Effect of Individualized PEEP on Postoperative Pulmonary Complication in Bariatrics

Bariatric Surgery Candidate Clinical Trial

Official title:

Effect of Individualized High Positive End-expiratory Pressure on Postoperative Pulmonary Rate in Laparoscopic Bariatric Surgeries

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06168162
• Other study ID #: FMASU MD259/2023
• Status: Recruiting
• Phase: N/A
• Start date: October 1, 2023
• Est. completion date: January 2025

Study information

• Verified date: November 2023
• Source: Ain Shams University
• Contact: wessam selima, MD
• Phone: +201001958858
• Email: w.z.selima[@]med.asu.edu.eg
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: January 2025
• Est. primary completion date: September 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 16 Years and older

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Bariatric Surgery Candidate
• Mechanical Ventilation Pressure High

Intervention

Other:
• titated PEEP to best static compliance
the Intraoperative PEEP will be titrated to best static compliance for each patient

Locations

Country	Name	City	State
Egypt	Ain shams university	Cairo	???????

Sponsors (1)

Lead Sponsor	Collaborator
Ain Shams University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	postoperative pulmonary complication	pneumonia-atelactasis-bronchospasm-respiratory failure	postoperative 10 days after surgery
Secondary	Pulmonary functions test	This test includes these values :FVC (forced vital capacity ) FEV1( forced expiratory volume in one sec ) FEV1% and FVC%	postoperative 1st , 3rd and 5th day