cardiology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04700215
- Sponsor's protocol ID
- No.01-2020/ED/CPEIC/MULTAN
- Status last verified
- Mar 2022
- First submitted
- 6 Jan 2021
- Last updated
- 9 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
- 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 9 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Effectiveness of Bilevel Positive Airway Pressure and Incentive Spirometry in Reducing Post CABG Surgery Pulmonary Complications
- ClinicalTrials.gov ID
- NCT04700215
- Acronym / sponsor ID
- No.01-2020/ED/CPEIC/MULTAN
- Conditions
- Pulmonary Complications
- Keywords
- CABG, BiPAP, IS
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 350 participants (estimated)
- Lead sponsor
- Chaudhry Pervaiz Elahi Institute of CardiologyOther government
- Study start
- 1 Mar 2021 (actual)
- Primary completion
- 20 Jun 2022 (estimated)
- Study completion
- 30 Aug 2022 (estimated)
- First posted
- 7 Jan 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.
To evaluate the effect of Bi-level Positive Airway Pressure (BiPAP) and Incentive Spirometry (IS) in post CABG patients.
Detailed description
As postoperative pulmonary complications are major concern in cardiac surgery patients and our local data is deficient for making better management guidelines. My study aims to provide a base for future research on this dimension and to decide better management plan for post cardiac surgical pulmonary complications. The hypothesis is Post extubation BiPAP is more effective than Incentive Spirometry (IS) in reducing postoperative pulmonary complications in cardiac surgical patients and the purpose of the study is to evaluate the effect of Bi-level Positive Airway Pressure (BiPAP) and Incentive Spirometry (IS) in cardiac surgical patients.
This Randomized Controlled Trial (RCT) study will be conducted at Chaudhary pervaiz elahi institute of cardiology ICU multan.
A sample size of 350 patients will be taken and effect of BiPAP and Incentive spirometry will be studied in reducing pulmonary complications post CABG surgery. Data will be analyzed through SPSS. For quantitative variables, mean and standard deviation will be calculated and for qualitative variables, frequency and percentage will be calculated. Chi square test will be used to estimate association between qualitative variables. A p value < 0.05 will be significant.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 01 Effectiveness of BiPAP in reducing post CABG pulmonary complications | Active comparator | Device: BiPAPBilevel positive airway pressure device after every 6 hours |
| Group 02 Effectiveness of IS in reducing post CABG pulmonary complications | Active comparator | Device: Incentive spirometryIncentive spirometry for 15 minutes after every 4 hours |
Who may qualify
- Ages
- 20 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- CABG patients
- Patient willing to study
- Patients planned for on-pump cardiac surgical procedures
- Both genders (Male \& Female)
- Age 20-60 years
Key exclusion criteria (7 listed)
- Patients with valvular lesions
- Off-pump cardiac surgery
- Refusal to give consent for BiPAP
- Emergency surgery
- Previous cardiac surgery
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 |
|---|---|---|
| BiPAPAlso: BilevelTo give bilevel positive airway pressure to the lungs | Device | Group 01 Effectiveness of BiPAP in reducing post CABG pulmonary complications |
| Incentive spirometryIS for 15 minutes after every 4 hours | Device | Group 02 Effectiveness of IS in reducing post CABG pulmonary complications |
Primary outcome
Post CABG pulmonary complications
Time frame: 06 months
To see the effect of BiPAP and IS in reducing post CABG pulmonary complications
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Mar 2022.
- 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.
Muhammad Imran Khan, MBBS principal investigator
Chaudhry Pervaiz Elahi Institute of Cardiology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing BiPAP and Incentive spirometry in people with Pulmonary Complications, run by Chaudhry Pervaiz Elahi Institute of Cardiology 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 6 inclusion and 7 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 9 Mar 2022. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Muhammad Imran Khan (+923326366121, imrkhan803@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Post CABG pulmonary complications (time frame: 06 months). 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 9 Mar 2022.