Effect of Airway Pressure Release Ventilation on Right Ventricular Function Assessed by Transthoracic Echocardiography

• Conditions: ARDS; Transthoracic Echocardiography; Ventilation Therapy; Complications; Right Ventricular Function

• Registration Number: NCT05414110
• Lead Sponsor: Wuhan Union Hospital, China

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.

Study Timeline

• Study Start: 2022-04-03
• Study First Submitted: 2022-04-05
• Status Verified: 2022-06
• Study First Submitted QC: 2022-06-07
• Last Update Submitted: 2022-06-07
• Study First Posted: 2022-06-10
• Last Update Posted: 2022-06-10
• Primary Completion: 2024-02-15
• Study Completion: 2024-02-15

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 50

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Right ventricular area fractional change (RV FAC)	RV FAC monitoring was performed 1 day after APRV mechanical ventilation	Right ventricular area fractional change (RV FAC)is a simple and repeatable ultrasound method for evaluating RV function. Methods: The RV end-diastolic area (RVEDA) and RV end-systolic area (RVESA) were measured on the apical four-chamber section by two-dimensional ultrasound. RV FAC=(RVEDA- RVESA)/RVEDA\*100%.
Tricuspid annular systolic displacement(TAPSE)	TAPSE monitoring was performed 1 day after APRV mechanical ventilation	TAPSE:TAPSE is one of the most effective ultrasound methods for evaluating right ventricular function.Measurement method: TAPSE was measured on the four-chamber section of the apex of the heart by M-mode ultrasound. the sampling line was placed at the side wall of the tricuspid valve ring, parallel to the free wall of the right ventricle as far as possible, and the displacement of the tricuspid valve ring was measured from the end of diastole to the end of systole.
Tricuspid annular systolic S' velocity (TS')	TS' monitoring was performed 1 day after APRV mechanical ventilation	TS' is an objective and accurate ultrasound technique for evaluating right ventricular function.Measurement method:The sample volume was applied to the free wall of the RV and the peak velocity of tricuspid annulus motion was measured in the four-chamber section of the apex by tissue doppler imaging (TDI).
Right ventricular end-diastolic area/left ventricular end-diastolic area (RVEDA/LVEDA)	RVEDA/LVEDA monitoring was performed 1 day after APRV mechanical ventilation	RVEDA/LVEDA a simple and repeatable ultrasound method for evaluating dynamics changes of RV function.Methods: The RV end-diastolic area (RVEDA) and left ventricular(LV) end-systolic area (LVEDA) were measured on the apical four-chamber section by two-dimensional ultrasound.
Pulmonary circulatory resistance (PVR)	PVR monitoring was performed 1 day after APRV mechanical ventilation	Increased PVR can lead to deterioration of RV function.Pulse Doppler imaging (PWD) was used to obtain the pulmonary artery flow spectrum from the pulmonic valve on the short axial section of the parasternal great vessels.

Secondary Outcome Measures

Name	Time	Method
28-day mortality	Day 28 after study entry	28-day mortality after study entry
Heart rate (HR)	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	HR is a basic element of hemodynamic index
Systolic blood pressure (SBP)	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	SBP is basic element of hemodynamic index
Mean arterial pressure (MAP)	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	MAP represents peripheral organ perfusion pressure
cardiac output (CO)	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	CO is an important parameter to reflect the cardiac function of patients
Stroke volume (SV)	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	Stroke volume is the amount of blood that the ventricle shoots out during a single heart beat.
The number of days in ICU	From the day subjects entered ICU to the day left ICU(up to 90 days)	The number of days in ICU(up to 90 days)
The number of days in hospital	From the day subjects entered hospital to the day left hospital including death(up to 90 days)	The number of days in hospital(up to 90 days)
in-hospital mortality	From the day patients admitted to hospital to the day death or discharge(up to 90 days)	Any death occurred during hospitalization(up to 90 days)
Sequential Organ Failure Assessment score	Within 2 hours admission to ICU and 24 hours after inclusion in the study	The higher the Sequential Organ Failure Assessment(SOFA) score, the higher the disease risk factor and the higher the mortality rate(The highest score is 24, while the lowest score is 0).
Acute Physiology and Chronic Health Evaluation II score	Within 2 hours admission to ICU and 24 hours after inclusion in the study	The higher the Acute Physiology and Chronic Health Evaluation II(APACHE II) score, the higher the disease risk factor and the higher the mortality rate(the highest score is 71, while the lowest score is 0).In particular, the accuracy of group patient prediction is high.
the effect of APRV ventilation time on right ventricular area fractional change (RV FAC) in ARDS patients	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	The RV end-diastolic area (RVEDA) and RV end- systolic area (RVESA) were measured on the apical four-chamber section by two-dimensional ultrasound. RV FAC=(RVEDA- RVESA)/RVEDA\*100%.
the effect of APRV ventilation time on tricuspid annular systolic displacement (TAPSE) in ARDS patients.	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	TAPSE was measured on the four-chamber section of the apex of the heart by M-mode ultrasound. the sampling line was placed at the side wall of the tricuspid valve ring, parallel to the free wall of the right ventricle as far as possible, and the displacement of the tricuspid valve ring was measured from the end of diastole to the end of RV systole.
the effect of APRV ventilation time on tricuspid annular systolic S' velocity in ARDS patients.	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	Tricuspid annular systolic S' velocity is an objective and accurate ultrasound technique for evaluating right ventricular function.Measurement method:The sample volume was applied to the free wall of the RV and the peak velocity of tricuspid annulus motion was measured in the four-chamber section of the apex by tissue doppler imaging (TDI).
the effect of APRV ventilation time on right ventricular end-diastolic area/left ventricular end-diastolic area (RVEDA/LVEDA) in ARDS patients.	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	RVEDA/LVEDA：RVEDA/LVEDA a simple and repeatable ultrasound method for evaluating dynamics changes of RV function.Methods: The RV end-diastolic area (RVEDA) and LV end-systolic area (lVEDA) were measured on the apical four-chamber section by two-dimensional ultrasound.

Trial Locations

Locations (1)

Union Hospital, Tongji Medical College, Huazhong University of Science and Technology; 🇨🇳 Wuhan, Hubei, China