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Clinical Trials/NCT05406427
NCT05406427
Unknown
Not Applicable

Monitorings the Physiological Mechanism of Airway Pressure Release Ventilation(APRV) in Acute Respiratory Distress Syndrome (ARDS) Patients by Electrical Impedance Tomography(EIT)

Wuhan Union Hospital, China1 site in 1 country30 target enrollmentMarch 1, 2022

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Electrical Impedance Tomography
Sponsor
Wuhan Union Hospital, China
Enrollment
30
Locations
1
Primary Endpoint
tidal volume distribution during APRV at 24 hours after APRV
Last Updated
3 years ago

Overview

Brief Summary

Effects of airway pressure release ventilation on pulmonary ventilation, shunt and perfusion in patients with ARDS

Detailed Description

Effects of airway pressure release ventilation on respiratory mechanisms including ventilation distribution, intrapulmonary shunt and V/Q match in lungs of ARDS evaluated by EIT at different time points.

Registry
clinicaltrials.gov
Start Date
March 1, 2022
End Date
March 1, 2024
Last Updated
3 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
Wuhan Union Hospital, China
Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • 18 years old \< age \< 80 years old
  • Diagnosed as moderate or severe ARDS according to the Berlin 2014 definition
  • Predicted APRV mechanical ventilation for more than 72 hours

Exclusion Criteria

  • Excluded if any of the following exclusion criteria are met:
  • APRV contraindications such as pneumothorax, severe chronic obstructive pulmonary disease, severe asthma, intracranial hypertension
  • Pregnant women
  • Severe cardiac dysfunction (New York Heart Association class III or IV, acute coronary syndrome or sustained ventricular tachyarrhythmia), right heart enlargement due to chronic cardiopulmonary disease, cardiogenic shock or cardiac hand
  • Refractory shock

Outcomes

Primary Outcomes

tidal volume distribution during APRV at 24 hours after APRV

Time Frame: 24 hours after APRV mechanical ventilation

we will use electrical impedance tomography(EIT) to monitor tidal volume distribution during APRV

Secondary Outcomes

  • tidal volume distribution during APRV(Before APRV mechanical ventilation and 2, 6, 12, 48, 72 hours after APRV mechanical ventilation)
  • Right ventricular area fractional change(Before APRV mechanical ventilation and 2, 6, 12, 24, 48, 72 hours after APRV mechanical ventilation)
  • Tricuspid annular systolic S' velocity (TS')(Before APRV mechanical ventilation and 2, 6, 12, 24, 48, 72 hours after APRV mechanical ventilation)
  • V/Q match(Before APRV mechanical ventilation and 2, 6, 12, 24, 48, 72 hours after APRV mechanical ventilation)
  • Positive end breath pressure(Before APRV mechanical ventilation and 2, 6, 12, 24, 48, 72 hours after APRV mechanical ventilation)
  • Tricuspid annular systolic displacement (TAPSE)(Before APRV mechanical ventilation and 2, 6, 12, 24, 48, 72 hours after APRV mechanical ventilation)
  • Right ventricular end-diastolic area/left ventricular end-diastolic area (RVEDA/LVEDA)(Before APRV mechanical ventilation and 2, 6, 12, 24, 48, 72 hours after APRV mechanical ventilation)
  • Mean arterial pressure (MAP)(Before APRV mechanical ventilation and 2, 6, 12, 24, 48, 72 hours after APRV mechanical ventilation)
  • Intrapulmonary shunt during APRV(Before APRV mechanical ventilation and 2, 6, 12, 24, 48, 72 hours after APRV mechanical ventilation)
  • Driving pressure(DP)(Before APRV mechanical ventilation and 2, 6, 12, 24, 48, 72 hours after APRV mechanical ventilation)
  • stroke volume index(SVI)(Before APRV mechanical ventilation and 2, 6, 12, 24, 48, 72 hours after APRV mechanical ventilation)
  • Mortality at 28 days after randomization(28 days after the beginning of randomization)
  • Plateau pressure(Before APRV mechanical ventilation and 2, 6, 12, 24, 48, 72 hours after APRV mechanical ventilation)
  • Compliances(Cs)(Before APRV mechanical ventilation and 2, 6, 12, 24, 48, 72 hours after APRV mechanical ventilation)
  • Peak pressure(Before APRV mechanical ventilation and 2, 6, 12, 24, 48, 72 hours after APRV mechanical ventilation)
  • Pulmonary circulatory resistance (PVR)(Before APRV mechanical ventilation and 2, 6, 12, 24, 48, 72 hours after APRV mechanical ventilation)
  • cardiac index (CI)(Before APRV mechanical ventilation and 2, 6, 12, 24, 48, 72 hours after APRV mechanical ventilation)
  • Heart rate(HR)(Before APRV mechanical ventilation and 2, 6, 12, 24, 48, 72 hours after APRV mechanical ventilation)
  • Mean pressure(Before APRV mechanical ventilation and 2, 6, 12, 24, 48, 72 hours after APRV mechanical ventilation)
  • tidal volume(Vt)(Before APRV mechanical ventilation and 2, 6, 12, 24, 48, 72 hours after APRV mechanical ventilation)
  • Systolic blood pressure(SBP)(Before APRV mechanical ventilation and 2, 6, 12, 24, 48, 72 hours after APRV mechanical ventilation)
  • Cardiac output(CO)(Before APRV mechanical ventilation and 2, 6, 12, 24, 48, 72 hours after APRV mechanical ventilation)
  • Stroke volume(Before APRV mechanical ventilation and 2, 6, 12, 24, 48, 72 hours after APRV mechanical ventilation)
  • oxygenation index(Before APRV mechanical ventilation and 2, 6, 12, 24, 48, 72 hours after APRV mechanical ventilation)
  • ICU length of stay(the whole period of stay in ICU from the day of randomization to the day of discharge from ICU or the day of death,assessed up to 90 days)
  • Arterial partial pressure of carbon dioxide(PaCO2)(Before APRV mechanical ventilation and 2, 6, 12, 24, 48, 72 hours after APRV mechanical ventilation)
  • Sequential Organ Failure Assessment score(2 hours within admission to ICU and 24 hours after inclusion in the study)
  • Arterial partial pressure of oxygen (PaO2)(Before APRV mechanical ventilation and 2, 6, 12, 24, 48, 72 hours after APRV mechanical ventilation)
  • Acute Physiology and Chronic Health Evaluation score(2 hours within admission to ICU and 24 hours after inclusion in the study)
  • Duration of ventilation after randomization(from the day of randomization to the day of extubation or the day of death,assessed up to 90 days)

Study Sites (1)

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