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

ARDS Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05414110
• Other study ID #: TTEC20220103
• Status: Recruiting
• Start date: April 3, 2022
• Est. completion date: February 15, 2024

Study information

• Verified date: June 2022
• Source: Wuhan Union Hospital, China
• Contact: xin zhao, master
• Phone: 15927336285
• Email: 619641364[@]qq.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: February 15, 2024
• Est. primary completion date: February 15, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

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

Locations

Country	Name	City	State
China	Union Hospital, Tongji Medical College, Huazhong University of Science and Technology	Wuhan	Hubei

Sponsors (1)

Lead Sponsor	Collaborator
Wuhan Union Hospital, China

Country where clinical trial is conducted

China, 

References & Publications (7)

Boissier F, Katsahian S, Razazi K, Thille AW, Roche-Campo F, Leon R, Vivier E, Brochard L, Vieillard-Baron A, Brun-Buisson C, Mekontso Dessap A. Prevalence and prognosis of cor pulmonale during protective ventilation for acute respiratory distress syndrom — View Citation

Dong D, Zong Y, Li Z, Wang Y, Jing C. Mortality of right ventricular dysfunction in patients with acute respiratory distress syndrome subjected to lung protective ventilation: A systematic review and meta-analysis. Heart Lung. 2021 Sep-Oct;50(5):730-735. — View Citation

Jardin F, Vieillard-Baron A. Right ventricular function and positive pressure ventilation in clinical practice: from hemodynamic subsets to respirator settings. Intensive Care Med. 2003 Sep;29(9):1426-34. Epub 2003 Aug 9. Review. — View Citation

Mekontso Dessap A, Boissier F, Charron C, Bégot E, Repessé X, Legras A, Brun-Buisson C, Vignon P, Vieillard-Baron A. Acute cor pulmonale during protective ventilation for acute respiratory distress syndrome: prevalence, predictors, and clinical impact. In — View Citation

Sun X, Liu Y, Li N, You D, Zhao Y. The safety and efficacy of airway pressure release ventilation in acute respiratory distress syndrome patients: A PRISMA-compliant systematic review and meta-analysis. Medicine (Baltimore). 2020 Jan;99(1):e18586. doi: 10 — View Citation

Zhang H, Huang W, Zhang Q, Chen X, Wang X, Liu D; Critical Care Ultrasound Study Group. Prevalence and prognostic value of various types of right ventricular dysfunction in mechanically ventilated septic patients. Ann Intensive Care. 2021 Jul 13;11(1):108 — View Citation

Zhou Y, Jin X, Lv Y, Wang P, Yang Y, Liang G, Wang B, Kang Y. Early application of airway pressure release ventilation may reduce the duration of mechanical ventilation in acute respiratory distress syndrome. Intensive Care Med. 2017 Nov;43(11):1648-1659. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Right ventricular area fractional change (RV FAC)	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%.	RV FAC monitoring was performed 1 day after APRV mechanical ventilation
Primary	Tricuspid annular systolic displacement(TAPSE)	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.	TAPSE monitoring was performed 1 day after APRV mechanical ventilation
Primary	Tricuspid annular systolic S' velocity (TS')	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).	TS' monitoring was performed 1 day after APRV mechanical ventilation
Primary	Right ventricular end-diastolic area/left ventricular end-diastolic area (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 left ventricular(LV) end-systolic area (LVEDA) were measured on the apical four-chamber section by two-dimensional ultrasound.	RVEDA/LVEDA monitoring was performed 1 day after APRV mechanical ventilation
Primary	Pulmonary circulatory resistance (PVR)	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.	PVR monitoring was performed 1 day after APRV mechanical ventilation
Secondary	Heart rate (HR)	HR is a basic element of hemodynamic index	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
Secondary	Systolic blood pressure (SBP)	SBP is basic element of hemodynamic index	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
Secondary	Mean arterial pressure (MAP)	MAP represents peripheral organ perfusion pressure	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
Secondary	cardiac output (CO)	CO is an important parameter to reflect the cardiac function of patients	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
Secondary	Stroke volume (SV)	Stroke volume is the amount of blood that the ventricle shoots out during a single heart beat.	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
Secondary	28-day mortality	28-day mortality after study entry	Day 28 after study entry
Secondary	The number of days in ICU	The number of days in ICU(up to 90 days)	From the day subjects entered ICU to the day left ICU(up to 90 days)
Secondary	The number of days in hospital	The number of days in hospital(up to 90 days)	From the day subjects entered hospital to the day left hospital including death(up to 90 days)
Secondary	in-hospital mortality	Any death occurred during hospitalization(up to 90 days)	From the day patients admitted to hospital to the day death or discharge(up to 90 days)
Secondary	Sequential Organ Failure Assessment score	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).	Within 2 hours admission to ICU and 24 hours after inclusion in the study
Secondary	Acute Physiology and Chronic Health Evaluation II score	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.	Within 2 hours admission to ICU and 24 hours after inclusion in the study
Secondary	the effect of APRV ventilation time on right ventricular area fractional change (RV FAC) in ARDS patients	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%.	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
Secondary	the effect of APRV ventilation time on tricuspid annular systolic displacement (TAPSE) in ARDS patients.	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.	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
Secondary	the effect of APRV ventilation time on tricuspid annular systolic S' velocity in ARDS patients.	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).	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
Secondary	the effect of APRV ventilation time on right ventricular end-diastolic area/left ventricular end-diastolic area (RVEDA/LVEDA) in ARDS patients.	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.	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