Hypoxemia Clinical Trial
— DECIPHEROBSOfficial title:
Conduct of High Flow Nasal Cannula Oxygen During Acute Hypoxemic Respiratory Failure: a Multicentre Observational Study
NCT number | NCT03311087 |
Other study ID # | HLM_JDR6 |
Secondary ID | |
Status | Recruiting |
Phase | |
First received | |
Last updated | |
Start date | July 9, 2018 |
Est. completion date | November 2018 |
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.
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 |
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 |
Lead Sponsor | Collaborator |
---|---|
Hôpital Louis Mourier |
France,
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
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 |
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