- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06756555
Effect of Incentive Spirometry on Post-operative Pulmonary Complications After Bariatric Surgery
December 26, 2024 updated by: Muhammad Naveed Babur, Superior University
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.
Study Overview
Status
Active, not recruiting
Conditions
Intervention / Treatment
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 Type
Observational
Enrollment (Actual)
140
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Punjab
-
Lahore, Punjab, Pakistan
- Shalamar Hospital Mughalpura
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
No
Sampling Method
Probability Sample
Study Population
population included Complications After Bariatric Surgery to check the Effects of Incentive Spirometry on Post-operative Pulmonary
Description
Inclusion Criteria:
- 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)..
Exclusion Criteria:
- Patients weight below 25BMI.
- other abdominal surgeries.
- Patients having absence of teeth.
- Patients age below 18 years .
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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. |
12 Months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
February 15, 2024
Primary Completion (Actual)
August 1, 2024
Study Completion (Estimated)
March 1, 2025
Study Registration Dates
First Submitted
December 26, 2024
First Submitted That Met QC Criteria
December 26, 2024
First Posted (Actual)
March 25, 2025
Study Record Updates
Last Update Posted (Actual)
March 25, 2025
Last Update Submitted That Met QC Criteria
December 26, 2024
Last Verified
December 1, 2024
More Information
Terms related to this study
Other Study ID Numbers
- MSAHS/Batch-Spring23/019
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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