Effects of Alveolar Recruitment Strategies on Arterial Oxygenation and Postoperative Inflammatory Response During Laparoscopic Bariatric Surgery: A Randomised Control Trial.

NCT05960071 | Completed DMC

• 1 other identifier: 0305904
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

even though the advancement of ambulatory bariatric surgeries, yet the precise spot of recruitment manoeuvres as a secure and efficient approach to enhance the respiratory efficacy of obese patients is still obscured. Previous research have extensively focused their attention towards alveolar recruitment with various positive end-expiratory pressure (PEEP) levels to alleviate anaesthesia induced pulmonary collapse and enhance arterial oxygenation. Patients and methods: a prospective randomized study involved 60 adult obese patients (18-65 years), with American Society of Anaesthesiologists physical Status classification 1-2, enrolled in 2 groups; Group S: received protective lung strategy with recruitment manoeuvre (RM) every 30 minutes and steady PEEP (10) cm H2o in between RM till end of surgery. Group D: received protective lung strategy with recruitment manoeuvre (RM) every 30 minutes and decreasing PEEP (15, 10, and 5) cm H20 (10 minutes for each level) in between RM till end of surgery.

Conditions

Bariatric Surgery Candidate

Keywords

bariatric; atelectasis; alveolar recruitment

Outcome Measures

Primary Outcomes (2)

• Partial arterial tension of oxygen (PaO2),

  20 minutes postoperatively

• Serum interleukins (IL)-6

  after 24 hours postoperative

Study Arms (2)

Group S

ACTIVE COMPARATOR

patients received protective lung strategy with recruitment manoeuvre (RM) every 30 minutes and steady PEEP (10) cm H2O in between RM till end of surgery.

Procedure: protective lung strategy with recruitment manoeuvre (RM) - steady PEEP

Group D

ACTIVE COMPARATOR

patients received protective lung strategy with recruitment manoeuvre (RM) every 30 minutes and decreasing PEEP (15, 10, and 5) cm H20 (10 minutes for each level) in between RM till end of surgery.

Procedure: protective lung strategy with recruitment manoeuvre (RM) - decreasing PEEP

Interventions

protective lung strategy with recruitment manoeuvre (RM) - steady PEEP PROCEDURE

protective lung strategy with recruitment manoeuvre (RM) every 30 minutes and steady PEEP (10) cm H2o in between RM till end of surgery.

Group S

protective lung strategy with recruitment manoeuvre (RM) - decreasing PEEP PROCEDURE

protective lung strategy with recruitment manoeuvre (RM) every 30 minutes and decreasing PEEP (15, 10, and 5) cm H20 (10 minutes for each level) in between RM till end of surgery.

Group D

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \- American Society of Anaesthesiologists physical Status classification scores of 1-2, scheduled for laparoscopic bariatric procedures

You may not qualify if:

• patients refusal,
• history of significant pulmonary disease (obstructive or restrictive),
• previous pneumothorax,
• significant cardiac dysfunction (arrhythmias ± unstable haemodynamics
• left ventricular ejection fraction \< 40%)
• difficult intubation
• significant hepatic or renal impairment.

Sponsors & Collaborators

• Alexandria University: lead

Study Sites (1)

Alexandria University Faculty of Medicin

Alexandria, 21615, Egypt

Location

MeSH Terms

Conditions

Pulmonary Atelectasis

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: single blinded study where participants were not aware to the study design.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 60 adult obese patients (18-65 years), with American Society of Anaesthesiologists physical Status classification 1-2, enrolled in 2 groups; Group S: received protective lung strategy with recruitment manoeuvre (RM) every 30 minutes and steady PEEP (10) cm H2o in between RM till end of surgery. Group D: received protective lung strategy with recruitment manoeuvre (RM) every 30 minutes and decreasing PEEP (15, 10, and 5) cm H20 (10 minutes for each level) in between RM till end of surgery.

Study Record Dates

• First Submitted: July 18, 2023
• First Posted: July 25, 2023
• Study Start: November 5, 2022
• Primary Completion: April 30, 2023
• Study Completion: June 5, 2023
• Last Updated: July 25, 2023

Record last verified: 2023-06

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)