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

NCT05874973 | Recruiting

• 1 other identifier: 2021PI212
• Study Type: interventional
• Target: 33
• Locations: 1 country
• Sites: 1

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

Keywords

Mechanical Ventilation

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• End-inspiratory overdistention in TCAV

  10 minutes

• Tidal hyperinflation in TCAV

  10 minutes

• Atelectrauma in TCAV and VCV

  10 minutes

• Correlation between transpulmonary driving pressure and tidal hyperinflation in TCAV

  10 minutes

• Correlation between driving pressure and tidal hyperinflation in TCAV

  10 minutes

Study Arms (2)

Time-Controlled Adaptative Ventilation (TCAV)

EXPERIMENTAL

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)

Volume Control Ventilation (VCV)

ACTIVE COMPARATOR

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)

Interventions

Time-controlled adaptative ventilation (TCAV) OTHER

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

Time-Controlled Adaptative Ventilation (TCAV)

Volume-controlled ventilation (VCV) OTHER

Ventilation with the VCV mode set on the ventilator.

Volume Control Ventilation (VCV)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Central Hospital, Nancy, France: lead

Study Sites (1)

CHRU

Nancy, France

RECRUITING

Study Officials

• Benjamin Pequignot

  CHRU Nancy

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Benjamin Pequignot, MD

CONTACT

+33383153851; b.pequignot@chru-nancy.fr

Matthieu Koszutski, MD

CONTACT

+3383153017; m.koszutski@chru-nancy.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr

Study Record Dates

• First Submitted: May 16, 2023
• First Posted: May 25, 2023
• Study Start: October 25, 2023
• Primary Completion: June 30, 2024
• Study Completion: December 30, 2024
• Last Updated: February 7, 2024

Record last verified: 2024-02

Locations

FR (1)