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

ARDS Clinical Trial

— TCAV-CT  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05874973
• Other study ID #: 2021PI212
• Status: Recruiting
• Phase: N/A
• Start date: October 25, 2023
• Est. completion date: December 30, 2024

Study information

• Verified date: February 2024
• Source: Central Hospital, Nancy, France
• Contact: Benjamin Pequignot, MD
• Phone: +33383153851
• Email: b.pequignot[@]chru-nancy.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 33
• Est. completion date: December 30, 2024
• Est. primary completion date: June 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• ARDS

Intervention

Other:
• Time-controlled adaptative ventilation (TCAV)
Ventilation with TCAV set on the APRV mode on the ventilator.
• Volume-controlled ventilation (VCV)
Ventilation with the VCV mode set on the ventilator.

Locations

Country	Name	City	State
France	CHRU	Nancy

Sponsors (1)

Lead Sponsor	Collaborator
Central Hospital, Nancy, France

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	Correlation between transpulmonary driving pressure and tidal hyperinflation in TCAV	Area under ROC curve of transpulmonary driving pressure to detect cyclic hyperinflation	10 minutes
Secondary	Correlation between driving pressure and tidal hyperinflation in TCAV	Area under ROC curve of driving pressure to detect cyclic hyperinflation	10 minutes