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

Not Applicable

Recruiting

• Conditions: Acute Respiratory Distress Syndrome
• Interventions: Device: LTV; Device: APRV

• Registration Number: NCT05767125
• Lead Sponsor: Wuhan Union Hospital, China

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).

Detailed Description

Not available

Study Timeline

• Study Start: 2023-01-01
• Study First Submitted: 2023-02-16
• Status Verified: 2023-03
• Study First Submitted QC: 2023-03-01
• Last Update Submitted: 2023-03-01
• Study First Posted: 2023-03-14
• Last Update Posted: 2023-03-14
• Primary Completion: 2024-12-31
• Study Completion: 2024-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 40

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
LTV Group	LTV	Patients with moderate-to-severe ARDS were supported with LTV.
APRV Group	APRV	Patients with moderate-to-severe ARDS were supported with APRV.

Primary Outcome Measures

Name	Time	Method
Lung ventilation/perfusion matching	24hour	Lung ventilation/perfusion matching assessed by EIT

Secondary Outcome Measures

Name	Time	Method
Dead-space% and shunting%	up to 72hour	Lung Dead-space% and shunting% assessed by EIT
Static respiratory compliance (Crs)	up to 72hour	Crs=tidal volume/driving pressure
Cardiac output	up to 72hour	Cardiac output assessed by echocardiography
Ventilator free days	up to 28days	28d-ventilator free days after randomization
Lung perfusion distrubution	up to 72hour	Lung perfusion distrubution assessed by EIT
Lung ventilation distrubution	up to 72hour	Lung ventilation distrubution assessed by EIT
Oxygenation index	up to 72hour	Oxygenation index=Arterial partial pressure of oxygen /fraction of inspired oxygen
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.
Right ventricular function	up to 72hour	Right ventricular function assessed by echocardiography
Duration of Intensive care units stay	up to 28days	28d-duration of Intensive care units stay after randomization
Mortality after randomization	up to 28days	28d-all-cause mortality

Trial Locations

Locations (1)

Union Hospital, Tongji Medical College, Huazhong University of Science and Technology; 🇨🇳 Wuhan, Hubei, China