Lung Recruitment Manoeuvre in Morbidly Obese Patients Underdoing Laparoscopic Bariatric Surgery

NCT06000969 | Completed

• 1 other identifier: 36264MD12
• Study Type: interventional
• Target: 78
• Locations: 1 country
• Sites: 2

Brief Summary

Lung ultrasonography is an easy-to-use, portable, non-invasive, visual, and non-radiative technique that has been widely used in clinical monitoring and diagnosis. Many studies have demonstrated that pulmonary ultrasonography can evaluate the degree of aeration loss and diagnose atelectasis accurately by using a validated semiquantitative score in the perioperative period, and lung ultrasonic imaging can be conducive to confirming the effects of lung recruitment manoeuvres. This clinical trial suggested that the use of ultrasound-guided recruitment maneuver in morbidly obese patients scheduled for laparoscopic bariatric surgery can improve the lung aeration, decrease the incidence of basal lung atelectasis, decrease the incidence of intraoperative\& postoperative oxygen desaturation, and reduce the incidence of post operative pulmonary complications. The aim of this prospective randomized clinical study is to compare the conventional recruitment manoeuvre and ultrasound-guided recruitment manoeuvre in morbidly obese patients scheduled for laparoscopic bariatric surgery.

Conditions

Bariatric Surgery; Obesity, Morbid

Keywords

Morbidly obese, Bariatric surgery, Lung recruitment

Outcome Measures

Primary Outcomes (1)

• the change of Lung Ultrasound Score

  Assessment of the changes in the lung ultrasound score

  2 hours

Secondary Outcomes (2)

• The incidence of atelectasis

  2 hours

• The incidence of intra-operative desaturation

  3 hours

Study Arms (2)

Conventional group (group C)

EXPERIMENTAL

Patients will be shifted to 100% Oxygen then; the recruitment maneuver will be performed by manual inflation with a pressure of 30 cmH2O for 30 seconds.

Device: Lung Recruitment Conventional

Ultrasound-guided group (group US)

EXPERIMENTAL

Patients will be shifted to 100% Oxygen then; the recruitment maneuver will be performed under the direct real-time guidance of ultrasound if atelectasis (defined as LUS of ≥ 2 for any of the 12 regions) is present. This will be done by manual inflation with a pressure of 10 cmH2O for 10 seconds, increased 10 cmH2O every 10 seconds until no collapsed areas are visible on the ultrasound, the maximum airway pressure will be limited to 40 cmH2O. This could be repeated if needed.

Device: Lung Recruitment Ultrasound

Interventions

Lung Recruitment Conventional DEVICE

the recruitment maneuver will be performed by manual inflation with a pressure of 30 cmH2O for 30 seconds.

Conventional group (group C)

Lung Recruitment Ultrasound DEVICE

the recruitment maneuver will be performed under the direct real-time guidance of ultrasound if atelectasis (defined as LUS of ≥ 2 for any of the 12 regions) is present. This will be done by manual inflation with a pressure of 10 cmH2O for 10 seconds, increased 10 cmH2O every 10 seconds until no collapsed areas are visible on the ultrasound, the maximum airway pressure will be limited to 40 cmH2O. This could be repeated if needed.

Ultrasound-guided group (group US)

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 of BMI more than 40, scheduled for laparoscopic bariatric surgery

You may not qualify if:

• Patient refusal
• Patients with history of severe obstructive or restrictive pulmonary disease.
• Patients with severe obstructive sleep apnea (OSA).
• Presence of emphysematous lung bullae.
• Decompensated cardiac disease (NYHA class 3 or 4).
• Patients with uncontrolled hepatic or renal disorders.

Sponsors & Collaborators

• Tanta University: lead

Study Sites (2)

Tanta University

Tanta, Algharbia, 31511, Egypt

Location

Tanta University hospitals

Tanta, 31511, Egypt

Location

MeSH Terms

Conditions

Obesity, Morbid

Condition Hierarchy (Ancestors)

Obesity; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Sameh Ismaiel, M.D

  Assistant Professor of Anesthesia and Intensive Care, Tanta University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: * The participants will be kept blind through the use of ultrasound assessment in both groups. * Outcome assessors will be blinded as they will be anesthesia resident and nurse not participating in the study.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Anesthesia and Intensive Care

Model Details: Patients will be randomly allocated in one of the two equal groups using a computer-generated table of random numbers to :- * Conventional group (group C); 30 patients: * Ultrasound-guided group (group US); 30 patients:

Study Record Dates

• First Submitted: August 11, 2023
• First Posted: August 21, 2023
• Study Start: August 14, 2023
• Primary Completion: November 1, 2024
• Study Completion: November 1, 2024
• Last Updated: December 3, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: within 6 months after publishing the study.
• Access Criteria: Contact samehabdelkhalik1982@gmail.com

Locations

EG (2)