High Flow Nasal Canula Oxygen Helps Preoxygenate ARDS Patients

Acute Respiratory Distress Syndrome Clinical Trial

— HIGHER  

Official title:

Observational Study of High Flow Nasal Canula Oxygen to Preoxygenate ARDS Patients That Require Intubation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02214576
• Other study ID #: HLM_JDR2
• Status: Completed
• Phase: N/A
• First received: August 11, 2014
• Last updated: August 13, 2015
• Start date: September 2011
• Est. completion date: August 2015

Study information

• Verified date: August 2015
• Source: Hôpital Louis Mourier
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Ministère de l'Enseignement supérieur et de la RechercheFrance: Ministry of Health
• Study type: Observational

Clinical Trial Summary

Tracheal intubation in the ICU is associated with significant complications and morbidity. Desaturation is among the most frequent and hazardous complication, occurring in almost one out of four intubations, that may in some instances lead to cardiac arrest; despite appropriate preoxygenation. Non-invasive ventilation may help improve preoxygenation but does not allow for apneic oxygenation and may not be performed in patients with neurological impairment. High flow nasal canula oxygen is increasingly used in the ICU in patients with acute hypoxemic respiratory failure and may be used to improve preoxygenation. It is currently used in our ICU for that purpose. Because high flow nasal canula oxygen is our first line oxyten therapy for patients with acute respirtory distress syndrome, we sought to determine its use as a means to ensure preoxygenation in those ARDS patients that require intubation.

Description:

High flow nasal canula oxygen is increasingly used to provide heated and humidified oxygen in patients with acute respiratory failure. One of the major advantages of high flow nasal canula oxygen is the possibility to maintain oxygenation during laryngoscopy and thereby providing high flow apneic oxygenation. In addition, and contrary no non-invasive ventilation, preoxygenation may be used in patients with neurological impairment. Finally, the interest of this device is that it is the same that is maintained throughout the whole management of the patient, from ICU admission to intubation.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: August 2015
• Est. primary completion date: August 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• ARDS according to the Berlin criteria

• use of high flow nasal canula oxygen

Exclusion Criteria:

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Acute Lung Injury
• Acute Respiratory Distress Syndrome
• Respiratory Distress Syndrome, Adult
• Respiratory Distress Syndrome, Newborn

Locations

Country	Name	City	State
France	Medico-surgical ICU, Louis Mourier Hospital	Colombes

Sponsors (1)

Lead Sponsor	Collaborator
Hôpital Louis Mourier

Country where clinical trial is conducted

France, 

References & Publications (4)

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

Ricard JD. High flow nasal oxygen in acute respiratory failure. Minerva Anestesiol. 2012 Jul;78(7):836-41. Epub 2012 Apr 24. Review. — 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	Oxygen saturation	oxygen saturation measured by pulse oxymetry during intubation and compared to levels before intubation	30 minutes	Yes
Secondary	complications	arrhythmia, hypotension, profound desaturation, cardiac arrest	60 minutes	Yes