Effects of TCAV and Volume Control Ventilation on the Distribution of Aerated Lung Parenchyma in ARDS Patients (TCAV-CT)

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

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.

Study Overview

• Status: Recruiting
• Conditions: ARDS
• Intervention / Treatment: Other: Time-controlled adaptative ventilation (TCAV); Other: Volume-controlled ventilation (VCV)

• Study Type: Interventional
• Enrollment (Estimated): 33
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Benjamin PEQUIGNOT, MD; Phone Number: +33383153851; Email: b.pequignot@chru-nancy.fr
• Study Contact Backup: Name: Matthieu Koszutski, MD; Phone Number: +3383153017; Email: m.koszutski@chru-nancy.fr

Study Locations

• France
  • Nancy, France
    • Recruiting
    • CHRU
    • Contact: Benjamin PEQUIGNOT, MD; Phone Number: +33383153851; Email: b.pequignot@chru-nancy.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Time-Controlled Adaptative Ventilation (TCAV); APRV mode set with: a Phigh at Plateau Pressure of the VCV mode; a Tlow set to terminate the expiration at 75% of the maximal expiratory flow; a Plow set at 0 cmH2O.; a Thigh set to achieve adequate decarboxylation.	Other: Time-controlled adaptative ventilation (TCAV); Ventilation with TCAV set on the APRV mode on the ventilator.
Active Comparator: Volume Control Ventilation (VCV); Ventilation with the VCV mode set with: a tidal volume (VT) at or below 6 ml/kg of predicted body weight; a positive end-expiratory pressure (PEEP) set at least at 5 cmH2O; a driving pressure lower than 15 cmH2O.	Other: Volume-controlled ventilation (VCV); Ventilation with the VCV mode set on the ventilator.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of end-expiratory non aerated lung parenchyma	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.	during procedure (10 minutes)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
End-inspiratory overdistention in TCAV	Percentage of hyper-aerated lung parenchyma defined as lung volume at ≤ - 901 Hounsfield Units (HU) divided by total lung volume, at the end of inspiration in TCAV.	10 minutes
Tidal hyperinflation in TCAV	Tidal hyperinflation is defined as the volume of the hyper-aerated (density ≤ - 901 HU) compartment at end-inspiration minus hyper-aerated (density ≤ - 901 HU) volume at end-expiration, and standardized to predicted body weight (PBW), expressed in ml/kg of PBW	10 minutes
Atelectrauma in TCAV and VCV	Tidal recruitment of the non-aerated (-100 to +100 Hounsfield Units) compartment was defined as the weight of the non-aerated compartment at end-expiration minus its weight at end-inspiration, and standardized to total lung weight, expressed in %.	10 minutes
Correlation between transpulmonary driving pressure and tidal hyperinflation in TCAV	Area under ROC curve of transpulmonary driving pressure to detect cyclic hyperinflation	10 minutes
Correlation between driving pressure and tidal hyperinflation in TCAV	Area under ROC curve of driving pressure to detect cyclic hyperinflation	10 minutes

Collaborators and Investigators

• Sponsor: Central Hospital, Nancy, France
• Investigators: Principal Investigator: Benjamin Pequignot, Chru Nancy

Study record dates

Study Major Dates

• Study Start (Actual): October 25, 2023
• Primary Completion (Estimated): June 30, 2024
• Study Completion (Estimated): December 30, 2024

Study Registration Dates

• First Submitted: May 16, 2023
• First Submitted That Met QC Criteria: May 24, 2023
• First Posted (Actual): May 25, 2023

Study Record Updates

• Last Update Posted (Actual): February 7, 2024
• Last Update Submitted That Met QC Criteria: February 6, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Keywords: Mechanical Ventilation
• Other Study ID Numbers: 2021PI212

Drug and device information, study documents

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