Intraoperative Peak Airway Pressure Changes on Postoperative Pulmonary Function After Muscle Plication

April 27, 2024 updated by: Neveen Abd El Maksoad Kohaf, Al-Azhar University

Effects of Intraoperative Peak Airway Pressure Changes on Postoperative Pulmonary Function After Muscle Plication in Abdominoplasty Operations: A Randomized Double-Blind Trial

An abdominal panniculus excision procedure is known as an abdominoplasty (panniculectomy). Musculofascial plication is a crucial aspect of abdominoplasty, especially for patients with significant divarication of the recti muscles. This study aimed to evaluate the effect of intraoperative changes in peak airway pressure (PAP) after muscle plication on postoperative pulmonary function.

Study Overview

Status

Recruiting

Conditions

Detailed Description

Musculofascial plication is a crucial aspect of abdominoplasty, especially for patients with significant divarication of the recti muscles. This surgical procedure involves the removal of surplus skin and fat around the abdomen, known as panneculectomy, and the anterior abdominal wall muscles' laxity being tightened. This study aimed to elucidate the effect of intraoperative changes in PAP after muscle plication on postoperative pulmonary function.

Study Type

Observational

Enrollment (Estimated)

120

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Egypt
      • Tanta, Egypt, 11865
        • Recruiting
        • Neveen Kohaf
        • Principal Investigator:
          • Haney Bauiomy
        • Principal Investigator:
          • Ahmed Abosakaya

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

age ranged between 20 and 50 years old,- American Society of Anesthesiologists (ASA) physical status classification I and came for abdominoplasty operation

Description

Inclusion Criteria:

  • age ranged between 20 and 50 years old,
  • American Society of Anesthesiologists (ASA) physical status classification I
  • came for abdominoplasty operation

Exclusion Criteria:

  • anemia or hemoglobin levels below 11g/dl
  • bleeding problems
  • cardiovascular disorders
  • restrictive and obstructive respiratory disease
  • abdominoplasty without plication.

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
Intraoperative peak airway pressure (PAP)
Time Frame: 4 hours
Intraoperative peak airway pressure (PAP) will be observed Pre-plication, Post- plication in supine position and Post- plication in semi-sitting position
4 hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Duration of oxygen therapy
Time Frame: 1 week
The duration of oxygen therapy will be recorded
1 week
Post operative Tidal Volume (Vt) (Measured by spirometer)
Time Frame: 24 hours postoperatively
The post operative Tidal Volume (Vt) will be measured by spirometer and will be recorded
24 hours postoperatively
Post operative Respiratory Rate (RR)
Time Frame: 24 hours postoperatively
The Post operative Respiratory Rate (RR) will be recorded
24 hours postoperatively
Hospital stay.
Time Frame: 1 week
The Duration of hospital stay will be recorded
1 week

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Al-Azhar University

Collaborators

Benha University

Investigators

  • Principal Investigator: Neveen Kohaf, ph.d, Al-Azhar University

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)

March 10, 2024

Primary Completion (Estimated)

May 15, 2024

Study Completion (Estimated)

May 15, 2024

Study Registration Dates

First Submitted

February 26, 2024

First Submitted That Met QC Criteria

February 26, 2024

First Posted (Actual)

March 4, 2024

Study Record Updates

Last Update Posted (Estimated)

April 30, 2024

Last Update Submitted That Met QC Criteria

April 27, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RC.2.8.2023

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Data will be shared upon resealable request from principle investigator

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP

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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