Effect of High Versus Low Fraction of Inspired Oxygen During Alveolar Recruitment

NCT06494410 | Completed DMC

• 1 other identifier: Abdallah Adel Saber
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

Intraoperative absorption atelectasis is associated with decreased lung compliance, impaired oxygenation, increased pulmonary vascular resistance, and lung injury. The alveolar recruitment maneuver (RM) with positive-end expiratory pressure (PEEP) has been advocated as efficient for absorption atelectasis treatment. During general anesthesia, absorption atelectasis reportedly occurs in most patients especially during laparoscopic surgery, the increased abdominal pressure of capnoperitoneum may shift the diaphragm cranially and decrease respiratory compliance

Conditions

Bariatric Surgery Candidate; Atelectasis

Outcome Measures

Primary Outcomes (1)

• Modified Lung Ultrasound Score (LUSS)

  1\. Modified LUSS at surgery completion compared to baseline preoperative modified LUSS, reflecting any aeration loss during general anesthesia.

  from 0 hours to 6 hours after the procedure

Study Arms (2)

High Fraction of Inspired Oxygen(Group A)

ACTIVE COMPARATOR

About 40 patients received FiO2 1.0 during recruitment maneuvers

Procedure: High versus Low Fraction of Inspired Oxygen

Low Fraction of Inspired Oxygen(Group B)

ACTIVE COMPARATOR

About 40 patients received FiO2 0.4 during recruitment maneuvers

Procedure: High versus Low Fraction of Inspired Oxygen

Interventions

High versus Low Fraction of Inspired Oxygen PROCEDURE

to compare the effect of high oxygen fraction (FiO2 1.0) vs. low oxygen fraction (FiO2 0.4) on clinical outcome on intraoperative and postoperative atelectasis and PPC. We will asses the impact of FiO2, especially during RM, on atelectasis development, using modified LUSS in obese patients with atelectasis undergoing laparoscopic bariatric surgery.

High Fraction of Inspired Oxygen(Group A); Low Fraction of Inspired Oxygen(Group B)

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Patients aged between 18 - 60 years old.
• Both genders.
• Preoperative Physical Status: ASA II, III Patients.
• BMI above 40 Kg/m2.
• Patients undergoing laparoscopic bariatric surgeries: laparoscopic mini gastric bypass, Roux-en-Y gastric bypass and revision bariatric surgery (redo bariatric surgery) with the presence of atelectasis confirmed radiologically by Chest X-ray (CXR) and CT Chest

You may not qualify if:

• Refusal of the intervention or participation in the study.
• Patient under age of 18 years old or above 60 years old.
• Preoperative Physical Status: ASA I, IV.
• Psychiatric illness.
• Known cases of chronic pulmonary disease e.g. COPD and bronchial asthma.
• Known cases of cardiac diseases.
• Previous lung surgery.
• Lactation.

Sponsors & Collaborators

• Egymedicalpedia: lead
• Ain Shams University: collaborator

Study Sites (1)

Ain Shams University Hospitals

Cairo, Abbasia, Egypt

Location

MeSH Terms

Conditions

Pulmonary Atelectasis

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases

Study Officials

• Madiha Metwaly Zidan, Professor

  Department of Anesthesia and I.C.U. faculty of Medicine,Ain Shams university, Egypt

  STUDY CHAIR

• Ahmed Ali Fawaz, Professor

  Department of Anesthesia and I.C.U. faculty of Medicine,Ain Shams university, Egypt

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 2, 2024
• First Posted: July 10, 2024
• Study Start: February 7, 2023
• Primary Completion: July 7, 2024
• Study Completion: July 10, 2024
• Last Updated: July 15, 2024

Record last verified: 2023-02

Locations

EG (1)