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

• Sponsor: Tanta University (Other)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT05720351
• Collaborator: (none)
• Enrollment: 50
• Location: 1
• Arms: 2

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Alveolar Recruitment Maneuvers; Atelectasis; Bariatric Surgery	Procedure: Lachmann maneuver; Procedure: Staircase maneuver	N/A

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 Design

• Study Type: Interventional
• Anticipated Enrollment: 50 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Diagnostic
• Official Title: Comparison Between Two Alveolar Recruitment Maneuvers on Reduction of Lung Atelectasis in Bariatric Surgery by Using Lung Ultrasound Score
• Anticipated Study Start Date: Aug 10, 2023
• Anticipated Primary Completion Date: Aug 10, 2023
• Anticipated Study Completion Date: Aug 10, 2023

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Improvement of Lung ultrasound score. [48 hours postoperatively]

   Access lung ultrasound score at the end of surgery

Secondary Outcome Measures

1. Access Pulmonary complications [48 hours postoperatively]

   Pulmonary complications were measured as (pneumonia, pulmonary edema, pleural effusion, and pneumothorax).

2. Access incidence of oxygen desaturation [48 hours Postoperatively]

   incidence of oxygen desaturation was measured

3. Access Complications of recruitment maneuver [48 hours Postoperatively]

   Complications of recruitment maneuver including bradycardia, hypotension were measured

Eligibility Criteria

Criteria

• Ages Eligible for Study: 21 Years to 65 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Alaa Mohsen Shahien	Tanta	ElGharbiaa	Egypt	31511

Sponsors and Collaborators

• Tanta University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Alaa Mohsen Shahien, Resident of Anesthesiology, Surgical Intensive Care and Pain Medicine, Tanta University
• ClinicalTrials.gov Identifier: NCT05720351
• Other Study ID Numbers: 35292\2\22
• First Posted: Feb 9, 2023
• Last Update Posted: Feb 9, 2023
• Last Verified: Jan 1, 2023

• Individual Participant Data (IPD) Sharing Statement: Yes
• Plan to Share IPD: Yes
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Pulmonary Atelectasis

Study Results

No Results Posted as of Feb 9, 2023