Effect of Individualized PEEP on Postoperative Pulmonary Complication in Bariatrics

NCT06168162 | Recruiting DMC

• 1 other identifier: FMASU MD259/2023
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

Ventilation with low tidal volume and high PEEP (positive end expiratory pressure) has been shown to improve oxygenation in patients with ARDS (acute respiratory distress syndrome). In obese patients undergoing laparoscopic bariatric surgeries, the risk of postoperative pulmonary complications (PPCs) increases significantly with general anesthesia. Previous studies have shown that protective lung ventilation strategies could improve intraoperative oxygenation and lung mechanics. In this study would compare the effect of optimum individualized high PEEP versus standard PEEP - on postoperative pulmonary complications

Conditions

Mechanical Ventilation Pressure High; Bariatric Surgery Candidate

Keywords

ventilation

Outcome Measures

Primary Outcomes (1)

• postoperative pulmonary complication

  pneumonia-atelactasis-bronchospasm-respiratory failure

  postoperative 10 days after surgery

Secondary Outcomes (1)

• Pulmonary functions test

  postoperative 1st , 3rd and 5th day

Study Arms (2)

titrate PEEP

EXPERIMENTAL

individulaized PEEP starting 7cmH2O titrated to best static compliance (Cstat) ranging from 50 -100 cmH2O

Other: titated PEEP to best static compliance

standard

ACTIVE COMPARATOR

standard PEEP of 5 cmH2O

Other: titated PEEP to best static compliance

Interventions

titated PEEP to best static compliance OTHER

the Intraoperative PEEP will be titrated to best static compliance for each patient

standard; titrate PEEP

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients were eligible for participation if the met the following criteria
• Age between 18 and 60 years old.
• Body mass index \> 40
• Laparoscopic bariatric elective surgery under general anesthesia.
• ARISCAT (Assess Respiratory Risk in Surgical Patients in Catalonia) score ≥ 45 . ARISCAT score is a clinically practical seven-factor scoring system to assess the risk of a composite PPC.

You may not qualify if:

• Previous lung surgery
• ASA status III or IV.
• Moderate to severe obstructive or restrictive lung disease .
• Persistant intraoperative hemodynamic instability .
• Need for postoperative mechanical ventilation

Sponsors & Collaborators

• Ain Shams University: lead

Study Sites (1)

Ain shams university

Cairo, Cairo Governorate, Egypt

RECRUITING

MeSH Terms

Conditions

Respiratory Aspiration

Condition Hierarchy (Ancestors)

Respiration Disorders; Respiratory Tract Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

wessam selima, MD

CONTACT

+201001958858; w.z.selima@med.asu.edu.eg

ghada sharafeldin, MSc

CONTACT

+201159296642; ghadasharaf.92@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 4, 2023
• First Posted: December 13, 2023
• Study Start: October 1, 2023
• Primary Completion: April 1, 2025
• Study Completion: May 1, 2025
• Last Updated: February 17, 2025

Record last verified: 2025-01

Locations

EG (1)