Effect of APRV vs. LTV on Right Heart Function in ARDS Patients: a Single-center Randomized Controlled Study

NCT05922631 | Completed

• 1 other identifier: ALRVD2022
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

Acute Respiratory Distress Syndrome (ARDS) is often complicated by Right Ventricular Dysfunction (RVD), and the incidence can be as high as 64%. The mechanism includes pulmonary vascular dysfunction and right heart systolic dysfunction. Pulmonary vascular dysfunction includes acute vascular inflammation, pulmonary vascular edema, thrombosis and pulmonary vascular remodeling. Alveolar collapse and over distension can also lead to increased pulmonary vascular resistance, Preventing the development of acute cor pulmonale in patients with acute respiratory distress. ARDS patients with RVD have a worse prognosis and a significantly increased risk of death, which is an independent risk factor for death in ARDS patients. Therefore, implementing a right heart-protective mechanical ventilation strategy may reduce the incidence of RVD. APRV is an inverse mechanical ventilation mode with transient pressure release under continuous positive airway pressure, which can effectively improve oxygenation and reduce ventilator-associated lung injury. However, its effect on right ventricular function is still controversial. Low tidal volume (LTV) is a mechanical ventilation strategy widely used in ARDS patients. Meta-analysis results showed that compared with LTV, APRV improved oxygenation more significantly, reduced the time of mechanical ventilation, and even had a tendency to improve the mortality of ARDS patients However, randomized controlled studies have shown that compared with LTV, APRV improves oxygenation more significantly and also increases the mean airway pressure. Therefore, some scholars speculate that APRV may increase the intrathoracic pressure, pulmonary circulatory resistance, and the risk of right heart dysfunction but this speculation is not supported by clinical research evidence. In addition, APRV may improve right ventricular function by correcting hypoxia and hypercapnia, promoting lung recruitment and reducing pulmonary circulation resistance. Therefore, it is very important to clarify this effect for whether APRV can be safely used and popularized in clinic.we aim to conduct a single-center randomized controlled study to further compare the effects of APRV and LTV on right ventricular function in patients with ARDS, pulmonary circulatory resistance (PVR) right ventricular-pulmonary artery coupling (RV-PA coupling), and pulmonary vascular resistance (PVR).

Conditions

Right Heart Failure; Mechanical Ventilation; Acute Respiratory Distress Syndrome

Outcome Measures

Primary Outcomes (1)

• Incidence of right heart dysfunction in ARDS patients with APRV or LTV mechanical ventilation for 24h

  Incidence of right heart dysfunction in ARDS patients with APRV or LTV mechanical ventilation for 24h.Abnormal findings on any of the following ultrasound measures can be considered as right ventricular dysfunction, including: tricuspid annular plane systolic excursion (TAPSE) \<17 mm, tricuspid annular plane systolic velocity (S') \<9.5 cm/s, right ventricular fractional area change (FAC) \<35%, ratio of right ventricular end-diastolic area to left ventricular end-diastolic area (RVEDA/LVEDA) \>0.6, or right ventricular to left ventricular end-diastolic diameter ratio (RV/LV ratio) \>1.

  at the time of 24 hours after inclusion

Secondary Outcomes (31)

• Incidence of right heart dysfunction in ARDS patients with APRV or LTV mechanical ventilation for 48h

  at the time of 48 hours after inclusion

• Incidence of right heart dysfunction in ARDS patients with APRV or LTV mechanical ventilation for 72h

  at the time of 72 hours after inclusion

• Values of tricuspid annular plane systolic excursion at 24th hour

  at the time of 24 hours after inclusion

• Values of tricuspid annular plane systolic excursion at 48th hour

  at the time of 48 hours after inclusion

• Values of tricuspid annular plane systolic excursion at 72th hour

  at the time of 72 hours after inclusion

Study Arms (2)

APRV group

EXPERIMENTAL

In APRV group, ventilator parameters were set according to the study protocol, P high: Tidal volume (VT) was set at 6ml/kg of ideal body weight, and plateau pressure (Pplat) was measured. Initial Phigh was set at Pplat, usually 20-32 cmH2O. The APRV end-expiratory flow rate was set at 75% of the peak expiratory flow rate.

Procedure: Airway pressure release ventilation

LTV group

PLACEBO COMPARATOR

The ARDSnet method was used for LTV group mechanical ventilation, and the tidal volume was set according to 4-8ml/kg, so that the Pplat was \<30cmH2O

Procedure: low tidal volume

Interventions

Airway pressure release ventilation PROCEDURE

ventilator parameters were set according to the study protocol, P high: Tidal volume (VT) was set at 6ml/kg of ideal body weight, and plateau pressure (Pplat) was measured. Initial Phigh was set at Pplat, usually 20-32 cmH2O. The APRV end-expiratory flow rate was set at 75% of the peak expiratory flow rate.

APRV group

low tidal volume PROCEDURE

The ARDSnet method was used for LTV mechanical ventilation, and the tidal volume was set according to 4-8ml/kg, so that the Pplat was \<30cmH2O

LTV group

Eligibility Criteria

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

You may not qualify if:

• abdominal pressure≥20mmHg 2.BMI≥35kg/m2; 3. pregnant and lactating women 4.expected duration of invasive mechanical ventilation \< 72 hours 5. neuromuscular diseases known to require prolonged mechanical ventilation 6.severe chronic obstructive pulmonary disease, severe asthma, Interstitial lung disease 7.intracranial hypertension, 8.pulmonary bullae or pneumothorax, subcutaneous emphysema, or mediastinal emphysema, 9.extracorporeal membrane oxygenation or prone position ventilation on admission to the ICU 10. uncorrected shock of various types and refractory shock 11.pulmonary embolism 12.severe cardiac dysfunction (New York Heart Association class III or IV). Acute coronary syndrome or sustained ventricular tachyarrhythmia), right heart enlargement due to chronic cardiopulmonary diseases, cardiogenic shock or after major cardiac surgery 13.poor cardiac sound window, unable to obtain cardiac ultrasound images 14.no informed consent was signed

Sponsors & Collaborators

• XiaoJing Zou,MD: lead

Study Sites (1)

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

Wuhan, Hubei, 430000, China

Location

Related Publications (10)

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• Sipmann FS, Santos A, Tusman G. Heart-lung interactions in acute respiratory distress syndrome: pathophysiology, detection and management strategies. Ann Transl Med. 2018 Jan;6(2):27. doi: 10.21037/atm.2017.12.07.

  PMID: 29430444 BACKGROUND

• Cheng J, Ma A, Dong M, Zhou Y, Wang B, Xue Y, Wang P, Yang J, Kang Y. Does airway pressure release ventilation offer new hope for treating acute respiratory distress syndrome? J Intensive Med. 2022 Mar 28;2(4):241-248. doi: 10.1016/j.jointm.2022.02.003. eCollection 2022 Oct.

  PMID: 36785647 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• Andrews P, Shiber J, Madden M, Nieman GF, Camporota L, Habashi NM. Myths and Misconceptions of Airway Pressure Release Ventilation: Getting Past the Noise and on to the Signal. Front Physiol. 2022 Jul 25;13:928562. doi: 10.3389/fphys.2022.928562. eCollection 2022.

  PMID: 35957991 BACKGROUND

• Robinson B, Ebeid M. A simple echocardiographic method to estimate pulmonary vascular resistance. Am J Cardiol. 2014 Jan 15;113(2):412. doi: 10.1016/j.amjcard.2013.11.001. Epub 2013 Nov 7. No abstract available.

  PMID: 24387904 BACKGROUND

MeSH Terms

Conditions

Heart Failure; Respiratory Distress Syndrome

Interventions

Continuous Positive Airway Pressure

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Lung Diseases; Respiratory Tract Diseases; Respiration Disorders

Intervention Hierarchy (Ancestors)

Positive-Pressure Respiration; Respiration, Artificial; Airway Management; Therapeutics; Respiratory Therapy

Study Officials

• Xiaojing zou, MD

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

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: participants are blinded to accept APRV or LTV after inclusion.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Clinical Professor

Model Details: Patients with ARDS who met the inclusion criteria were randomized to APRV or LTV mechanical ventilation. Ventilator parameters were set according to the study protocol, P high: Tidal volume (VT) was set at 6ml/kg of ideal body weight, and plateau pressure (Pplat) was measured. Initial Phigh was set at Pplat, usually 20-32 cmH2O. The APRV end-expiratory flow rate was set at 75% of the peak expiratory flow rate. For LTV mechanical ventilation, ARDSnet method was used to set the tidal volume according to 4-8ml/kg, so that Pplat\<30cmH2O

Study Record Dates

• First Submitted: June 19, 2023
• First Posted: June 28, 2023
• Study Start: July 3, 2023
• Primary Completion: February 1, 2025
• Study Completion: February 1, 2025
• Last Updated: September 18, 2025

Record last verified: 2025-05

Locations

CN (1)