NCT03311087

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jul 2018

Shorter than P25 for all trials

Geographic Reach
1 country

10 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 11, 2017

Completed
5 days until next milestone

First Posted

Study publicly available on registry

October 16, 2017

Completed
9 months until next milestone

Study Start

First participant enrolled

July 9, 2018

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2018

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2018

Completed
Last Updated

July 20, 2018

Status Verified

July 1, 2018

Enrollment Period

3 months

First QC Date

October 11, 2017

Last Update Submit

July 18, 2018

Conditions

Acute Respiratory Failure With HypoxiaHypoxemia

Keywords

high flow nasal oxygenacute hypoxemic respiratory failureadultsintensive care unit

Outcome Measures

Primary Outcomes (2)

  • 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

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

  • 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

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

Secondary Outcomes (3)

  • respiratory rate (breath per minute)

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

  • pulse oximetry (SpO2) (percentage)

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

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

    12 hours

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability 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

You may qualify if:

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

You may not qualify if:

  • \- nasal high flow therapy administered for less than 24 hours

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (10)

Service de Réanimation Médico-Chirurgicale

Colombes, 92700, France

RECRUITING

Service de Réanimation Médicale

Dijon, France

RECRUITING

Service de Réanimation Médicale

Grenoble, France

RECRUITING

Service de Réanimation

Longjumeau, France

RECRUITING

Service de Réanimation

Orléans, France

RECRUITING

Service de Réanimation Médicale et Resiratoire

Paris, France

RECRUITING

Service de Réanimation Médicale

Paris, France

RECRUITING

Service de Réanimation

Poitiers, France

RECRUITING

Service de Réanimation Médicale

Rouen, France

RECRUITING

Service de Réanimation Médicale

Tours, France

RECRUITING

Related Publications (5)

  • 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.

    PMID: 25981908BACKGROUND

  • 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.

    PMID: 21946925BACKGROUND

  • 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.

    PMID: 21958974BACKGROUND

  • 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.

    PMID: 25371400BACKGROUND

  • 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.

    PMID: 27481760BACKGROUND

MeSH Terms

Conditions

HypoxiaRespiratory Insufficiency

Condition Hierarchy (Ancestors)

Signs and Symptoms, RespiratorySigns and SymptomsPathological Conditions, Signs and SymptomsRespiration DisordersRespiratory Tract Diseases

Study Officials

  • Jean-Damien Ricard, MD, PhD

    Assistance Publique - Hôpitaux de Paris

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Jean-Damien Ricard, MD, PhD

CONTACT

+33147606195jean-damien.ricard@aphp.fr

Jonathan Messika, MD, PhD

CONTACT

+33147606195jonathan.messika@aphp.fr

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
OTHER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Intensive Care Medicine

Study Record Dates

First Submitted

October 11, 2017

First Posted

October 16, 2017

Study Start

July 9, 2018

Primary Completion

October 1, 2018

Study Completion

November 1, 2018

Last Updated

July 20, 2018

Record last verified: 2018-07

Locations

FR(10)