Effect of APRV and LTV on Lung Ventilation and Perfusion in Patients With Moderate-to-severe ARDS

NCT05767125 | Unknown

• 1 other identifier: WUHICU202302
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

Low tidal volume ventilation (LTV) has been proposed and widely used in patients with acute respiratory distress syndrome (ARDS) to prevent ventilator-induced lung injury (VILI) and mitigate its effects. The LTV strategy is intended to protect the "baby lung" from overdistension while simultaneously allowing acutely injured tissue to continually collapse. Airway pressure release ventilation (APRV) is a highly effective strategy improving lung recruitment and oxygenation in clinical studies, but its effects on lung injury and mortality is debatable. Animal studies revealed that APRV could normalize post-injury heterogeneity and reduce the risk of VILI. Our objective was to investigate the impact of APRV and LTV on regional ventilation and perfusion distribution in ARDS patients by electrical impedance tomography (EIT).

Conditions

Acute Respiratory Distress Syndrome

Outcome Measures

Primary Outcomes (1)

• Lung ventilation/perfusion matching

  Lung ventilation/perfusion matching assessed by EIT

  24hour

Secondary Outcomes (11)

• Lung ventilation distrubution

  up to 72hour

• Lung perfusion distrubution

  up to 72hour

• Dead-space% and shunting%

  up to 72hour

• Oxygenation index

  up to 72hour

• Arterial partial pressure of carbon dioxide (PaCO2)

  up to 72hour

Study Arms (2)

APRV Group

EXPERIMENTAL

Patients with moderate-to-severe ARDS were supported with APRV.

Device: APRV

LTV Group

ACTIVE COMPARATOR

Patients with moderate-to-severe ARDS were supported with LTV.

Device: LTV

Interventions

APRV DEVICE

Patients with moderate-to-severe ARDS were supported with APRV.

APRV Group

LTV DEVICE

Patients with moderate-to-severe ARDS were supported with LTV.

LTV Group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients aged ≥18 and ≤80 years;
• Moderate-to-severe ARDS patients according to the Berlin definition;
• Endotracheal mechanical ventilation ≤48 h before enrollment;
• Expected to require continuous invasive mechanical ventilation ≥72 h.

You may not qualify if:

• Severe chronic obstructive pulmonary disease, severe asthma, pulmonary bulla, subcutaneous emphysema, mediastinal emphysema, etc;
• Contraindications to the use of electrical impedance tomography (e.g., chest surgical wounds dressing or presence of pacemaker)；
• Pulmonary interstitial lesions；
• End-stage of chronic disease, with an expected survival period of \<6 months；
• Body mass index \>35 kg/m2;
• Refractory shock；
• Intracranial hypertension；
• Pregnant and parturient woman；
• Intra-abdominal pressure persisted \> 20 mmHg and could not be relieved within 24 hours；
• Severe thoracic deformity；
• Severe cardiac dysfunction；
• Atrial fibrillation and other malignant arrhythmias that seriously affect cardiac output；
• Pulmonary embolism；
• Extracorporeal membrane oxygenation is needed；
• Prone positioning was performed before randomization；

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 (1)

• Zou X, Zhang H, Wu Y, Li R, Gao X, Wang A, Zhao X, Yang X, Shu H, Qi H, Fu Z, Yuan S, Ma Y, Yang L, Shang Y, Zhao Z. Physiologic Comparison of Airway Pressure Release Ventilation and Low Tidal Volume Ventilation in ARDS: A Randomized Controlled Trial. Chest. 2025 Feb;167(2):453-465. doi: 10.1016/j.chest.2024.08.050. Epub 2024 Sep 17.

  PMID: 39299389 DERIVED

MeSH Terms

Conditions

Respiratory Distress Syndrome

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Respiration Disorders

Study Officials

• You Shang, prof.

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

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Xiaojing Zou, prof.

CONTACT

+862785351606; 249126734@qq.com

You Shang, prof.

CONTACT

+862785351607; you_shanghust@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor

Study Record Dates

• First Submitted: February 16, 2023
• First Posted: March 14, 2023
• Study Start: January 1, 2023
• Primary Completion: December 31, 2024
• Study Completion: December 31, 2024
• Last Updated: March 14, 2023

Record last verified: 2023-03

Locations

CN (1)