The Effectiveness of Two Distinct Ventilation Strategies Escalating Positive End Expiratory Pressure (PEEP) and Lung Recruitment Maneuvers in Improving Oxygenation

NCT06847412 | Active Not Recruiting DMC

• 1 other identifier: FMASU MS 40/2025
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

This study evaluates and compares the effectiveness of two distinct ventilation strategies-escalating PEEP and lung recruitment maneuvers-in improving oxygenation (i.e., managing hypoxemia) in COPD patients undergoing VATS.

Conditions

Hypoxemia; COPD

Outcome Measures

Primary Outcomes (1)

• Incidence of ICU admission

  The incidence of post-operative patients requiring ICU admission

  6 months

Secondary Outcomes (1)

• Incidence of pulmonary complications

  6 months

Study Arms (2)

Group (A): Escalating PEEP

ACTIVE COMPARATOR

This group will undergo VATS \& one hypoxemia started PEEP is typically increased in 2-3 cm H₂O increments while monitoring the patient's response (oxygenation, hemodynamics, and lung compliance).

Device: Escalating PEEP

Group (B): Lung recruitment by Sustained inflation

ACTIVE COMPARATOR

A sustained inflation: Set the ventilator to CPAP mode and increase the pressure to 30 cm H2O for 30 s.

Device: Sustained inflation

Interventions

Escalating PEEP DEVICE

Typically, an initial PEEP of 5 cm H₂O, then PEEP is increased in 2-3 cm H₂O increments while monitoring the patient's response (oxygenation, hemodynamics, and lung compliance).

Group (A): Escalating PEEP

Sustained inflation DEVICE

Set the ventilator to CPAP mode and increase the pressure to 30 cm H2O for 30 s.

Group (B): Lung recruitment by Sustained inflation

Eligibility Criteria

• Age: 20 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Age ≥ 20 years and \</=60 years.
• Both sex.
• Patients American Society of Anesthesiologists Physical Status (ASA) Il to IIl.
• A written, valid, and informed consent
• Mild to moderate COPD patients
• BMI less than 4

You may not qualify if:

• Patient refusal.
• Pregnancy
• VATS procedure converted to open thoracotomy
• Patients have other lung diseases
• Patients ASA more than lll
• Patients with cardiac diseases affecting systolic \& diastolic functions

Sponsors & Collaborators

• Ain Shams University: lead

Study Sites (1)

Ain Shams university

Cairo, Egypt, 11111, Egypt

Location

MeSH Terms

Conditions

Hypoxia; Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes

Study Officials

• Ahmed Nagah AL Shaer, Professor

  Ain Shams University

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 21, 2025
• First Posted: February 26, 2025
• Study Start: January 30, 2025
• Primary Completion: July 27, 2025
• Study Completion: July 27, 2025
• Last Updated: March 11, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: Before 1/2026
• Access Criteria: Free

Locations

EG (1)