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

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

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

Study Overview

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

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 Type: Observational
• Enrollment (Anticipated): 50

Contacts and Locations

• Study Contact: Name: xin zhao, master; Phone Number: 027-85351607 15927336285; Email: 619641364@qq.com
• Study Contact Backup: Name: xiaojing zou, PhD; Phone Number: 027-85351607 13995518630; Email: 249126734@qq.com

Study Locations

• China
  • Hubei
    • Wuhan, Hubei, China, 430000
      • Recruiting
      • Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
      • Contact: xin zhao, master; Phone Number: 027-85351607 15927336285; Email: 619641364@qq.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Include as many eligible study populations as possible by study protocol

Description

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 Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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
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
28-day mortality	28-day mortality after study entry	Day 28 after study entry
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)
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)
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)
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
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
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
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
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
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

Collaborators and Investigators

• Sponsor: Wuhan Union Hospital, China
• Investigators: Principal Investigator: xiaojing zou, PhD, Wuhan Union Hospital, China

Publications and helpful links

General Publications

• 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. doi: 10.1186/s13613-021-00902-9.
• 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 syndrome. Intensive Care Med. 2013 Oct;39(10):1725-33. doi: 10.1007/s00134-013-2941-9. Epub 2013 May 15.
• 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. doi: 10.1016/j.hrtlng.2021.04.011. Epub 2021 Jun 9.
• Mekontso Dessap A, Boissier F, Charron C, Begot E, Repesse 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. Intensive Care Med. 2016 May;42(5):862-870. doi: 10.1007/s00134-015-4141-2. Epub 2015 Dec 9.
• 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. doi: 10.1007/s00134-003-1873-1. Epub 2003 Aug 9. No abstract available.
• 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: 10.1097/MD.0000000000018586.
• 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. doi: 10.1007/s00134-017-4912-z. Epub 2017 Sep 22.

Study record dates

Study Major Dates

• Study Start (Actual): April 3, 2022
• Primary Completion (Anticipated): February 15, 2024
• Study Completion (Anticipated): February 15, 2024

Study Registration Dates

• First Submitted: April 5, 2022
• First Submitted That Met QC Criteria: June 7, 2022
• First Posted (Actual): June 10, 2022

Study Record Updates

• Last Update Posted (Actual): June 10, 2022
• Last Update Submitted That Met QC Criteria: June 7, 2022
• Last Verified: June 1, 2022

More Information

Terms related to this study

• Other Study ID Numbers: TTEC20220103

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No