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

NCT ID: NCT05874973

Last Updated: 2024-02-07

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 33 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-10-25
• Study Completion Date: 2024-12-30

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.

Conditions

ARDS

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Time-controlled adaptative ventilation (TCAV)

Intervention Type: OTHER

Ventilation with TCAV set on the APRV mode on the ventilator.

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.

Group Type: ACTIVE_COMPARATOR

Volume-controlled ventilation (VCV)

Intervention Type: OTHER

Ventilation with the VCV mode set on the ventilator.

Interventions

Time-controlled adaptative ventilation (TCAV)

Ventilation with TCAV set on the APRV mode on the ventilator.

Intervention Type: OTHER

Volume-controlled ventilation (VCV)

Ventilation with the VCV mode set on the ventilator.

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Central Hospital, Nancy, France

OTHER

Sponsor Role: lead

Responsible Party

PEQUIGNOT Benjamin

Dr

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Benjamin Pequignot

Role: PRINCIPAL_INVESTIGATOR

CHRU Nancy

Locations

CHRU

Nancy, , France

Site Status: RECRUITING

Countries

France

Central Contacts

Benjamin Pequignot, MD

Role: CONTACT

b.pequignot@chru-nancy.fr

+33383153851

Matthieu Koszutski, MD

Role: CONTACT

m.koszutski@chru-nancy.fr

+3383153017

Facility Contacts

Benjamin Pequignot, MD

Role: primary

b.pequignot@chru-nancy.fr

+33383153851

Other Identifiers

2021PI212

Identifier Type: -

Identifier Source: org_study_id