MedTrace Logo

Pressure Release Ventilation Compared to Lung Protective Ventilation in Moderate and Severe ARDS

NCT07803614 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2026-09-03

No results posted yet for this study

Summary

This study compares two different ways of providing mechanical ventilation to patients with moderate to severe acute respiratory distress syndrome (ARDS), a serious condition in which the lungs become inflamed and make it difficult to breathe and maintain normal oxygen levels. Patients are randomly assigned to receive either airway pressure release ventilation (APRV) or conventional low-tidal-volume ventilation (LTV). The study compares the two ventilation strategies in terms of successful removal from the ventilator, time needed on mechanical ventilation, improvement in blood oxygen levels, length of stay in the intensive care unit and hospital, and complications such as the need for reintubation, barotrauma, and death. The aim is to determine whether APRV provides better outcomes than conventional low-tidal-volume ventilation in patients with moderate to severe ARDS.

Conditions

  • ARDS (Acute Respiratory Distress Syndrome)

Interventions

BEHAVIORAL

Arm 1 Intervention Name: Low-Tidal-Volume Ventilation (LTV)

For LTV Participants received conventional low-tidal-volume mechanical ventilation using a tidal volume of 4-8 mL/kg predicted body weight, with plateau pressure maintained below 30 cmH₂O. Ventilator settings were adjusted according to oxygenation, ventilation, respiratory mechanics, and hemodynamic status. FiO₂ and PEEP were adjusted to maintain the predefined oxygenation target. Patients underwent the standardized weaning and spontaneous breathing trial protocol used in both study groups. For APRV Participants received airway pressure release ventilation using two airway pressure levels (P-high and P-low), prolonged T-high, and brief T-low periods. P-high was initially set at 20-30 cmH₂O and P-low at 5 cmH₂O. T-high was initially set at 4-6 seconds and T-low at 0.6 seconds, with T-low subsequently adjusted according to the expiratory-flow waveform to limit excessive expiratory lung emptying and maintain end-expiratory lung volume. FiO₂ was adjusted to maintain SpO₂ at 88-95%. Rele

Sponsors & Collaborators

  • Koot Ahmad

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-04-30
Primary Completion
2026-08-20
Completion
2026-08-21

Countries

  • Egypt

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07803614 on ClinicalTrials.gov