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

Not Applicable

Recruiting

• Conditions: ARDS
• Interventions: Other: Time-controlled adaptative ventilation (TCAV); Other: Volume-controlled ventilation (VCV)

• Registration Number: NCT05874973
• Lead Sponsor: Central Hospital, Nancy, France

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-05-16
• Study First Submitted QC: 2023-05-24
• Study First Posted: 2023-05-25
• Study Start: 2023-10-25
• Status Verified: 2024-02
• Last Update Submitted: 2024-02-06
• Last Update Posted: 2024-02-07
• Primary Completion: 2024-06-30
• Study Completion: 2024-12-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 33

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Time-Controlled Adaptative Ventilation (TCAV)	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.
Volume Control Ventilation (VCV)	Volume-controlled 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.

Primary Outcome Measures

Name	Time	Method
Percentage of end-expiratory non aerated lung parenchyma	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 Outcome Measures

Name	Time	Method
Atelectrauma in TCAV and VCV	10 minutes	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 %.
Correlation between transpulmonary driving pressure and tidal hyperinflation in TCAV	10 minutes	Area under ROC curve of transpulmonary driving pressure to detect cyclic hyperinflation
End-inspiratory overdistention in TCAV	10 minutes	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.
Tidal hyperinflation in TCAV	10 minutes	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
Correlation between driving pressure and tidal hyperinflation in TCAV	10 minutes	Area under ROC curve of driving pressure to detect cyclic hyperinflation

Trial Locations

Locations (1)

CHRU; 🇫🇷 Nancy, France