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

• Sponsor: Wuhan Union Hospital, China (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT05767125
• Collaborator: (none)
• Enrollment: 40
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 24
• Patients Per Site Per Month: 1.7

Study Details

Study Description

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).

Condition or Disease	Intervention/Treatment	Phase
Acute Respiratory Distress Syndrome	Device: APRV; Device: LTV	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 40 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Effect of APRV and LTV on Lung Ventilation and Perfusion in Patients With Moderate-to-severe ARDS: a Single-center, Pilot Randomized Controlled Study
• Actual Study Start Date: Jan 1, 2023
• Anticipated Primary Completion Date: Dec 31, 2024
• Anticipated Study Completion Date: Dec 31, 2024

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

1. Lung ventilation/perfusion matching [24hour]

   Lung ventilation/perfusion matching assessed by EIT

Secondary Outcome Measures

1. Lung ventilation distrubution [up to 72hour]

   Lung ventilation distrubution assessed by EIT

2. Lung perfusion distrubution [up to 72hour]

   Lung perfusion distrubution assessed by EIT

3. Dead-space% and shunting% [up to 72hour]

   Lung Dead-space% and shunting% assessed by EIT

4. Oxygenation index [up to 72hour]

   Oxygenation index=Arterial partial pressure of oxygen /fraction of inspired oxygen

5. Arterial partial pressure of carbon dioxide (PaCO2) [up to 72hour]

   PaCO2 is one of the key indicators of pulmonary ventilation which can be obtained from arterial blood gas analysis.

6. Static respiratory compliance (Crs) [up to 72hour]

   Crs=tidal volume/driving pressure

7. Cardiac output [up to 72hour]

   Cardiac output assessed by echocardiography

8. Right ventricular function [up to 72hour]

   Right ventricular function assessed by echocardiography

9. Ventilator free days [up to 28days]

   28d-ventilator free days after randomization

10. Duration of Intensive care units stay [up to 28days]

    28d-duration of Intensive care units stay after randomization

11. Mortality after randomization [up to 28days]

    28d-all-cause mortality

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 80 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Union Hospital, Tongji Medical College, Huazhong University of Science and Technology	Wuhan	Hubei	China	430000

Sponsors and Collaborators

• Wuhan Union Hospital, China

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: XiaoJing Zou,MD, Clinical Professor, Wuhan Union Hospital, China
• ClinicalTrials.gov Identifier: NCT05767125
• Other Study ID Numbers: WUHICU202302
• First Posted: Mar 14, 2023
• Last Update Posted: Mar 14, 2023
• Last Verified: Mar 1, 2023

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Respiratory Distress Syndrome; Respiratory Distress Syndrome, Newborn; Acute Lung Injury

Study Results

No Results Posted as of Mar 14, 2023