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New treatment option for Acute Hypoxemic Respiratory Failure
Official title Weaning Protocol for High-flow Nasal Oxygen Therapy in Intensive Care
ClinicalTrials.gov ID: NCT06104956
What this study is testing
What is HFNO weaning protocol?
HFNO weaning protocol is an investigational medicine, being studied as a potential treatment for acute hypoxemic respiratory failure.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- High-flow nasal oxygen therapy (HFNO) is an oxygenation technique frequently used in intensive care. The main objective of our study is to show that the use of a protocol for weaning patients off high-flow nasal oxygen therapy (HFNO) in the intensive care unit increases the probability that patients will be weaned from HFNO at Day 7 post-randomisation.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 90
You may be able to join if
- Major patient admitted to the intensive care unit or continuous care unit for de novo hypoxaemic acute respiratory failure (with a PaO2/FiO2 ratio...
- Treated with HDNO for at least 24 hours in an intensive care unit or continuous care unit
- Treated with HFNO with a flow rate ≥ 50L/min and inspired oxygen fraction (FiO2) ≥ 0.5, at inclusion
- With a ROX index (SpO2/FiO2/Respiratory Rate) stable or improving in the 6 hours prior to inclusion and greater than 4.88 (the patient must not be in...
- Had a blood gas test under HFNO within 24 hours of inclusion
You likely can't join if
- Presence of a patient included in the study and not weaned off HFNO in the sector managed 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
See the full eligibility criteria
- Major patient admitted to the intensive care unit or continuous care unit for de novo hypoxaemic acute respiratory failure (with a PaO2/FiO2 ratio \<300 mmHg)
- Treated with HDNO for at least 24 hours in an intensive care unit or continuous care unit
- Treated with HFNO with a flow rate ≥ 50L/min and inspired oxygen fraction (FiO2) ≥ 0.5, at inclusion
- With a ROX index (SpO2/FiO2/Respiratory Rate) stable or improving in the 6 hours prior to inclusion and greater than 4.88 (the patient must not be in a worsening phase).
- 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
- Presence of a patient included in the study and not weaned off HFNO in the sector managed 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, persons hospitalised without consent and persons admitted to a health or social establishment for purposes other than research.
- Minor
- Adult subject to a legal protection measure (guardianship, curators, person under court protection)
- Patient with a medical decision not to intubate
- Patients already included in the study, neither for the same stay if they were to present the inclusion criteria again, nor for subsequent stays
The study team makes the final eligibility decision.
Where it's taking place
- Blois, France
- Bourg-en-Bresse, France
- Bourges, France
- Caen, France
- Chartres, France
- Cholet, France
- Dax, France
- Le Mans, France
- Orléans, France
- Tours, France
- Vannes, France
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 90 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Blois, France; Bourg-en-Bresse, France; Bourges, France; Caen, France; Chartres, France; Cholet, France and 5 more location(s). Enter your location above to see the nearest site and check your eligibility.
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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.