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

NCT05414110 | Unknown

• 1 other identifier: TTEC20220103
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

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

Outcome Measures

Primary Outcomes (5)

• 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 Outcomes (15)

• 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

• 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

• 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

• 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

• 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

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Include as many eligible study populations as possible by study protocol

You may qualify if:

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

You may not qualify if:

• Aged less than 18 years old or older than 80 years old
• Obese patients with BMI≥35kg/m2;
• Pregnant and lactating women
• The expected time of invasive mechanical ventilation is expected to be less than 48h
• Neuromuscular disease known to require prolonged mechanical ventilation
• Severe chronic obstructive pulmonary disease
• Intracranial hypertension
• Bullae or pneumothorax, subcutaneous emphysema, mediastinal emphysema
• extracorporeal membrane oxygenation(ECMO) has been performed when entering the ICU
• Refractory shock
• 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;
• Failure to sign informed consent

Sponsors & Collaborators

• Union Hospital, Tongji Medical College, Huazhong University of Science and Technology: lead

Study Sites (1)

Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

Wuhan, Hubei, 430000, China

RECRUITING

Related Publications (7)

• 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.

  PMID: 34255224 RESULT

• 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.

  PMID: 23673401 RESULT

• 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.

  PMID: 34118786 RESULT

• 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.

  PMID: 26650055 RESULT

• 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.

  PMID: 12910335 RESULT

• 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.

  PMID: 31895807 RESULT

• 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.

  PMID: 28936695 RESULT

Study Officials

• xiaojing zou, PhD

  Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

  PRINCIPAL INVESTIGATOR

Central Study Contacts

xin zhao, master

CONTACT

15927336285; 619641364@qq.com

xiaojing zou, PhD

CONTACT

13995518630; 249126734@qq.com

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 5, 2022
• First Posted: June 10, 2022
• Study Start: April 3, 2022
• Primary Completion: February 15, 2024
• Study Completion: February 15, 2024
• Last Updated: June 10, 2022

Record last verified: 2022-06

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)