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Weaning Protocol for High-flow Nasal Oxygen Therapy in Intensive Care

ConditionsAcute Hypoxemic Respiratory FailureHigh-flow Nasal Oxygen Therapy
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-90
SponsorUniversity Hospital, Tours

About this trial

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.

This is a open-label multicentre randomised controlled trial conducted in two parallel groups.

The primary endpoint is the success rate at Day 7, with success defined as "definitive" weaning from HFNO, i.e. patients weaned from HFNO for more than 48 hours without recourse to non-invasive ventilation (NIV) or intubation and still alive at Day 7.

The weaning protocol will be started as soon as the patient meets all the inclusion criteria, considered to be the prerequisites for initiating weaning from HFNO. Patients will be monitored until Day 28 maximum.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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).

Disqualifiers

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)

Trial design

Design model

Parallel

Treatments tested in this trial

  • HFNO weaning protocol

    Drug

    Algorithm based on SpO2 values and respiratory rate: a decrease of FiO2 and of the flow will be done

  • HFNO Standard of care

    Drug

    Weaning methods will be left to the free choice of the practitioner.

Treatment groups

370 Participants
are divided into 2 treatment groups
Group A: Experimental group : Imposed weaning protocolExperimental treatment 1 intervention
Group B: Control groupActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

The success rate at Day 7

Success being defined as "definitive" weaning from HFNO, i.e. a patient weaned for more than 48 hours from HFNO without recourse to non-invasive ventilation or intubation and still alive at Day 7.

Time frame
At day 7

Secondary outcomes

1

High-flow nasal oxygen therapy (HFNO) weaning rate at day 28

Time frame
At day 28
2

Time to definitive weaning from HFNO

Time frame
From randomisation to day 28
3

Cumulative incidence of intubation

Time frame
From randomisation to day 28
4

Cumulative incidence of use of curative non-invasive ventilation

Time frame
From randomisation to day 28

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University Hospital, Tours

Lead sponsor

Source ClinicalTrials.gov
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