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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-80
SponsorUnion Hospital, Tongji Medical College, Huazhong University of Science and Technology

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

1. Age ≥18 and ≤80 years old. 2. Diagnosed with moderate-to-severe ARDS according to the 2023 global ARDS definition.

Disqualifiers

1. Refractory shock defined as persistent hyperlactatemia and/or prolonged capillary refill time, fluid-resistant, requiring norepinephrine ≥ 0.5 μg/kg/min.

Trial design

Design model

Crossover

Treatments tested in this trial

  • APRV ventilation with low-level spontaneous breathing

    Device

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

  • APRV ventilation with high-level spontaneous breathing

    Device

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

  • APRV ventilation with fully suppressed spontaneous breathing

    Device

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

Treatment groups

15 Participants
are divided into 3 treatment groups
Group A: Low-level spontaneous breathing under APRVExperimental treatment 1 intervention
Group B: High-level spontaneous breathing under APRVExperimental treatment 1 intervention
Group C: Fully suppressed spontaneous breathing under APRVExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Ventilation-perfusion mismatch percentage (Mismatch%)

Ventilation-perfusion mismatch percentage (Mismatch%), calculated as the sum of dead-space percentage and shunt percentage measured by electrical impedance tomography (EIT). A composite index reflecting overall ventilation-perfusion mismatch, assessed at baseline and under three APRV experimental conditions. Unit: %

Time frame
Baseline and at the end of each 30-minute experimental condition during the study intervention period.

Secondary outcomes

1

Match percentage(match%)

Match percentage derived from electrical impedance tomography (EIT). Unit: %.

Time frame
Baseline and at the end of each 30-minute experimental condition during the study intervention period.
2

Pendelluft amplitude

Pendelluft amplitude derived from electrical impedance tomography (EIT). Unit: %.

Time frame
Baseline and at the end of each 30-minute experimental condition during the study intervention period.
3

Dead-space percentage

Dead-space percentage derived from electrical impedance tomography (EIT), assessed at baseline and under three APRV experimental conditions. Unit: %.

Time frame
Baseline and at the end of each 30-minute experimental condition during the study intervention period.
4

Shunt percentage

Intrapulmonary shunt percentage derived from electrical impedance tomography (EIT), assessed at baseline and under three APRV experimental conditions. Unit: %.

Time frame
Baseline and at the end of each 30-minute experimental condition during the study intervention period.

Other outcomes

1

Incidence and severity of adverse events

Incidence and severity of adverse events during study interventions, focusing on respiratory events, circulatory events and procedure-related adverse events. Unit: unitless.

Time frame
During each APRV experimental intervention period
2

Rate of premature intervention discontinuation for safety concerns

Rate of premature discontinuation of study interventions due to safety-related reasons. Unit: %.

Time frame
During each APRV experimental intervention period
3

Inspired oxygen fraction (FiO₂)

Set inspired oxygen fraction, obtained directly from ventilator readings, recorded at baseline (prior to intervention, after stabilization) and at the end of each 30-minute APRV experimental condition (after stabilization). Unit: %.

Time frame
Baseline and at the end of each 30-minute experimental condition during the study intervention period.
4

Arterial pH

Arterial blood pH measured from arterial blood gas analysis, measured at baseline (prior to intervention, after stabilization) and at the end of each 30-minute APRV experimental condition (after stabilization). Unit: unitless.

Time frame
Baseline and at the end of each 30-minute experimental condition during the study intervention period.

Sponsors and contacts

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