Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
NCT04966624

Ventilatory Strategy Based on Ultrasound Lung Morphology in Patients With Focal ARDS

Led by Centre Hospitalier Universitaire Dijon · Updated on 2025-11-25

84

Participants Needed

1

Research Sites

350 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

ARDS is characterized by a diffuse, bilateral, extensive alveolar-interstitial infiltrate related to damage to the alveolar membrane. Studies of lung morphology assessed by CT scan have shown 2 types of ARDS. When the loss of ventilation is posterior and caudal, and the pulmonary parenchyma is otherwise "healthy", ARDS is said to be focal. When the loss of ventilation is diffuse, associated with excess tissue affecting the entire lung parenchyma, ARDS is said to be non-focal or diffuse. Only one recent multicenter study has evaluated whether individualized PEEP adjustment according to lung morphology (focal vs. non-focal) could improve ARDS survival outcomes compared with standard of care. Results for the primary endpoint, 90-day mortality, were negative. But lung morphology was misclassified on CT occurred 85 (21%) of 400 patients. In addition, per-protocol analysis in which misclassified patients were excluded showed that mortality was significantly lower in the personalized ventilation group than in the control group. Lung ultrasound may be the ideal bedside imaging technique. The loss of pulmonary aeration and its variations induced by therapeutic maneuvers can be quantified by lung ultrasound. Lung ultrasound is a non-invasive, non-ionizing radiation method that can be easily used at the bedside. APRV ventilation coupled with spontaneous breathing activity prevents atelectasis formation, recruits less ventilated areas, prevents mechanical ventilation-induced lung injury and improves lung compliance. The hypothesis is that a "LUVS" ventilatory strategy composed of a bundle of measures all aiming at reopening the atelectatic pulmonary zones in focal ARDS (synergistic effect of spontaneous ventilation in APRV mode, early prone sessions, and adjustment of PEEP according to the patient's BMI), could decrease the number of days under mechanical ventilation, compared to protective ventilation with low tidal volume according to the current international recommendations

CONDITIONS

Official Title

Ventilatory Strategy Based on Ultrasound Lung Morphology in Patients With Focal ARDS

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Person who has given oral consent or has been included in an emergency
  • Older than 18 years
  • On mechanical ventilation for less than 24 hours
  • Diagnosis of ARDS for less than 24 hours according to Berlin classification (PaO2/FiO2 ≤ 300, PEEP ≥ 5, bilateral infiltrates not due to heart failure or volume overload)
  • Focal ARDS determined on pulmonary ultrasound
Not Eligible

You will not qualify if you...

  • Not a beneficiary of national health insurance
  • Subject to legal protection measures (curatorship, guardianship)
  • Pregnant or breastfeeding women
  • Minor
  • Invasive mechanical ventilation for more than one week in previous month
  • ARDS in previous month
  • Chronic respiratory failure under non-invasive ventilation or long-term oxygen
  • Severe acute asthma
  • Lobectomy
  • Pneumothorax
  • Pneumomediastinum
  • Pulmonary fibrosis
  • Morbid obesity with BMI above 40
  • Cancer with metastasis
  • Bone marrow transplantation
  • Chemotherapy-induced neutropenia
  • Cirrhosis with Child-Pugh score C
  • Suspected or confirmed intracranial hypertension
  • Participation in another ARDS study
  • Extensive burns on the torso

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

1
2
3
+1

Trial Site Locations

Total: 1 location

1

Chu Dijon Bourgogne

Dijon, France, 21000

Actively Recruiting

Loading map...

Research Team

B

BOUHEMAD Belaid

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

OTHER

Number of Arms

2

Not the Right Trial for You?

Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.

Already have an account? Log in here