Personalized ventilatory strategy for patients with focal ARDS

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

This study tests a new way of adjusting breathing support for patients with focal ARDS to see if it helps them recover better than standard care.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 84 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Centre Hospitalier Universitaire Dijon (Academic / other)
• Drugs / interventions: Chemotherapy, radiation
• Locations: 1 site (Dijon)
• Trial ID: NCT04966624 on ClinicalTrials.gov

What this trial studies

This study investigates a ventilatory strategy tailored to the lung morphology of patients diagnosed with focal Acute Respiratory Distress Syndrome (ARDS). It aims to improve patient outcomes by adjusting mechanical ventilation based on ultrasound assessments of lung structure, as opposed to standard care. The study will include patients who have been on mechanical ventilation for less than 24 hours and have a recent diagnosis of focal ARDS. The approach is based on previous findings that suggest personalized ventilation may enhance survival rates compared to traditional methods.

Who should consider this trial

Good fit: Ideal candidates are adults over 18 who have been diagnosed with focal ARDS and are on mechanical ventilation for less than 24 hours.

Not a fit: Patients with chronic respiratory failure, severe acute asthma, or those who have undergone invasive mechanical ventilation for more than one week in the previous month may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to improved survival rates for patients with focal ARDS through personalized ventilatory management.

How similar studies have performed: While previous studies have explored ventilatory strategies in ARDS, this specific approach focusing on lung morphology via ultrasound is relatively novel and has not been extensively tested.

Eligibility criteria

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:

* 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.

Where this trial is running

Dijon

• Chu Dijon Bourgogne — Dijon, France (Recruiting)

Study contacts

• Study coordinator: BOUHEMAD Belaid

Conditions Focal Acute Respiratory Distress Syndrome