Bariatric Surgery CandidateNCT06756555
Effect of Incentive Spirometry on Post-operative Pulmonary Complications After Bariatric Surgery
An observational study of Bariatric Surgery Candidate, run by Superior University at 1 site in Pakistan.
Trial summary
Today, obesity is the major concern and obese patients are at higher risk of developing pulmonary complications. Incentive Spirometry is widely used worldwide to reduce rates of pulmonary complications. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Bariatric Surgery Candidate
- What is being tested?
- efficacy of Incentive spirometer
- How many people
- 140 participants
- Where
- 1 sitePakistan
- Study dates
- 15 Feb 2024to 1 Mar 2025
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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
Study population: population included Complications After Bariatric Surgery to check the Effects of Incentive Spirometry on Post-operative Pulmonary
Who may be able to join
- Patient having weight above 25 BMI
- Age between 18 years to 60 years
- having Post Operative pulmonary complication.
- Bariatric patients (Sleeve gastrectomy,Mini gastric Bypass,Sleeve gastrectomy to gastric bypass ,sleeve re do surgery)..
Who cannot join
- Patients weight below 25BMI.
- other abdominal surgeries.
- Patients having absence of teeth.
- Patients age below 18 years .
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Incentive Spirometry on Post Operative Pulmonary Complications After Bariatric Surgery: a Cross Sectional Study
Today, obesity is the major concern and obese patients are at higher risk of developing pulmonary complications. Incentive Spirometry is widely used worldwide to reduce rates of pulmonary complications. In this study, Effect of Incentive Spirometry (IS) on Post Operative Bariatric Patients (Male and Female) will be studied on patients about sample size of 140 including male and female gender, BMI above 30 kg/m2 having Post Operative Bariatric Surgeries with chances of generating Pulmonary complications.
Read the detailed description
Research will be conducted in Shalamar Hospital Lahore and data will be collected through predesigned proforma. In previous studies some studies show positive and but some studies don't recommend Incentive Spirometry as a post operative Rehabilitation therapy.But this therapy device is still used in present days in Post Operative patients to prevent pulmonary complications. In this study we conclude the positive or negative effect of Incentive Spirometry.
- Conditions
- Bariatric Surgery Candidate
- Being tested
- efficacy of Incentive spirometer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
efficacy of Incentive spirometerDiagnostic test
The main objective of this research is to check the efficacy of Incentive spirometer on pulmonary complication after bariatric surgrey
What is being measured
The primary outcome is the main question the study is designed to answer.
Respiratory rate using Spirometry
Rrespiratory rate, assessed using manual or electronic monitoring, and patient satisfaction with incentive spirometry, evaluated through a structured questionnaire focusing on ease of use and perceived benefits.
Average values in healthy patients aged 20-60 range from 5.5 to 4.75 liters in males and from 3.75 to 3.25 liters in females.
Measured: 12 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jan 2025
- Study start15 Feb 2024
- Primary completion1 Aug 2024
- Study completion1 Mar 2025 (estimated)
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 Superior 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
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 140 participants (actual)
Sponsor and investigators
- Lead sponsor
- Superior University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Muhammad Naveed Babur, Superior University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06756555
- Sponsor's protocol ID
- MSAHS/Batch-Spring23/019
- Status last verified
- Dec 2024
- First submitted
- 26 Dec 2024
- Last updated
- 3 Jan 2025
- 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 3 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Incentive Spirometry on Post Operative Pulmonary Complications After Bariatric Surgery: a Cross Sectional Study
- ClinicalTrials.gov ID
- NCT06756555
- Acronym / sponsor ID
- MSAHS/Batch-Spring23/019
- Conditions
- Bariatric Surgery Candidate
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 140 participants (actual)
- Lead sponsor
- Superior UniversityUniversity, hospital or other
- Study start
- 15 Feb 2024 (actual)
- Primary completion
- 1 Aug 2024 (actual)
- Study completion
- 1 Mar 2025 (estimated)
- First posted
- 3 Jan 2025 (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.
Today, obesity is the major concern and obese patients are at higher risk of developing pulmonary complications. Incentive Spirometry is widely used worldwide to reduce rates of pulmonary complications. In this study, Effect of Incentive Spirometry (IS) on Post Operative Bariatric Patients (Male and Female) will be studied on patients about sample size of 140 including male and female gender, BMI above 30 kg/m2 having Post Operative Bariatric Surgeries with chances of generating Pulmonary complications.
Detailed description
Research will be conducted in Shalamar Hospital Lahore and data will be collected through predesigned proforma. In previous studies some studies show positive and but some studies don't recommend Incentive Spirometry as a post operative Rehabilitation therapy.But this therapy device is still used in present days in Post Operative patients to prevent pulmonary complications. In this study we conclude the positive or negative effect of Incentive Spirometry.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- population included Complications After Bariatric Surgery to check the Effects of Incentive Spirometry on Post-operative Pulmonary
Key inclusion criteria (4 listed)
- Patient having weight above 25 BMI
- Age between 18 years to 60 years
- having Post Operative pulmonary complication.
- Bariatric patients (Sleeve gastrectomy,Mini gastric Bypass,Sleeve gastrectomy to gastric bypass ,sleeve re do surgery)..
Key exclusion criteria (4 listed)
- Patients weight below 25BMI.
- other abdominal surgeries.
- Patients having absence of teeth.
- Patients age below 18 years .
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 |
|---|---|---|
| efficacy of Incentive spirometerThe main objective of this research is to check the efficacy of Incentive spirometer on pulmonary complication after bariatric surgrey | Diagnostic test | – |
Primary outcome
Respiratory rate using Spirometry
Time frame: 12 Months
Rrespiratory rate, assessed using manual or electronic monitoring, and patient satisfaction with incentive spirometry, evaluated through a structured questionnaire focusing on ease of use and perceived benefits. Average values in healthy patients aged 20-60 range from 5.5 to 4.75 liters in males and from 3.75 to 3.25 liters in females.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jan 2025.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Bariatric Surgery Candidate, run by Superior 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 4 inclusion and 4 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: under way, not looking for participants, as of the sponsor's last update on 3 Jan 2025. 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?
This study is still under way. Results are not available in the source record yet.
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?
Respiratory rate using Spirometry (time frame: 12 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 3 Jan 2025.