Alveolar Recruitment Maneuvers on Reduction of Lung Atelectasis in Bariatric Surgery by Using Lung Ultrasound Score

NCT05720351 | Unknown

• 1 other identifier: 35292\2\22
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

The study aims to compare the staircase alveolar recruitment maneuver with PEEP titration versus sustained inflation alveolar recruitment maneuver by using lung ultrasound score as an indicator of improving lung atelectasis in bariatric surgery

Conditions

Alveolar Recruitment Maneuvers; Atelectasis; Bariatric Surgery

Outcome Measures

Primary Outcomes (1)

• Improvement of Lung ultrasound score.

  Access lung ultrasound score at the end of surgery

  48 hours postoperatively

Secondary Outcomes (3)

• Access Pulmonary complications

  48 hours postoperatively

• Access incidence of oxygen desaturation

  48 hours Postoperatively

• Access Complications of recruitment maneuver

  48 hours Postoperatively

Study Arms (2)

Lachmann maneuver

ACTIVE COMPARATOR

Patients undergone the Lachmann recruitment maneuver (30 CmH2O PEEP for 30 seconds)

Procedure: Lachmann maneuver

Staircase maneuver

ACTIVE COMPARATOR

Patients undergone staircase recruitment maneuver (stepped increase in PEEP by 2 CmH2O every five breaths until reach upper deflection point

Procedure: Staircase maneuver

Interventions

Lachmann maneuver PROCEDURE

Patients undergone the Lachmann recruitment maneuver (30 CmH2O PEEP for 30 seconds)

Lachmann maneuver

Staircase maneuver PROCEDURE

Patients undergone Undergone staircase recruitment maneuver (stepped increase in PEEP by 2 CmH2O every five breaths until reach upper deflection point

Staircase maneuver

Eligibility Criteria

• Age: 21 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult morbidly obese patients (Body mass index \< 40kg / m2 or Body mass index \< 35kg / m2 with obesity-related comorbidities such as hypertension, diabetes, and sleep apnea)
• undergo elective bariatric laparoscopic surgery with an expected duration of at least one hour under general anesthesia.

You may not qualify if:

• Patient refusal to participate in the study.
• Patients with a previous history of thoracic surgery.
• Patients with a history of chest disease (COPD, emphysema, or pneumothorax).
• Patients with abnormal pre-operative chest radiographs such as pneumonia, pleural effusion.
• Patients with heart failure or impending failure.
• Patients with known hypovolemia.
• Patients with increased intracranial pressure.

Sponsors & Collaborators

• Tanta University: lead

Study Sites (1)

Alaa Mohsen Shahien

Tanta, ElGharbiaa, 31511, Egypt

Location

MeSH Terms

Conditions

Pulmonary Atelectasis

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases

Central Study Contacts

Alaa M Shahien, MD

CONTACT

+201555957744; alaa162094_pg@med.tanta.edu.eg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Resident of Anesthesiology, Surgical Intensive Care and Pain Medicine

Study Record Dates

• First Submitted: January 31, 2023
• First Posted: February 9, 2023
• Study Start: August 10, 2023
• Primary Completion: August 10, 2023
• Study Completion: August 10, 2023
• Last Updated: February 9, 2023

Record last verified: 2023-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: For one year after completion of the study

Locations

EG (1)