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

Effect of APRV and LTV on Lung Ventilation and Perfusion in Patients With Moderate-to-severe ARDS: a Single-center, Pilot Randomized Controlled Study

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).

Study Overview

• Status: Recruiting
• Conditions: Acute Respiratory Distress Syndrome
• Intervention / Treatment: Device: APRV; Device: LTV

• Study Type: Interventional
• Enrollment (Anticipated): 40
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Xiaojing Zou, prof.; Phone Number: +862785351606; Email: 249126734@qq.com
• Study Contact Backup: Name: You Shang, prof.; Phone Number: +862785351607; Email: you_shanghust@163.com

Study Locations

• China
  • Hubei
    • Wuhan, Hubei, China, 430000
      • Recruiting
      • Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
      • Contact: Yongran WU, master; Phone Number: 027-85351607 18627004016; Email: 974528836@qq.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

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

Exclusion Criteria:

1. Severe chronic obstructive pulmonary disease, severe asthma, pulmonary bulla, subcutaneous emphysema, mediastinal emphysema, etc;
2. Contraindications to the use of electrical impedance tomography (e.g., chest surgical wounds dressing or presence of pacemaker)；
3. Pulmonary interstitial lesions；
4. End-stage of chronic disease, with an expected survival period of <6 months；
5. Body mass index >35 kg/m2;
6. Refractory shock；
7. Intracranial hypertension；
8. Pregnant and parturient woman；
9. Intra-abdominal pressure persisted > 20 mmHg and could not be relieved within 24 hours；
10. Severe thoracic deformity；
11. Severe cardiac dysfunction；
12. Atrial fibrillation and other malignant arrhythmias that seriously affect cardiac output；
13. Pulmonary embolism；
14. Extracorporeal membrane oxygenation is needed；
15. Prone positioning was performed before randomization；
16. Patients who have participated in other clinical trials within 30 days；
17. Patients who have not signed informed consent.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: APRV Group; Patients with moderate-to-severe ARDS were supported with APRV.	Device: APRV; Patients with moderate-to-severe ARDS were supported with APRV.
Active Comparator: LTV Group; Patients with moderate-to-severe ARDS were supported with LTV.	Device: LTV; Patients with moderate-to-severe ARDS were supported with LTV.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Lung ventilation/perfusion matching	Lung ventilation/perfusion matching assessed by EIT	24hour

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Lung ventilation distrubution	Lung ventilation distrubution assessed by EIT	up to 72hour
Lung perfusion distrubution	Lung perfusion distrubution assessed by EIT	up to 72hour
Dead-space% and shunting%	Lung Dead-space% and shunting% assessed by EIT	up to 72hour
Oxygenation index	Oxygenation index=Arterial partial pressure of oxygen /fraction of inspired oxygen	up to 72hour
Arterial partial pressure of carbon dioxide (PaCO2)	PaCO2 is one of the key indicators of pulmonary ventilation which can be obtained from arterial blood gas analysis.	up to 72hour
Static respiratory compliance (Crs)	Crs=tidal volume/driving pressure	up to 72hour
Cardiac output	Cardiac output assessed by echocardiography	up to 72hour
Right ventricular function	Right ventricular function assessed by echocardiography	up to 72hour
Ventilator free days	28d-ventilator free days after randomization	up to 28days
Duration of Intensive care units stay	28d-duration of Intensive care units stay after randomization	up to 28days
Mortality after randomization	28d-all-cause mortality	up to 28days

Collaborators and Investigators

• Sponsor: Wuhan Union Hospital, China
• Investigators: Principal Investigator: You Shang, prof., Wuhan Union Hospital, China

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2023
• Primary Completion (Anticipated): December 31, 2024
• Study Completion (Anticipated): December 31, 2024

Study Registration Dates

• First Submitted: February 16, 2023
• First Submitted That Met QC Criteria: March 1, 2023
• First Posted (Actual): March 14, 2023

Study Record Updates

• Last Update Posted (Actual): March 14, 2023
• Last Update Submitted That Met QC Criteria: March 1, 2023
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Respiration Disorders; Lung Diseases; Infant, Newborn, Diseases; Lung Injury; Infant, Premature, Diseases; Respiratory Distress Syndrome; Respiratory Distress Syndrome, Newborn; Acute Lung Injury
• Other Study ID Numbers: WUHICU202302

Drug and device information, study documents

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