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RecruitingNCT04966624LUVSUpdated Nov 25, 2025

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

An interventional study of LUVS" ventilatory strategy composed of a bundle of measures and Ventilatory management according to international recommendations (Société de Réanimation de la Langue Française) in Focal Acute Respiratory Distress Syndrome, sponsored by Centre Hospitalier Universitaire Dijon. Recruiting at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-11-25.

Sponsored by Centre Hospitalier Universitaire Dijon · Not applicable, Interventional, and Other

From the registry’s dates

  • Started Oct 2021; still recruiting 4 years 11 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
84
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

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

02

Conditions studied

  • Focal Acute Respiratory Distress Syndrome
03

In context

Lead sponsor

Centre Hospitalier Universitaire Dijon is the lead sponsor of 495 studies on the registry; 105 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • 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. ARDS according to the Berlin classification: i.e. arterial oxygen pressure to inspired oxygen fraction ratio less than or equal to 300, with a PEEP greater than or equal to 5, presence of bilateral radiological infiltrates not fully explained by heart failure or volume overload
  • Focal ARDS determined on pulmonary ultrasound

Exclusion criteria

Exclusion Criteria:

  • person who is not a beneficiary of national health insurance
  • person who is subject to a legal measure of protection (curatorship, guardianship)
  • pregnant or breastfeeding women
  • minor
  • Patient having benefited from an invasive mechanical ventilation of more than one week in the previous month;
  • ARDS in the previous month;
  • Chronic respiratory failure under NIV or long term oxygen;
  • Severe acute asthma;
  • Lobectomy;
  • Pneumothorax;
  • Pneumomediastinum;
  • Pulmonary fibrosis;
  • Morbid obesity with a BMI above 40 ;
  • Cancer with metastasis;
  • Bone marrow transplantation;
  • Chemotherapy-induced neutropenia;
  • Cirrhosis with a Child-Pugh score of C;
  • Suspected or confirmed intracranial hypertension;
  • Concurrent participation in another ARDS study;
  • Extensive burns on the torso.
05

Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
84 participants (estimated)

Study arms

  • Experimental
    interventional

    Procedure: LUVS" ventilatory strategy composed of a bundle of measures

  • Active comparator
    control

    Procedure: Ventilatory management according to international recommendations (Société de Réanimation de la Langue Française)

Interventions

  • ProcedureLUVS" ventilatory strategy composed of a bundle of measures

    Ventilation in APRV mode early prone sessions, adjustment of positive expiratory pressure according to the patient's BMI and no curarization

  • ProcedureVentilatory management according to international recommendations (Société de Réanimation de la Langue Française)

    Ventilatory management according to international recommendations (Société de Réanimation de la Langue Française)

06

What researchers measure

Primary outcomes

  1. Number of days without invasive ventilation

    Time frame: 28 days

07

Study locations

1 of 1 sites recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 25, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT04966624
Lead sponsor
Centre Hospitalier Universitaire Dijon
Responsible party
Sponsor
First posted
Jul 19, 2021
Start date
Oct 13, 2021
Primary completion
Jul 2028 (estimated)
Completion
Jul 2028 (estimated)
Last update
Nov 25, 2025

Study contacts

BOUHEMAD Belaid
Contact
belaid.bouhemad@chu-dijon.fr
03 80 29 30 79

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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