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

Primary Purpose

Alveolar Recruitment Maneuvers, Atelectasis, Bariatric Surgery

Status
Not yet recruiting
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Lachmann maneuver
Staircase maneuver
Sponsored by
Tanta University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Alveolar Recruitment Maneuvers

Eligibility Criteria

21 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Alaa Mohsen Shahien

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Lachmann maneuver

Staircase maneuver

Arm Description

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

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

Outcomes

Primary Outcome Measures

Improvement of Lung ultrasound score.
Access lung ultrasound score at the end of surgery

Secondary Outcome Measures

Access Pulmonary complications
Pulmonary complications were measured as (pneumonia, pulmonary edema, pleural effusion, and pneumothorax).
Access incidence of oxygen desaturation
incidence of oxygen desaturation was measured
Access Complications of recruitment maneuver
Complications of recruitment maneuver including bradycardia, hypotension were measured

Full Information

First Posted
January 31, 2023
Last Updated
January 31, 2023
Sponsor
Tanta University
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1. Study Identification

Unique Protocol Identification Number
NCT05720351
Brief Title
Alveolar Recruitment Maneuvers on Reduction of Lung Atelectasis in Bariatric Surgery by Using Lung Ultrasound Score
Official Title
Comparison Between Two Alveolar Recruitment Maneuvers on Reduction of Lung Atelectasis in Bariatric Surgery by Using Lung Ultrasound Score
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
August 10, 2023 (Anticipated)
Primary Completion Date
August 10, 2023 (Anticipated)
Study Completion Date
August 10, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Tanta University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. 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
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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alveolar Recruitment Maneuvers, Atelectasis, Bariatric Surgery

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Lachmann maneuver
Arm Type
Active Comparator
Arm Description
Patients undergone the Lachmann recruitment maneuver (30 CmH2O PEEP for 30 seconds)
Arm Title
Staircase maneuver
Arm Type
Active Comparator
Arm Description
Patients undergone staircase recruitment maneuver (stepped increase in PEEP by 2 CmH2O every five breaths until reach upper deflection point
Intervention Type
Procedure
Intervention Name(s)
Lachmann maneuver
Intervention Description
Patients undergone the Lachmann recruitment maneuver (30 CmH2O PEEP for 30 seconds)
Intervention Type
Procedure
Intervention Name(s)
Staircase maneuver
Intervention Description
Patients undergone Undergone staircase recruitment maneuver (stepped increase in PEEP by 2 CmH2O every five breaths until reach upper deflection point
Primary Outcome Measure Information:
Title
Improvement of Lung ultrasound score.
Description
Access lung ultrasound score at the end of surgery
Time Frame
48 hours postoperatively
Secondary Outcome Measure Information:
Title
Access Pulmonary complications
Description
Pulmonary complications were measured as (pneumonia, pulmonary edema, pleural effusion, and pneumothorax).
Time Frame
48 hours postoperatively
Title
Access incidence of oxygen desaturation
Description
incidence of oxygen desaturation was measured
Time Frame
48 hours Postoperatively
Title
Access Complications of recruitment maneuver
Description
Complications of recruitment maneuver including bradycardia, hypotension were measured
Time Frame
48 hours Postoperatively

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Alaa M Shahien, MD
Phone
+201555957744
Ext
+20
Email
alaa162094_pg@med.tanta.edu.eg
Facility Information:
Facility Name
Alaa Mohsen Shahien
City
Tanta
State/Province
ElGharbiaa
ZIP/Postal Code
31511
Country
Egypt
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Alaa M Shahien, MD
Phone
+20155 5957744
Ext
+20
Email
alaa162094_pg@med.tanta.edu.eg

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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

Learn more about this trial

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

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