Conduct of Nasal High Flow Oxygen in Acute Respiratory Failure

NCT ID: NCT03311087

Last Updated: 2018-07-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-07-09

Study Completion Date

2018-11-30

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Acute Respiratory Failure With Hypoxia Hypoxemia

Study Design

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Observational Model Type

COHORT

Study Time Perspective

OTHER

Eligibility Criteria

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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


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

Exclusion Criteria

\- nasal high flow therapy administered for less than 24 hours
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hôpital Louis Mourier

OTHER

Sponsor Role lead

Responsible Party

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Prof Jean-Damien RICARD

Professor of Intensive Care Medicine

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Jean-Damien Ricard, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Assistance Publique - Hôpitaux de Paris

Locations

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Service de Réanimation Médico-Chirurgicale

Colombes, , France

Site Status RECRUITING

Service de Réanimation Médicale

Dijon, , France

Site Status RECRUITING

Service de Réanimation Médicale

Grenoble, , France

Site Status RECRUITING

Service de Réanimation

Longjumeau, , France

Site Status RECRUITING

Service de Réanimation

Orléans, , France

Site Status RECRUITING

Service de Réanimation Médicale et Resiratoire

Paris, , France

Site Status RECRUITING

Service de Réanimation Médicale

Paris, , France

Site Status RECRUITING

Service de Réanimation

Poitiers, , France

Site Status RECRUITING

Service de Réanimation Médicale

Rouen, , France

Site Status RECRUITING

Service de Réanimation Médicale

Tours, , France

Site Status RECRUITING

Countries

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France

Central Contacts

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Jean-Damien Ricard, MD, PhD

Role: CONTACT

+33147606195

Jonathan Messika, MD, PhD

Role: CONTACT

+33147606195

Facility Contacts

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Jean-Damien Ricard, MD, PhD

Role: primary

Guillaume Berquier, MD

Role: backup

Jean-Pierre Quenot, MD

Role: primary

Nicolas Terzi, MD, PhD

Role: primary

Matthieu Le Meur, MD

Role: primary

Isabelle Runge, MD

Role: primary

Elise Morawiec, MD

Role: primary

maxens Decavèle, MD

Role: backup

Ania nieszkowska, MD

Role: primary

Jean-Pierre Frat, MD

Role: primary

Christophe Girault, MD

Role: primary

stephan Hermann, MD, PhD

Role: primary

References

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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.

Reference Type BACKGROUND
PMID: 25981908 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 21946925 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 21958974 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 25371400 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 27481760 (View on PubMed)

Other Identifiers

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HLM_JDR6

Identifier Type: -

Identifier Source: org_study_id

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