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

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

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

Study Overview

• Status: Not yet recruiting
• Conditions: Bariatric Surgery; Atelectasis; Alveolar Recruitment Maneuvers
• Intervention / Treatment: Procedure: Lachmann maneuver; Procedure: Staircase maneuver

Detailed Description

Weight loss surgery, often known as bariatric surgery, is an effective obesity treatment. Most people undergoing such surgery may show an improvement in, or the resolution of, conditions such as diabetes, dyslipidemia, hypertension, and obstructive sleep apnea.

Currently, there is no standard ventilation strategy has been established for obese patients. However, there is some evidence that recruitment maneuvers (RM) combined with protective lung ventilation strategy improve oxygenation and compliance compared to other strategies.

Alveolar recruitment maneuver refers to the periodic hyperinflation of the lungs that has been utilized to open up the lung and keep the lung open in anesthetized patients. The use of recruitment maneuvers has been shown to reduce the incidence and extent of atelectasis during general anesthesia by different methods.

Lung ultrasonography is considered a useful tool in perioperative care. Recent research showed that lung ultrasound could assess lung aeration and diagnose anesthesia-induced atelectasis accurately in the perioperative period by measuring the extent of atelectasis by the scoring system; also, the response to recruitment manoeuver for each patient can be evaluated easily. Thus, it has great potential as a bedside non-invasive, sensitive tool for guiding effective recruitment manoeuvers to reduce the formation of pulmonary atelectasis in the surgical setting

• Study Type: Interventional
• Enrollment (Anticipated): 50
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Alaa M Shahien, MD; Phone Number: +20 +201555957744; Email: alaa162094_pg@med.tanta.edu.eg

Study Locations

• Egypt
  • ElGharbiaa
    • Tanta, ElGharbiaa, Egypt, 31511
      • Alaa Mohsen Shahien
      • Contact: Alaa M Shahien, MD; Phone Number: +20 +20155 5957744; Email: alaa162094_pg@med.tanta.edu.eg

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years to 65 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: DIAGNOSTIC
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: Lachmann maneuver; Patients undergone the Lachmann recruitment maneuver (30 CmH2O PEEP for 30 seconds)	Procedure: Lachmann maneuver; Patients undergone the Lachmann recruitment maneuver (30 CmH2O PEEP for 30 seconds)
ACTIVE_COMPARATOR: Staircase maneuver; Patients undergone staircase recruitment maneuver (stepped increase in PEEP by 2 CmH2O every five breaths until reach upper deflection point	Procedure: Staircase maneuver; Patients undergone Undergone staircase recruitment maneuver (stepped increase in PEEP by 2 CmH2O every five breaths until reach upper deflection point

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Improvement of Lung ultrasound score.	Access lung ultrasound score at the end of surgery	48 hours postoperatively

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Access Pulmonary complications	Pulmonary complications were measured as (pneumonia, pulmonary edema, pleural effusion, and pneumothorax).	48 hours postoperatively
Access incidence of oxygen desaturation	incidence of oxygen desaturation was measured	48 hours Postoperatively
Access Complications of recruitment maneuver	Complications of recruitment maneuver including bradycardia, hypotension were measured	48 hours Postoperatively

Collaborators and Investigators

• Sponsor: Tanta University

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): August 10, 2023
• Primary Completion (ANTICIPATED): August 10, 2023
• Study Completion (ANTICIPATED): August 10, 2023

Study Registration Dates

• First Submitted: January 31, 2023
• First Submitted That Met QC Criteria: January 31, 2023
• First Posted (ESTIMATE): February 9, 2023

Study Record Updates

• Last Update Posted (ESTIMATE): February 9, 2023
• Last Update Submitted That Met QC Criteria: January 31, 2023
• Last Verified: January 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Lung Diseases; Pulmonary Atelectasis
• Other Study ID Numbers: 35292\2\22

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: The data will be available upon reasonable request from the principal investigator
• IPD Sharing Time Frame: For one year after completion of the study
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP

Drug and device information, study documents

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