Last updated: February 22, 2024
Sponsor: University Hospital, Tours
Overall Status: Active - Recruiting
Phase
N/A
Condition
Lung Injury
Respiratory Failure
Acute Respiratory Distress Syndrome (Ards)
Treatment
Standard of care
HFNO weaning protocol
Clinical Study ID
NCT06104956
DR230001
Ages 18-90 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
- Major patient admitted to the intensive care unit or continuous care unit for de novohypoxaemic acute respiratory failure (with a PaO2/FiO2 ratio <300 mmHg)
- Treated with HFNO with a flow rate ≥ 50L/min and inspired oxygen fraction (FiO2) ≥ 0.5, flow rate and FiO2 having to be stable (i.e. not increased) in the 24 hours priorto inclusion
- With a ROX index (SpO2/FiO2/Respiratory Rate) stable or improving in the 6 hours priorto inclusion and greater than 4.88
- Had a blood gas test under HFNO within 24 hours of inclusion
- Participant covered by or entitled to social security
- Informed consent signed by the patient or its relatives if the patient is incapable;this consent must then be confirmed by the patient as soon as possible
Exclusion
Exclusion Criteria:
- Presence of a patient included in the study and not weaned off HFNO in the sectormanaged by the nurse of the patient assessed for eligibility
- Concomitant non-invasive ventilation treatment
- Use of HFNO within 7 days of extubation
- Chronic obstructive pulmonary disease (Gold grade 3 or 4)
- Cardiogenic acute pulmonary oedema as the main cause of acute respiratory failure
- Diffuse interstitial lung disease as a medical history
- Patient with long-term non-invasive ventilation with external positive pressure
- Patient on long-term oxygen therapy at home
- Pregnant women, women in labour and breastfeeding mothers
- Persons deprived of their liberty by a judicial or administrative decision, personshospitalised without consent and persons admitted to a health or social establishmentfor purposes other than research.
- Minor
- Adult subject to a legal protection measure (guardianship, curators, person undercourt protection)
- Patient with a medical decision not to intubate
- Patients already included in the study, neither for the same stay if they were topresent the inclusion criteria again, nor for subsequent stays
Study Design
Total Participants: 370
Treatment Group(s): 2
Primary Treatment: Standard of care
Phase:
Study Start date:
February 17, 2024
Estimated Completion Date:
March 31, 2027
Connect with a study center
Intensive care, University Hospital, Blois
Blois,
FranceSite Not Available
Intensive care unit, University Hospital, Bourg-en-Bresse
Bourg-en-Bresse,
FranceSite Not Available
Intensive care, University Hospital, Bourges
Bourges,
FranceSite Not Available
Intensive care, University Hospital, Chartres
Chartres,
FranceSite Not Available
Intensive care, University Hospital, Cholet
Cholet,
FranceSite Not Available
Intensive care, University Hospital, Dax
Dax,
FranceSite Not Available
Intensive care, University Hospital, Le Mans,
Le Mans,
FranceSite Not Available
Intensive care, University Hospital, Orléans
Orléans,
FranceActive - Recruiting
Intensive care, University Hospital, Tours
Tours,
FranceSite Not Available
Intensive care unit, University Hospital, Vannes
Vannes,
FranceSite Not Available
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