Conduct of Nasal High Flow Oxygen in Acute Respiratory Failure

Hypoxemia Clinical Trial

— DECIPHEROBS  

Official title:

Conduct of High Flow Nasal Cannula Oxygen During Acute Hypoxemic Respiratory Failure: a Multicentre Observational Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03311087
• Other study ID #: HLM_JDR6
• Status: Recruiting
• Start date: July 9, 2018
• Est. completion date: November 2018

Study information

• Verified date: July 2018
• Source: Hôpital Louis Mourier
• Contact: Jean-Damien Ricard, MD, PhD
• Phone: +33147606195
• Email: jean-damien.ricard[@]aphp.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: November 2018
• Est. primary completion date: October 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Acute Respiratory Failure With Hypoxia
• Hypoxemia
• Hypoxia
• Respiratory Distress Syndrome, Adult
• Respiratory Insufficiency

Locations

Country	Name	City	State
France	Service de Réanimation Médico-Chirurgicale	Colombes
France	Service de Réanimation Médicale	Dijon
France	Service de Réanimation Médicale	Grenoble
France	Service de Réanimation	Longjumeau
France	Service de Réanimation	Orléans
France	Service de Réanimation Médicale	Paris
France	Service de Réanimation Médicale et Resiratoire	Paris
France	Service de Réanimation	Poitiers
France	Service de Réanimation Médicale	Rouen
France	Service de Réanimation Médicale	Tours

Sponsors (1)

Lead Sponsor	Collaborator
Hôpital Louis Mourier

Country where clinical trial is conducted

France, 

References & 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, Béduneau G, Delétage-Métreau 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. — View 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. — View Citation

Roca O, Messika J, Caralt B, García-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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	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	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.	entire duration of high flow therapy (5 to 7 days)
Secondary	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.	entire duration of high flow therapy (5 to 7 days)
Secondary	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)	12 hours