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Effect of Spontaneous Breathing in APRV Mode on Respiratory Physiology of ARDS Patients

NCT07798154 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 15

Last updated 2026-09-01

No results posted yet for this study

Summary

This is a single-center, prospective, randomized, three-period crossover physiological study in adult patients with moderate-to-severe acute respiratory distress syndrome (ARDS, PaO₂/FiO₂ ≤150 mmHg). Each enrolled subject will receive all three APRV ventilation conditions in random sequence: low-level spontaneous breathing (spontaneous minute-ventilation proportion 10%-30%), high-level spontaneous breathing (31%-50%), and fully suppressed spontaneous breathing as control. A 30-minute wash-out period is set between each condition to restore unified physiological baseline. Primary outcome is ventilation-perfusion mismatch percentage (mismatch%) measured by Electrical Impedance Tomography (EIT). Secondary outcomes include EIT-derived pulmonary parameters, respiratory mechanics, hemodynamics, diaphragmatic function and safety profiles. Only short-term, reversible ventilator and sedation adjustments will be performed; routine clinical management remains unchanged throughout the trial.

Conditions

  • Acute Respiratory Distress Syndrome

Interventions

DEVICE

APRV ventilation with low-level spontaneous breathing

APRV ventilation mode, spontaneous-contributed minute-ventilation proportion maintained at 10%-30%. 30-minute stabilization before outcome measurement.

DEVICE

APRV ventilation with high-level spontaneous breathing

APRV ventilation mode, spontaneous-contributed minute-ventilation proportion maintained at 31%-50%. 30-minute stabilization before outcome measurement.

DEVICE

APRV ventilation with fully suppressed spontaneous breathing

APRV ventilation mode, spontaneous breathing fully suppressed by deep sedation (RASS-4 to -5). 30-minute stabilization before outcome measurement.

Sponsors & Collaborators

  • Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

    lead OTHER

Principal Investigators

  • xiaojing zou, MD · Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-10-01
Primary Completion
2026-11-30
Completion
2026-12-31

Countries

  • China

Study Locations

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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 NCT07798154 on ClinicalTrials.gov