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Conduct of Nasal High Flow Oxygen in Acute Respiratory Failure (DECIPHEROBS)

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ClinicalTrials.gov Identifier: NCT03311087
Recruitment Status : Unknown
Verified July 2018 by Prof Jean-Damien RICARD, Hôpital Louis Mourier.
Recruitment status was:  Recruiting
First Posted : October 16, 2017
Last Update Posted : July 20, 2018
Sponsor:
Information provided by (Responsible Party):
Prof Jean-Damien RICARD, Hôpital Louis Mourier

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.

Condition or disease
Acute Respiratory Failure With Hypoxia Hypoxemia

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.

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Study Type : Observational
Estimated Enrollment : 100 participants
Observational Model: Cohort
Time Perspective: Other
Official Title: Conduct of High Flow Nasal Cannula Oxygen During Acute Hypoxemic Respiratory Failure: a Multicentre Observational Study
Actual Study Start Date : July 9, 2018
Estimated Primary Completion Date : October 2018
Estimated Study Completion Date : November 2018





Primary Outcome Measures :
  1. values of gas flow over time (in liters per minute) [ Time Frame: entire duration of high flow therapy (5 to 7 days) ]
    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

  2. values of fraction in inspired oxygen (FiO2) over time (between 0.21 and 1.0) [ Time Frame: entire duration of high flow therapy (5 to 7 days) ]
    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


Secondary Outcome Measures :
  1. respiratory rate (breath per minute) [ Time Frame: entire duration of high flow therapy (5 to 7 days) ]
    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.

  2. pulse oximetry (SpO2) (percentage) [ Time Frame: entire duration of high flow therapy (5 to 7 days) ]
    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.

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



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   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
Criteria

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

- nasal high flow therapy administered for less than 24 hours


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03311087


Contacts
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Contact: Jean-Damien Ricard, MD, PhD +33147606195 jean-damien.ricard@aphp.fr
Contact: Jonathan Messika, MD, PhD +33147606195 jonathan.messika@aphp.fr

Locations
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France
Service de Réanimation Médico-Chirurgicale Recruiting
Colombes, France, 92700
Contact: Jean-Damien Ricard, MD, PhD       jean-damien.ricard@aphp.fr   
Contact: Guillaume Berquier, MD       gberquier@yahoo.fr   
Service de Réanimation Médicale Recruiting
Dijon, France
Contact: Jean-Pierre Quenot, MD       jean-pierre.quenot@chu-dijon.fr   
Service de Réanimation Médicale Recruiting
Grenoble, France
Contact: Nicolas Terzi, MD, PhD       nterzi@chu-grenoble.fr   
Service de Réanimation Recruiting
Longjumeau, France
Contact: Matthieu Le Meur, MD       m.lemeur@gh-nord-essonne.fr   
Service de Réanimation Recruiting
Orléans, France
Contact: Isabelle Runge, MD       Isabelle.runge@chr-orleans.fr   
Service de Réanimation Médicale et Resiratoire Recruiting
Paris, France
Contact: Elise Morawiec, MD       elisemorawiec@gmail.com   
Contact: maxens Decavèle, MD       maxencesar@hotmail.fr   
Service de Réanimation Médicale Recruiting
Paris, France
Contact: Ania nieszkowska, MD       ania.nieszkowska@aphp.fr   
Service de Réanimation Recruiting
Poitiers, France
Contact: Jean-Pierre Frat, MD       Jean-Pierre.FRAT@chu-poitiers.fr   
Service de Réanimation Médicale Recruiting
Rouen, France
Contact: Christophe Girault, MD       Christophe.Girault@chu-rouen.fr   
Service de Réanimation Médicale Recruiting
Tours, France
Contact: stephan Hermann, MD, PhD       stephanehrmann@gmail.com   
Sponsors and Collaborators
Hôpital Louis Mourier
Investigators
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Principal Investigator: Jean-Damien Ricard, MD, PhD Assistance Publique - Hôpitaux de Paris
Publications:

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Responsible Party: Prof Jean-Damien RICARD, Professor of Intensive Care Medicine, Hôpital Louis Mourier
ClinicalTrials.gov Identifier: NCT03311087    
Other Study ID Numbers: HLM_JDR6
First Posted: October 16, 2017    Key Record Dates
Last Update Posted: July 20, 2018
Last Verified: July 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Prof Jean-Damien RICARD, Hôpital Louis Mourier:
high flow nasal oxygen
acute hypoxemic respiratory failure
adults
intensive care unit
Additional relevant MeSH terms:
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Respiratory Insufficiency
Respiratory Distress Syndrome, Adult
Hypoxia
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Lung Diseases