Clinical trial NCT03311087: Conduct of Nasal High Flow Oxygen in Acute Respiratory Failure
Official title: Conduct of High Flow Nasal Cannula Oxygen During Acute Hypoxemic Respiratory Failure: a Multicentre Observational Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Acute Respiratory Failure With Hypoxia
Hypoxemia
Keywords: high flow nasal oxygen
acute hypoxemic respiratory failure
adults
intensive care unit
Lead sponsor: Hôpital Louis Mourier
Sponsor class: OTHER
First posted: 2017-10-16
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
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

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.

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.

Eligibility 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

Primary outcomes:
measure: values of gas flow over time (in liters per minute)
timeFrame: entire duration of high flow therapy (5 to 7 days)
measure: values of fraction in inspired oxygen (FiO2) over time (between 0.21 and 1.0)
timeFrame: entire duration of high flow therapy (5 to 7 days)
Secondary outcomes:
measure: respiratory rate (breath per minute)
timeFrame: entire duration of high flow therapy (5 to 7 days)
measure: pulse oximetry (SpO2) (percentage)
timeFrame: entire duration of high flow therapy (5 to 7 days)
measure: values of the Respiratory rate Oxygenation indeX ("ROX") index defined as the ratio of pulse oximetry over fraction of inspired oxygen to respiratory rate
timeFrame: 12 hours
Other outcomes:
Locations:
city: Colombes
country: France
facility: Service de Réanimation Médico-Chirurgicale
city: Dijon
country: France
facility: Service de Réanimation Médicale
city: Grenoble
country: France
facility: Service de Réanimation Médicale
city: Longjumeau
country: France
facility: Service de Réanimation
city: Orléans
country: France
facility: Service de Réanimation
city: Paris
country: France
facility: Service de Réanimation Médicale et Resiratoire
city: Paris
country: France
facility: Service de Réanimation Médicale
city: Poitiers
country: France
facility: Service de Réanimation
city: Rouen
country: France
facility: Service de Réanimation Médicale
city: Tours
country: France
facility: Service de Réanimation Médicale
Study officials:
affiliation: Assistance Publique - Hôpitaux de Paris
name: Jean-Damien Ricard, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.