NCT06756555

Brief 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. 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.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
140

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Feb 2024

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 15, 2024

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2024

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

December 26, 2024

Completed
8 days until next milestone

First Posted

Study publicly available on registry

January 3, 2025

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2025

Completed
Last Updated

January 3, 2025

Status Verified

December 1, 2024

Enrollment Period

6 months

First QC Date

December 26, 2024

Last Update Submit

December 26, 2024

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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.

    12 Months

Interventions

The main objective of this research is to check the efficacy of Incentive spirometer on pulmonary complication after bariatric surgrey

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodProbability Sample
Study Population

population included Complications After Bariatric Surgery to check the Effects of Incentive Spirometry on Post-operative Pulmonary

You may qualify if:

  • 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)..

You may not qualify if:

  • Patients weight below 25BMI.
  • other abdominal surgeries.
  • Patients having absence of teeth.
  • Patients age below 18 years .

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Shalamar Hospital Mughalpura

Lahore, Punjab Province, Pakistan

Location

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

December 26, 2024

First Posted

January 3, 2025

Study Start

February 15, 2024

Primary Completion

August 1, 2024

Study Completion

March 1, 2025

Last Updated

January 3, 2025

Record last verified: 2024-12

Data Sharing

IPD Sharing
Will not share

Locations