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Clinical Trials/NCT05874973
NCT05874973
Recruiting
Not Applicable

Effects of Time-controlled Adaptive Ventilation (TCAV) and Volume Control Ventilation (VCV) on the Distribution of Aerated Lung Parenchyma in Patients With Acute Respiratory Distress Syndrome (ARDS): a Pilot Study

Central Hospital, Nancy, France1 site in 1 country33 target enrollmentOctober 25, 2023
ConditionsARDS

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
ARDS
Sponsor
Central Hospital, Nancy, France
Enrollment
33
Locations
1
Primary Endpoint
Percentage of end-expiratory non aerated lung parenchyma
Status
Recruiting
Last Updated
2 years ago

Overview

Brief Summary

Acute respiratory distress syndrome (ARDS) is a severe form of acute respiratory failure with mortality rates reaching as high as 35%. Management of ARDS is based on the treatment (if possible) of the underlying cause of ARDS and on invasive mechanical ventilation with positive expiratory pressure (PEEP). Another strategy of invasive ventilation, Time-Controlled Adaptative Ventilation (TCAV), is the application of specific settings to the airway pressure release ventilation (APRV) mode.

TCAV is based on a prolonged time at plateau pressure, creating a phase of continuous positive pressure, associated with brief release phases allowing the elimination of carbon dioxide. In prospective and retrospective clinical reviews, as well as in experimental animal studies, TCAV has demonstrated improvements in oxygenation and lung function, with the ability to prevent ARDS.

The thoracic computed tomography (CT) scan evaluates lung recruitment (re-aeration by positive pressure of non-ventilated lung territories) and the adverse effects of positive pressure on the parenchyma (hyperinflation).

The objective of this study is to evaluate, with CT scans performed to assess lungs of patients with ARDS, the effects of TCAV compared to a standard volumetric controlled ventilation, by measuring alveolar recruitment and over-distension.

Registry
clinicaltrials.gov
Start Date
October 25, 2023
End Date
December 30, 2024
Last Updated
2 years ago
Study Type
Interventional
Study Design
Crossover
Sex
All

Investigators

Sponsor
Central Hospital, Nancy, France
Responsible Party
Principal Investigator
Principal Investigator

PEQUIGNOT Benjamin

Dr

Central Hospital, Nancy, France

Eligibility Criteria

Inclusion Criteria

  • ARDS according to the Berlin definition
  • invasive ventilation for no longer than 72 hours
  • patient requiring a diagnostic thoracic CT scan
  • consent of a family member or the person of trust
  • social security affiliation

Exclusion Criteria

  • Use of iodinated contrast media injection before CT acquisitions
  • ARDS criteria present during 72 hours or more
  • Severe COPD
  • Pneumothorax or other barotrauma-related complication
  • Right ventricular failure other than acute cor pulmonale
  • Absence of sedative agents and neuromuscular blockade
  • Severe hemodynamic instability (norepinephrine \> 0.5 µg/kg/min)
  • VA-ECMO assistance
  • Pregnancy
  • Absence of the capacity to give consent before admission to the ICU

Outcomes

Primary Outcomes

Percentage of end-expiratory non aerated lung parenchyma

Time Frame: during procedure (10 minutes)

Percentage of non aerated lung parenchyma defined as % of lung at -100 to +100 Hounsfield Units (HU) divided by total lung weight, at the end of expiration.

Secondary Outcomes

  • Correlation between transpulmonary driving pressure and tidal hyperinflation in TCAV(10 minutes)
  • End-inspiratory overdistention in TCAV(10 minutes)
  • Tidal hyperinflation in TCAV(10 minutes)
  • Correlation between driving pressure and tidal hyperinflation in TCAV(10 minutes)
  • Atelectrauma in TCAV and VCV(10 minutes)

Study Sites (1)

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