ClinicalTrials.gg
Status unknownNCT03311087DECIPHEROBSUpdated Jul 20, 2018

Conduct of Nasal High Flow Oxygen in Acute Respiratory Failure

An observational study in Acute Respiratory Failure With Hypoxia and Hypoxemia, sponsored by Hôpital Louis Mourier. Status unknown at 10 sites in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2018-07-20.

Sponsored by Hôpital Louis Mourier · Observational

The sponsor has not verified this record recently (last verified Jul 2018), so the status shown — last known as Recruiting — may be out of date.

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Study type
Observational
Model
Cohort
Time perspective
Other
Enrollment
100
Ages
18 Years and older
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-14

Among 71 studies in Hypoxia with a site in France — 17 open to participants now, 17 under way, 1 of them phase 3. Hypoxia · France.

Planned enrollment
12th of 21
100 · median 101
Started
2018
with 2 others
Observational
21 of 71
2 open now
Registered
33rd of 71
by date
Lead sponsor
2 of 71
Hôpital Louis Mourier

Among the 71 studies in Hypoxia with a site in France, this one is the 12th largest by planned enrollment of the 21 observational ones that give a count, is one of 3 that started in 2018, is one of 21 observational ones, and was the 33rd registered.

Hypoxia

1,078 studies on the registry are indexed under Hypoxia; 214 are open to participants now.

Browse Hypoxia studies →

Open to participants now

17 of the 71 studies in Hypoxia with a site in France are open now. Recruiting first, the newest first:

12 more — sign in →

All 17 open studies →

A study can be open while its sites in France have not opened yet or have stopped. Only those recruiting at a site in France →

Who these studies take

Of the 126 Hypoxia studies recruiting now, 53 (42%) set no upper age limit and 46 (37%) stop at 75 or younger; 15 take children under 18; 35 take healthy volunteers.

This study: 18 Years and older · all sexes · no healthy volunteers.

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02

Study summary

Although many studies have investigated the clinical benefits of nasal high flow during acute hypoxemic respiratory failure, there is no data (and even less so recommendations) on how to best conduct this technique, including its initiation and its weaning periods. Investigators will assess in a multicenter, observational study, the way clinicians use nasal high flow therapy in patients with acute respiratory failure in order to try identify one or more strategies that may be then compared in an interventional study.

Read the detailed description

Nasal high flow oxygen therapy is increasingly used as a first-line treatment for hypoxemic acute respiratory failure, because of its remarkable tolerance (in comparison with NIV) and its physiological effects (nasopharyngeal dead space washout, positive end-expiratory pressure effect with possible alveolar recruitment, better matching with the patient's inspiratory flow, more reliable and adjustable FiO2); that together contribute to a reduction in respiratory workload and better oxygenation.

Although many studies have investigated the clinical benefits of nasal high flow during acute hypoxemic respiratory failure, there are no data (and even less recommendations) on how to best conduct this technique, including its initiation and its weaning periods.

Because different approaches exist among clinicians, investigators believe that a multicenter observational study that would collect data regarding the different ways high flow is conducted in patients with acute respiratory failure is necessary before performing an interventional study that would test and compare different strategies in order to answer the question: what are the best strategies (in terms of flow and FiO2 settings) to initiate and to wean high-flow oxygen therapy in patients with acute respiratory failure?

Investigators will assess in a multicenter, observational study, the way clinicians use nasal high flow therapy in patients with acute respiratory failure in order to try identify one or more strategies that may be then compared in an interventional study.

03

Conditions studied

  • Acute Respiratory Failure With Hypoxia
  • Hypoxemia

Keywords

  • high flow nasal oxygen
  • acute hypoxemic respiratory failure
  • adults
  • intensive care unit
04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

Adult patients admitted to an ICU or an intermediate care unit, who require nasal high flow oxygen therapy for acute hypoxemic respiratory failure

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Patients aged 18 or older
  • admitted to the intensive care unit (ICU) or to the intermediate care for acute hypoxemic respiratory failure (whatever the cause)
  • treated with nasal high flow oxygen therapy
  • with a minimal FiO2 of FiO2≥50% and a gas flow ≥40 L/min
  • anticipated duration of nasal high flow therapy greater or equal to 24 hours

Non-inclusion Criteria:

  • prophylactic, post-extubation nasal high flow therapy
  • palliative nasal high flow therapy (do-not-resuscitate order)

Exclusion criteria

Exclusion criteria

  • nasal high flow therapy administered for less than 24 hours
05

Study design

Observational model
Cohort
Time perspective
Other
Enrollment
100 participants (estimated)
Patient registry
No
06

What researchers measure

Primary outcomes

  1. values of gas flow over time (in liters per minute)

    values of gas flow set on the device of nasal high flow will be monitored over time so as to describe how physicians set and modify this parameter during treatment with nasal high flow

    Time frame: entire duration of high flow therapy (5 to 7 days)

  2. values of fraction in inspired oxygen (FiO2) over time (between 0.21 and 1.0)

    values of FiO2 set on the device of nasal high flow will be monitored over time so as to describe how physicians set and modify this parameter during treatment with nasal high flow

    Time frame: entire duration of high flow therapy (5 to 7 days)

Secondary outcomes

  1. respiratory rate (breath per minute)

    values of respiratory rate upon initiation of nasal high flow and at each change of nasal high flow parameters (gas flow or FiO2) will be monitored.

    Time frame: entire duration of high flow therapy (5 to 7 days)

  2. pulse oximetry (SpO2) (percentage)

    values of oxgen saturation upon initiation of nasal high flow and at each change of nasal high flow parameters (gas flow or FiO2) will be monitored.

    Time frame: entire duration of high flow therapy (5 to 7 days)

  3. values of the Respiratory rate Oxygenation indeX ("ROX") index defined as the ratio of pulse oximetry over fraction of inspired oxygen to respiratory rate

    values of the "ROX" index will be monitored at different time points (2, 6 and 12 hours after nasal high flow therapy initiation)

    Time frame: 12 hours

07

Study locations

10 of 10 sites recruiting
08

References and documents

Publications

  • Frat JP, Thille AW, Mercat A, Girault C, Ragot S, Perbet S, Prat G, Boulain T, Morawiec E, Cottereau A, Devaquet J, Nseir S, Razazi K, Mira JP, Argaud L, Chakarian JC, Ricard JD, Wittebole X, Chevalier S, Herbland A, Fartoukh M, Constantin JM, Tonnelier JM, Pierrot M, Mathonnet A, Beduneau G, Deletage-Metreau C, Richard JC, Brochard L, Robert R; FLORALI Study Group; REVA Network. High-flow oxygen through nasal cannula in acute hypoxemic respiratory failure. N Engl J Med. 2015 Jun 4;372(23):2185-96. doi: 10.1056/NEJMoa1503326. Epub 2015 May 17. PubMed 25981908 ↗
  • Sztrymf B, Messika J, Bertrand F, Hurel D, Leon R, Dreyfuss D, Ricard JD. Beneficial effects of humidified high flow nasal oxygen in critical care patients: a prospective pilot study. Intensive Care Med. 2011 Nov;37(11):1780-6. doi: 10.1007/s00134-011-2354-6. Epub 2011 Sep 27. PubMed 21946925 ↗
  • Sztrymf B, Messika J, Mayot T, Lenglet H, Dreyfuss D, Ricard JD. Impact of high-flow nasal cannula oxygen therapy on intensive care unit patients with acute respiratory failure: a prospective observational study. J Crit Care. 2012 Jun;27(3):324.e9-13. doi: 10.1016/j.jcrc.2011.07.075. Epub 2011 Sep 29. PubMed 21958974 ↗
  • Messika J, Ben Ahmed K, Gaudry S, Miguel-Montanes R, Rafat C, Sztrymf B, Dreyfuss D, Ricard JD. Use of High-Flow Nasal Cannula Oxygen Therapy in Subjects With ARDS: A 1-Year Observational Study. Respir Care. 2015 Feb;60(2):162-9. doi: 10.4187/respcare.03423. Epub 2014 Nov 4. PubMed 25371400 ↗
  • Roca O, Messika J, Caralt B, Garcia-de-Acilu M, Sztrymf B, Ricard JD, Masclans JR. Predicting success of high-flow nasal cannula in pneumonia patients with hypoxemic respiratory failure: The utility of the ROX index. J Crit Care. 2016 Oct;35:200-5. doi: 10.1016/j.jcrc.2016.05.022. Epub 2016 May 31. PubMed 27481760 ↗

Individual participant data

Plan to share: Undecided

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Jul 2018 (actual). Primary completion is estimated for Oct 2018, 3 months after the start.

Of 125 non-industry observational studies under Hypoxia, half reached primary completion within 19 months of starting (the median), counting those still running; a quarter within 7 and three quarters within 74. This study's planned 3 months is below that.

Counting every sponsor, half of 155 studies reached it within 14 months; a quarter within 3 and three quarters within 46.

How these figures are worked out, and which studies are left out of them.

Registered
Oct 11, 2017
First posted
Oct 16, 2017
StartActual
Jul 9, 2018
Primary completionEst.
Oct 2018
CompletionEst.
Nov 2018
Last update
Jul 20, 2018
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jul 20, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03311087
Lead sponsor
Hôpital Louis Mourier
Responsible party
Prof Jean-Damien RICARD (Professor of Intensive Care Medicine, Hôpital Louis Mourier) — Principal investigator
First posted
Oct 16, 2017
Start date
Jul 9, 2018
Primary completion
Oct 2018 (estimated)
Completion
Nov 2018 (estimated)
Last update
Jul 20, 2018

Study contacts

Jean-Damien Ricard, MD, PhD
Contact
jean-damien.ricard@aphp.fr
+33147606195
Jonathan Messika, MD, PhD
Contact
jonathan.messika@aphp.fr
+33147606195
Jean-Damien Ricard, MD, PhD
principal investigator · Assistance Publique - Hôpitaux de Paris

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Jul 2018. You cannot join it, but the record below documents what was studied.

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