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Oxygen DeficiencyOHE-REANCT04141956

Incidence of Use of High-Flow Nasal Cannula Oxygen Therapy in Intensive Care Units Patients

An observational study of Oxygen Deficiency, run by Nantes University Hospital at 10 sites in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Patients with one or more organ failure (heart, lung) require hospitalization in intensive care where these failures can be managed. Nearly 30% of patients in intensive care units are hospitalized for acute respiratory distress (lung failure). Read more about this study

Who is it for?
Ages 18 to 99 years
Conditions the study is for
Oxygen Deficiency
What is being tested?
High-Flow Nasal Cannula
How many people
257 participants
Where
10 sitesFrance
Study dates
2 Nov 2019to 30 Oct 2020
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 99 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: All adults' patients, admitted to intensive care units treated with HFNC (indication is to discretion of doctor). For example : Acute Hypoxemic Respiratory Failure, Postoperative Respiratory Failure or systematic when weaning mechanical ventilation.

Who may be able to join

  • all adults' patients, admitted to intensive care units treated with HFNC (indication is to discretion of doctor).

Who cannot join

  • HFNC use for Preoxygenation and Apneic Oxygenation for Intubation
  • Minor patient, adult patient under guardianship, protected persons, pregnant woman, prior inclusion in the study.

Trial locations and contacts

10 sites in 1 country.

10 sites in 1 country

France10 sites
  • Chu Jean Minjoz Besancon

    Besançon, 25030

  • CHU CAEN

    Caen, 14033

  • Polyclinique Du Cotentin

    Cherbourg, 50100

  • Centre Hospitalier Du Mans

    Le Mans, 72037

  • CHU de Nantes

    Nantes

  • Chru Orleans

    Orléans, 45067

  • CH de SAINT NAZAIRE

    Saint-Nazaire, 44606

  • Hopital Foch

    Suresnes, 92150

  • Chru Bretonneau - Tours

    Tours, 37044

  • Centre Hospitalier Bretagne-Atlantique -Site de Vannes

    Vannes, 56017

Other trials in France

About this study

Official title: Incidence of Use of High-Flow Nasal Cannula Oxygen Therapy in Intensive Care Units : Prospective, Multi-center, Epidemiological, Uncontrolled Study

Patients with one or more organ failure (heart, lung) require hospitalization in intensive care where these failures can be managed. Nearly 30% of patients in intensive care units are hospitalized for acute respiratory distress (lung failure). This failure occurs in about 20% of postoperative patient, but it can also occur in the context of a pathology specific to the lung or after weaning of mechanical ventilation.

It is therefore interesting to develop several techniques to provide oxygen to these patients with the aim in particular to avoid the use of intubation (insertion of a tube into the trachea to achieve artificial ventilation). For the past ten years, High-Flow Nasal Canula (HFNC) has developed. This technique reduces the need for intubation but the studies are contradictory, however they agree on its ease of use and the few risks associated with it. The principle of this technique is to deliver a humidified and heated gas mixture at a high rate through large nasal cannula. The advantage of this device is its non-invasive and the possibility of administering a large amount of oxygen. There is a certain craze for this oxygenation technique despite few scientific studies in the literature. However, it requires the expertise of the medical and paramedical team so as not to delay intubation.

The investigators propose to carry out an observational study (without any modification of the usual practices) with epidemiological aim in order to make an inventory of the modes of use of the HFNC, in particular on its frequency of use and on its duration of use per patient hospitalized in intensive care. The investigators will recruit all HFNC patients in intensive care units (20 centers) (30 patients / center): 15 after weaning of mechanical ventilation and 15 others for other reasons. Patients will be followed every day and up to 48 hours after removal of the HFNC.

Read the detailed description

Oxygen therapy is one of the most prescribed treatments in medicine, especially in intensive care patients. It is an adjuvant therapy as a respiratory support whose goal is to maintain optimal ventilation and oxygenation and to improve alveolar gas exchange. HFNC is in full swing and increasingly used as an alternative to standard oxygen therapy in patients with acute respiratory failure (ARF). This nasal oxygenation technique, humidified and heated at high flow, initially developed in pediatrics is a simple and effective alternative for adults in IRA hospitalized in intensive care. The OHD makes it possible to deliver a gas mixture with a maximum flow rate of 70 l/min of oxygen via a generator connected to a chamber for humidifying and heating gases at 37 °. OHD offers several physiological benefits that could encourage its use: administration of a high oxygen-inspired fraction (FiO2), generation of a low level of flow-dependent PEP, reduction of nasopharyngeal resistance, and wash-rinse of the anatomic dead space, thanks to the high nasal flow. It is also a comfortable technique compared to the NIV.

This means of oxygen therapy is increasingly used in routine practice in our patients admitted to intensive care for non-hypercapnic respiratory insufficiency, especially since this reason for admission represents approximately 30% of our patients. HFNC is interesting because of the pathophysiological advantages mentioned above, especially in patients with ARI who are hypoxemic. These patients have a greater respiratory work with an increase in inspiratory flow of up to 30-40l/min on average and exceed 60l/min or 120l/min. This flow rate can not be compensated by conventional oxygen therapy, limited to 15 l / min, which is insufficient to guarantee a constant and high oxygen concentration during inspiration, hence the interest of OHD capable of delivering a maximum flow rate of 70 l/min.

Its use has grown exponentially since 2015, the year of publication of the multicenter study FLORALI, comparing different methods of oxygen therapy (OHD vs conventional oxygen therapy vs NIV / OHD) in 310 patients with acute non-hypercapnic respiratory failure (2). In this study, the primary endpoint is the rate of intubation. There was no significant difference (p = 0.17) between the 3 techniques used: OHD (37.7%), conventional oxygenation (46.8%) and VNI / OHD (50%), despite a clear decrease in mortality at J90 (p = 0.02) in the OHD group (12%) compared to the other 2 strategies but this is a secondary endpoint. However, in the most hypoxemic patients (P / F ≤ 200), post-hoc analysis found a significantly lower intubation rate (p = 0.009) in patients treated with OHD alone (35%) compared with conventional oxygen therapy group (53%) and NIV / OHD (58%), with the same observation regarding the number of days without mechanical ventilation. These authors also published a post-hoc analysis of this study. They analyzed the effect of OHD in 82 immunocompromised patients and concluded that OHD patients had a better prognosis compared to those treated with conventional oxygen therapy or NIV. They found a significantly lower intubation rate (p = 0.04) in the HFNC group (31%) compared to conventional oxygen therapy (43%) and NIV (65%). These results should be interpreted with caution since Lemiale et al., In a large multicenter randomized study, did not show a significant difference in morbidity-mortality intubation in 374 immunosuppressed IRA patients treated with NIV (HFNC alone or NIV / HFNC) or standard oxygen therapy. These results are interesting, although they are post-hoc analyzes and secondary judgment criteria. A multicenter French randomized study was published recently and confirms the results of the Lemiale team (HFNC is no better than standard oxygen therapy in immunocompromised patients). For these patients, another multicenter randomized controlled French trial is underway (NCT02978300).

Currently more and more patients, admitted for non-hypercapnic ARF, are treated with HFNC in first intention as well as post-extubation, because of its pathophysiological advantages, its comfort and its simplicity of setting up and use, despite the result of a single multicenter randomized study, positive only on secondary endpoints and post-hoc analyzes.

In addition, a recent meta-analysis, by Corley et al., Of randomized studies on the use of HFNC concluded in an insufficient level of evidence to recommend HFNC in ARF patients with a risk of delayed intubation of these patient. It should be noted, however, that the studies analyzed are heterogeneous in terms of patients, mode of administration of HFNC and etiology of ARF. Some authors are interested in parameters such as the ROX index to target patients at risk or not to progress to intubation in patients treated with HFNC which would secure its use and guide clinicians. Studies are underway to investigate the benefit of this device in patients with chronic respiratory failure admitted for hypercapnic ARF compared to standard oxygen between NIV sessions (NCT03406572). These authors also published a study concerning the use of HFNC in pre-oxygenation compared with BAVU and demonstrated a decrease in desaturation in pre-intubation. However, other authors have moderated these results in another randomized study with a different methodology, especially in terms of the use of OHD in apneic oxygenation (absence of mandibular sub-luxation). These results still show the heterogeneity of the practices as for its use in pre intubation.

Regarding its use in weaning mechanical ventilation, HFNC is increasingly used especially in post-operative without real benefit proven in the literature.

For example, in the University Hospital of Nantes in the Intensive Resuscitation Medicine (ICU) department, in 2017, 110 patients in ARF, were treated by HFNC out of 191 patients admitted for IRA, or 58% (institutional figures). There is a certain craze for this oxygenation technique in intensive care despite the low level of evidence, hence the interest of our epidemiological study.

It is a prospective, observational, multicentric (20 centers), epidemiological French study whose main objective is to evaluate the incidence of HFNC use. In order to calculate the incidence of use of the HFNC, The investigators will ask the different centers to provide us with the number of patients hospitalized in intensive care during the period of inclusion. the secondary objectives are: evaluation of morbidity and mortality in intensive care: intubation rate, weaning failure, weaning mode of HFNC. Epidemiological data: modalities of use, duration of use and indications.

Being tested
High-Flow Nasal Cannula
Medical subject headings
Hypoxia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • High-Flow Nasal CannulaOther

    Incidence of nasal High Flow Nasal Cannula (HFNC) Oxygen therapy in patients admitted to intensive care.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Incidence of nasal High-Flow Nasal Cannula (HFNC) Oxygen therapy in patients admitted to intensive care

    Incidence defined by: the ratio of the number of patients under HFNC on the number of patients admitted to intensive care during the period of inclusion.

    Measured: 28 days after enrollment

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Oct 2019
  2. Study start2 Nov 2019
  3. Primary completion30 Oct 2020
  4. Study completion30 Oct 2020

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case-control
Time perspective
Prospective
Enrolment
257 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04141956
Sponsor's protocol ID
RC19_0386
Acronym
OHE-REA
Status last verified
Mar 2025
First submitted
25 Oct 2019
Last updated
17 Mar 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Compagne P, Ehrmann S, Jonas M, Morin J, Cadiet J, Guitton C, Du Cheyron D, Devaquet J, Sauneuf B, Winiszewski H, Kamel T, Delbove A, Lakhal K, Reignier J, Le Thuaut A, Lascarrou JB. High-flow nasal-cannula oxygen therapy in intensive-care-unit patients: a prospective multicenter observational cohort study (OHE-REA). Sci Rep. 2026 Feb 24;16(1):10379. doi: 10.1038/s41598-026-39969-4.

    PubMed 41735369

Questions about this trial

What is this clinical trial studying?

An observational study of Oxygen Deficiency, run by Nantes University Hospital at 10 sites in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 17 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 10 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Incidence of nasal High-Flow Nasal Cannula (HFNC) Oxygen therapy in patients admitted to intensive care (time frame: 28 days after enrollment). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04141956, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Mar 2025.

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