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Clinical Trials/NCT05767125
NCT05767125
Recruiting
Not Applicable

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

Wuhan Union Hospital, China1 site in 1 country40 target enrollmentJanuary 1, 2023

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Acute Respiratory Distress Syndrome
Sponsor
Wuhan Union Hospital, China
Enrollment
40
Locations
1
Primary Endpoint
Lung ventilation/perfusion matching
Status
Recruiting
Last Updated
3 years ago

Overview

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).

Registry
clinicaltrials.gov
Start Date
January 1, 2023
End Date
December 31, 2024
Last Updated
3 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Wuhan Union Hospital, China
Responsible Party
Principal Investigator
Principal Investigator

XiaoJing Zou,MD

Clinical Professor

Wuhan Union Hospital, China

Eligibility Criteria

Inclusion Criteria

  • 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.

Exclusion Criteria

  • 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;

Outcomes

Primary Outcomes

Lung ventilation/perfusion matching

Time Frame: 24hour

Lung ventilation/perfusion matching assessed by EIT

Secondary Outcomes

  • Dead-space% and shunting%(up to 72hour)
  • Static respiratory compliance (Crs)(up to 72hour)
  • Cardiac output(up to 72hour)
  • Ventilator free days(up to 28days)
  • Lung perfusion distrubution(up to 72hour)
  • Duration of Intensive care units stay(up to 28days)
  • Mortality after randomization(up to 28days)
  • Lung ventilation distrubution(up to 72hour)
  • Oxygenation index(up to 72hour)
  • Arterial partial pressure of carbon dioxide (PaCO2)(up to 72hour)
  • Right ventricular function(up to 72hour)

Study Sites (1)

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