Clinical trial NCT05414110: Effect of Airway Pressure Release Ventilation on Right Ventricular Function Assessed by Transthoracic Echocardiography
Official title: Effect of Airway Pressure Release Ventilation(APRV) on Right Ventricular Function Assessed by Transthoracic Echocardiography
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Ventilation Therapy; Complications
Right Ventricular Function
ARDS
Transthoracic Echocardiography
Lead sponsor: Wuhan Union Hospital, China
Sponsor class: OTHER
First posted: 2022-06-10
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Include as many eligible study populations as possible by study protocol

Brief summary: Effects of APRV on right ventricular function in patients with acute respiratory distress syndrome by transthoracic echocardiography

Detailed description: Effects of APRV on right ventricular function in patients with acute respiratory distress syndrome(ARDS) by transthoracic echocardiography，which includes TAPSE, S' by TDI, RV FAC, tricuspid regurgitation,RVEDA/LVEDA,RV, Velocity time integration(VTI) of the left ventricular outflow tract blood flow.

Eligibility criteria: Inclusion Criteria:

1. Patients who meet the 2012 Berlin ARDS diagnostic criteria and undergo invasive mechanical ventilation
2. PEEP≥5cmH2O, oxygenation index≤200mmHg
3. Endotracheal intubation and mechanical ventilation time \<48h
4. Age ≥18 years old and ≤80 years old

Exclusion Criteria:

1. Aged less than 18 years old or older than 80 years old
2. Obese patients with BMI≥35kg/m2;
3. Pregnant and lactating women
4. The expected time of invasive mechanical ventilation is expected to be less than 48h
5. Neuromuscular disease known to require prolonged mechanical ventilation
6. Severe chronic obstructive pulmonary disease
7. Intracranial hypertension
8. Bullae or pneumothorax, subcutaneous emphysema, mediastinal emphysema
9. extracorporeal membrane oxygenation(ECMO) has been performed when entering the ICU
10. Refractory shock
11. Severe cardiac dysfunction (New York Heart Association class III or IV, acute coronary syndrome or persistent ventricular tachyarrhythmia), right heart enlargement due to chronic cardiopulmonary disease, cardiogenic shock or heart enlargement postoperative;
12. Failure to sign informed consent

Primary outcomes:
measure: Right ventricular area fractional change (RV FAC)
timeFrame: RV FAC monitoring was performed 1 day after APRV mechanical ventilation
measure: Tricuspid annular systolic displacement(TAPSE)
timeFrame: TAPSE monitoring was performed 1 day after APRV mechanical ventilation
measure: Tricuspid annular systolic S' velocity (TS')
timeFrame: TS' monitoring was performed 1 day after APRV mechanical ventilation
measure: Right ventricular end-diastolic area/left ventricular end-diastolic area (RVEDA/LVEDA)
timeFrame: RVEDA/LVEDA monitoring was performed 1 day after APRV mechanical ventilation
measure: Pulmonary circulatory resistance (PVR)
timeFrame: PVR monitoring was performed 1 day after APRV mechanical ventilation
Secondary outcomes:
measure: Heart rate (HR)
timeFrame: HR monitoring was performed before APRV mechanical ventilation and 6 hours, 12 hours, Day 1, Day 2, Day 3 after APRV mechanical ventilation, and 24 hours after APRV ended
measure: Systolic blood pressure (SBP)
timeFrame: SBP monitoring was performed before APRV mechanical ventilation and 6 hours, 12 hours, Day 1, Day 2, Day 3 after APRV mechanical ventilation, and 24 hours after APRV ended
measure: Mean arterial pressure (MAP)
timeFrame: MAP monitoring was performed before APRV mechanical ventilation and 6 hours, 12 hours, Day 1, Day 2, Day 3 after APRV mechanical ventilation, and 24 hours after APRV ended
measure: cardiac output (CO)
timeFrame: CO monitoring was performed before APRV mechanical ventilation and 6 hours, 12 hours, Day 1, Day 2, Day 3 after APRV mechanical ventilation, and 24 hours after APRV ended by ultrasound
measure: Stroke volume (SV)
timeFrame: SV monitoring was performed before APRV mechanical ventilation and 6 hours, 12 hours, Day 1, Day 2, Day 3 after APRV mechanical ventilation, and 24 hours after APRV ended by ultrasound
measure: 28-day mortality
timeFrame: Day 28 after study entry
measure: The number of days in ICU
timeFrame: From the day subjects entered ICU to the day left ICU(up to 90 days)
measure: The number of days in hospital
timeFrame: From the day subjects entered hospital to the day left hospital including death(up to 90 days)
measure: in-hospital mortality
timeFrame: From the day patients admitted to hospital to the day death or discharge(up to 90 days)
measure: Sequential Organ Failure Assessment score
timeFrame: Within 2 hours admission to ICU and 24 hours after inclusion in the study
measure: Acute Physiology and Chronic Health Evaluation II score
timeFrame: Within 2 hours admission to ICU and 24 hours after inclusion in the study
measure: the effect of APRV ventilation time on right ventricular area fractional change (RV FAC) in ARDS patients
timeFrame: RV FAC monitoring was performed before APRV mechanical ventilation and 6 hours, 12 hours, Day 1, Day 2, Day 3 after APRV mechanical ventilation, and 24 hours after APRV ended by ultrasound
measure: the effect of APRV ventilation time on tricuspid annular systolic displacement (TAPSE) in ARDS patients.
timeFrame: TAPSE monitoring was performed before APRV mechanical ventilation and 6 hours, 12 hours, Day 1, Day 2, Day 3 after APRV mechanical ventilation, and 24 hours after APRV ended by ultrasound
measure: the effect of APRV ventilation time on tricuspid annular systolic S' velocity in ARDS patients.
timeFrame: Tricuspid annular systolic S' velocity monitoring was performed before APRV mechanical ventilation and 6 hours, 12 hours, Day 1, Day 2, Day 3 after APRV mechanical ventilation, and 24 hours after APRV ended by ultrasound
measure: the effect of APRV ventilation time on right ventricular end-diastolic area/left ventricular end-diastolic area (RVEDA/LVEDA) in ARDS patients.
timeFrame: RVEDA/LVEDA monitoring was performed before APRV mechanical ventilation and 6 hours, 12 hours, Day 1, Day 2, Day 3 after APRV mechanical ventilation, and 24 hours after APRV ended by ultrasound
Other outcomes:
Locations:
city: Wuhan
country: China
facility: Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
state: Hubei
Study officials:
affiliation: Wuhan Union Hospital, China
name: xiaojing zou, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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