Quantitative Computed Tomography for Mortality Risk Stratification in ARDS

Acute Respiratory Distress Syndrome Clinical Trial

— CT4ARDS-2  

Official title:

Quantitative Computed Tomography for Mortality Risk Stratification in ARDS

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06113276
• Other study ID #: 69HCL21_0664
• Secondary ID: 194_v3
• Status: Recruiting
• Start date: November 6, 2020
• Est. completion date: May 1, 2025

Study information

• Verified date: January 2024
• Source: Hospices Civils de Lyon
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Acute respiratory distress syndrome remains a deadly disease with hospital mortality remaining between 40 to 50%. ARDS mortality risk factors have been identified from patient history, common clinical and biological variables in the lung SAFE study. Part of ARDS mortality is attributable to ventilator-induced lung injury (VILI), in relation with inappropriate settings on the ventilator. Tidal hyperinflation and recruitment/derecruitment during lung inflation are 2 identified mechanisms leading to VILI, that may be identified on computed tomography while poorly identified with variables collected at the bedside.

The aim of this study is to identify whether tidal hyperinflation identified on computed tomography is a risk factor for ARDS mortality, independently from know bio-clinical risk factors.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 210
• Est. completion date: May 1, 2025
• Est. primary completion date: November 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 15 Years and older

Eligibility

Inclusion Criteria:

• Patient aged 15 or older with ARDS according to the Berlin definition

• invasive mechanical ventilation with PaO2/FiO2 = 300 mm Hg

• with computed tomography acquired at both end-expiration and end-inspiration, or at both PEEP 5 and 15 cm H2O at end-expiration

• PEEP setting according to a PEEP/FiO2 table, with secondary adjustment according to hemodynamic tolerance

• Tidal volume 6 ml/kg of predicted body weight or less

Exclusion Criteria:

• Use of contrast agent during computed tomography acquisition

• ARDS criteria onset since more than 72 hours or ECMO onset since more than 72 hours

• Proven COPD

• Pneumothorax or bronchopleural fistula

• Patient with spontaneous breathing preventing realization of end-expiratory and end-inspiratory pauses

• Previous inclusion in current study

• Patient under a legal protective measure

Related Conditions & MeSH terms

• Acute Lung Injury
• Acute Respiratory Distress Syndrome
• Respiratory Distress Syndrome
• Respiratory Distress Syndrome, Newborn

Intervention

Radiation:
• Low dose computed tomography to evaluate biomechanical parameters in the lung
In the participating to the study, response to PEEP increase and tidal inflation are evaluated with a software computing biomechanical parameters (tidal hyperinflation and lung recruitability). Tidal hyperinflation and recruitment are computed on CT images acquired within 72 hours after ARDS onset or with 72h after ECMO onset.

Locations

Country	Name	City	State
France	Service de Médecine Intensive Réanimation Hôpital Michallon - CHU Grenoble Alpes	La Tronche
France	Hospices Civils de Lyon - Hôpital de la Croix Rousse - Service de Médecine Intensive Réanimation	Lyon
France	Service de Réanimation Polyvalente Centre Hospitalier Lyon Sud Hospices Civils de Lyon	Pierre-Bénite
France	Centre Hospitalier Universitaire de Rennes	Rennes

Sponsors (1)

Lead Sponsor	Collaborator
Hospices Civils de Lyon

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Odd ratio of tidal hyperinflation assessed on CT at day-0 as an independent predictor of 90-day mortality	Tidal hyperinflation is computed as the volume difference of hyperinflated lung (i.e., with CT attenuation between -1000 and -900 Hounsfield units) between and-expiration and end-inspiration at the PEEP level chosen by clinician	Day-0 (time of realization of CT scan)