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

Central Hospital, Nancy, France

Status: Enrolling

Conditions: ARDS

Treatments: Other: Volume-controlled ventilation (VCV); Other: Time-controlled adaptative ventilation (TCAV)

Study type: Interventional

Funder types: Other

Identifiers

NCT05874973

2021PI212

Details and patient eligibility

About

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.

Enrollment: 33 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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33 participants in 2 patient groups

Time-Controlled Adaptative Ventilation (TCAV)

Experimental group

Description:

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.

Treatment:

Other: Time-controlled adaptative ventilation (TCAV)

Volume Control Ventilation (VCV)

Active Comparator group

Description:

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.

Treatment:

Other: Volume-controlled ventilation (VCV)