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

NCT07803614 | Completed DMC

• 1 other identifier: ms 24-5-2025
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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)

Keywords

Acute respiratory distress syndrome; Airway pressure release ventilation (APRV); Low-tidal-volume ventilation (LTV); Acute respiratory failure; Extubation; Oxygenation

Outcome Measures

Primary Outcomes (1)

• Successful extubation

  Liberation from invasive mechanical ventilation without the need for reintubation within 72 hours after extubation.

  From randomization until 72 hours after extubation

Secondary Outcomes (4)

• Time to successful extubation

  From randomization until successful extubation, hospital discharge, or death, whichever occurred first; assessed up to 30 days.

• Change in PaO₂/FiO₂ ratio

  At baseline and 1, 3, and 7 days after initiation of the assigned ventilatory strategy.

• ICU length of stay

  From ICU admission until ICU discharge or death, whichever occurred first, assessed up to 30 days.

• Hospital length of stay

  From hospital admission until hospital discharge or death, whichever occurred first, assessed up to 30 days.

Study Arms (2)

Low-Tidal-Volume Ventilation (LTV)

ACTIVE COMPARATOR

Participants assigned to the LTV group received conventional lung-protective mechanical ventilation using a tidal volume of 4-8 mL/kg predicted body weight, with adjustment according to respiratory mechanics and clinical response. Plateau pressure was maintained below 30 cmH₂O. Ventilator settings were adjusted according to oxygenation, ventilation, respiratory mechanics, and hemodynamic status.

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

Airway Pressure Release Ventilation (APRV)

EXPERIMENTAL

Participants assigned to the APRV group received airway pressure release ventilation using two airway pressure levels, prolonged T-high, and brief T-low periods. P-high was initially set at 20-30 cmH₂O and subsequently adjusted according to oxygenation and respiratory mechanics. P-low was set at 5 cmH₂O. T-high was initially set at 4-6 seconds, while T-low was initially set at 0.6 seconds and 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%. Release tidal volume, minute ventilation, and static respiratory-system compliance were monitored.

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

Interventions

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

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

Airway Pressure Release Ventilation (APRV); Low-Tidal-Volume Ventilation (LTV)

Eligibility Criteria

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

You may qualify if:

• Adult patients aged 18 years or older.
• Mechanically ventilated patients admitted to the Intensive Care Unit (ICU) at Banha University Hospital.
• Patients diagnosed with moderate-to-severe acute respiratory distress syndrome (ARDS) according to the 2023 European Society of Intensive Care Medicine (ESICM) guidelines, characterized by (Matthay et al., 2024):
• An acute predisposing risk factor (e.g., pneumonia, non-pulmonary infection, trauma, transfusion, aspiration, or shock), with pulmonary edema not primarily attributable to cardiogenic causes or fluid overload.
• Acute onset or worsening of hypoxemic respiratory failure within one week of the onset of the predisposing risk factor or new/worsening respiratory symptoms.
• Bilateral pulmonary opacities on chest radiography, computed tomography, or lung ultrasound that are not fully explained by pleural effusions, atelectasis, or pulmonary nodules/masses.
• Moderate ARDS defined as a PaO₂/FiO₂ ratio \>100 to ≤200 mmHg (or SpO₂/FiO₂ ratio \>148 to ≤235 when SpO₂ \<97%) or severe ARDS defined as a PaO₂/FiO₂ ratio ≤100 mmHg (or SpO₂/FiO₂ ratio ≤148).

You may not qualify if:

• Patients younger than 18 years of age.
• Pregnant women.
• Patients with severe chronic heart failure (New York Heart Association Class III or IV).
• Patients with uncontrolled shock requiring escalating doses of vasopressor support.
• Patients with severe cardiac arrhythmias or active myocardial ischemia.

Sponsors & Collaborators

• Koot Ahmad: lead

Study Sites (1)

Benha University Hospital

Banhā, Qalyubia Governorate, 6460001, Egypt

Location

MeSH Terms

Conditions

Acute Lung Injury; Respiratory Distress Syndrome

Condition Hierarchy (Ancestors)

Lung Injury; Lung Diseases; Respiratory Tract Diseases; Respiration Disorders

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Outcome assessors were not involved in patient care or allocation and were blinded to the assigned ventilation strategy when assessing study outcomes.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: lecturer

Model Details: Participants were randomly assigned in a 1:1 ratio to one of two parallel ventilation strategies: airway pressure release ventilation (APRV) or conventional low-tidal-volume ventilation (LTV). Participants remained in their assigned group throughout the study, and outcomes were compared between the two groups.

Study Record Dates

• First Submitted: August 24, 2026
• First Posted: September 3, 2026
• Study Start: April 30, 2025
• Primary Completion: August 20, 2026
• Study Completion: August 21, 2026
• Last Updated: September 3, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: IPD and supporting information will be available beginning after publication of the study results and will remain available indefinitely, subject to approval of data-sharing requests and applicable ethical and confidentiality requirements.
• Access Criteria: Qualified researchers may request access to de-identified individual participant data and selected supporting documents for scientifically valid research purposes. Requests will be reviewed by the study investigators for consistency with informed consent, ethical requirements, and data-protection regulations. Approved data will be shared securely following appropriate confidentiality and data-use agreements.

Locations

EG (1)