Lung Ultrasound Versus Dynamic Lung Compliance to Detect the Optimum PEEP After Alveolar Recruitment for Patients Undergoing Laparoscopic Gastric Sleeve Surgery

Lung Ultrasound Versus Dynamic Lung Compliance to Detect the Optimum PEEP After Alveolar Recruitment for Patients Undergoing Laparoscopic Gastric Sleeve Surgery, Randomized Clinical Trial

The aim of this study is to evaluate The role of transthoracic lung US as a clinical tool in Comparison to dynamic lung compliance for detection of optimum PEEP for obese patients undergoing laparoscopic gastric sleeve surgery.

Study Overview

• Status: Completed
• Conditions: Mechanical Ventilation During Anesthesia
• Intervention / Treatment: Device: anesthesia ventilator machine; Device: lung ultrasound

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Cairo, Egypt
    • Ain Shams University Hospitals

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• physical status American Society of Anesthesiologist(ASA) I or II

Exclusion Criteria:

• Patients refuse ASA physical status more > II
• Patients with pre-existing significant pulmonary disease with abnormalities in spirometry, previous lung surgery, home oxygen therapy and significant cardiac dysfunction.
• Patients with pulmonary hypertension.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: dynamic lung compliance for detection of optimum PEEP; detection of optimum PEEP by measurement of the dynamic lung compliance (by the ventilator machine) after lung recruitment	Device: anesthesia ventilator machine; dynamic lung compliance measurements will be used for detection of the optimum PEEP after alveolar recruitment
Active Comparator: Lung ultrasound for detection of the optimum PEEP; Lung ultrasound will be used to detect the optimum PEEP after lung recruitment	Device: lung ultrasound; lung ultrasound views will be used for detection of the optimum PEEP after alveolar recruitment

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
detection of the optimum PEEP which is measured in mmHg	the optimum PEEP will be detected after alveolar recruitment either by dynamic lung compliance or by lung ultarsound views	intraoperative period

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
prevention of postoperative pulmonary complications	patients will be monitored for detection of postoperative pulmonary complictaios as atelectasis , pneumothorax , respiratory failure	1st 24 hour

Collaborators and Investigators

• Sponsor: Ain Shams University

Study record dates

Study Major Dates

• Study Start (Actual): December 16, 2020
• Primary Completion (Actual): January 15, 2022
• Study Completion (Actual): January 20, 2022

Study Registration Dates

• First Submitted: January 7, 2021
• First Submitted That Met QC Criteria: January 8, 2021
• First Posted (Actual): January 11, 2021

Study Record Updates

• Last Update Posted (Actual): July 8, 2022
• Last Update Submitted That Met QC Criteria: July 7, 2022
• Last Verified: July 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Central Nervous System Depressants; Anesthetics
• Other Study ID Numbers: FMASU R 127/2020

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No