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NCT06291389 Clinical Trial

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

Abdominal Compartment Syndrome Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT06291389
Other study ID # RC.2.8.2023
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date March 10, 2024
Est. completion date May 15, 2024

Study information
Verified date April 2024
Source Al-Azhar University
Contact Neveen Kohaf, Ph.D
Phone +201060383012
Email nevenabdo@azhar.edu.eg
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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.

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.

Recruitment information / eligibility
Status Recruiting
Enrollment 120
Est. completion date May 15, 2024
Est. primary completion date May 15, 2024
Accepts healthy volunteers No
Gender All
Age group 20 Years to 50 Years
Eligibility 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 Design

Related Conditions & MeSH terms

Locations
Country Name City State
Egypt Neveen Kohaf Tanta

Sponsors (2)
Lead Sponsor Collaborator
Al-Azhar University Benha University

Country where clinical trial is conducted

Egypt, 

Outcome
Type Measure Description Time frame Safety issue
Primary Intraoperative peak airway pressure (PAP) 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 Duration of oxygen therapy The duration of oxygen therapy will be recorded 1 week
Secondary Post operative Tidal Volume (Vt) (Measured by spirometer) The post operative Tidal Volume (Vt) will be measured by spirometer and will be recorded 24 hours postoperatively
Secondary Post operative Respiratory Rate (RR) The Post operative Respiratory Rate (RR) will be recorded 24 hours postoperatively
Secondary Hospital stay. The Duration of hospital stay will be recorded 1 week
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