Clinical trial NCT01699880: Efficacy of High Flow Nasal Cannula Oxygen to Reduce Desaturation During Tracheal Intubation
Official title: High Flow Nasal Cannula Oxygen for Pre and During Procedure Oxygenation During Tracheal Intubation: Comparison With High FiO2 Non Rebreathing Bag Reservoir Facemasks
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Need for Intubation
Oxygenation Before and During Intubation
Keywords: tracheal intubation
preoxygenation
desaturation
hypoxemia
oxygen therapy
high flow nasal cannula oxygen therapy
Lead sponsor: Hôpital Louis Mourier
Sponsor class: OTHER
First posted: 2012-10-04
Enrollment: 101
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: ICU patients requiring tracheal intubation

Brief summary: Tracheal intubation of critically ill patients is associated in the intensive care unit (ICU) with significant complications and morbidity. Patient desaturation is one of the most common complications that may lead to cardiac arrest despite pre-intubation oxygenation. Preoxygenation can be improved by the use of non-invasive ventilation, but this technique can be cumbersome to implement in the context of urgent intubation and more importantly it does not insure oxygenation during intubation. High flow nasal cannula oxygen therapy is a technique that has been shown to improve patient oxygenation in the context of acute hypoxemic respiratory failure. It bears the potential to be of clinical benefit in the setting of tracheal intubation in the ICU to ensure patient safety. The purpose of this study is to compare pre- and per-intubation (during intubation) oxygenation with either a conventional high FiO2 oxygen bag reservoir facemask (current standard practice) or high flow nasal cannula oxygen therapy (new practice to be implemented in our ICU).

Detailed description: Pre-oxygenation is ensured in our ICU with a high FiO2 nonrebreathing facemask, except in patients already under high flow nasal cannula oxygen therapy because of acute hypoxemic respiratory failure. A nasal catheter is positioned to ensure a low oxygen flow during laryngoscopy. Whether or not all patients should benefit from high flow nasal cannula oxygen therapy for pre-oxygenation remains unknown. In order to improve quality of care delivered to our patients and in anticipation of a change in our practice, we decided to record prospectively oxygen parameters during and immediately of intubation using a facemask and to compare them with parameters obtained in patients intubated after our change in practice. The change of practice consists in the systematic use of high flow nasal cannula oxygen therapy to ensure pre and during procedure (tracheal intubation)oxygenation.

Eligibility criteria: Inclusion Criteria:

* ICU patient requiring tracheal intubation

Exclusion Criteria:

* age \< 18 years
* cardiac arrest
* acute respiratory failure requiring immediate high flow nasal cannula oxygen, defined as patient with SpO2 \< 95% while under 15 L:min oxygen with a nonrebreathing facemask

Primary outcomes:
measure: lowest pulse oxymetry (SpO2) during intubation
timeFrame: from beginning of laryngoscopy to completed intubation
measure: mean pulse oxymetry during intubation
timeFrame: from beginning of laryngoscopy to completed intubation
measure: pulse oxymetry after preoxygenation
timeFrame: 3min prexoxygenation
measure: pulse oxymetry after intubation
timeFrame: at connection of the patient to the ventilator
Secondary outcomes:
measure: mean pulse oxymetry
timeFrame: one, five and thirty minutes after intubation
measure: number of pulse oxymetry below 90%
timeFrame: from laryngoscopy to 30 minutes once tracheal intubation completed
measure: number of pulse oxymetry below 80%
timeFrame: from laryngoscopy to 30 minutes once tracheal intubation completed
Other outcomes:
measure: cardiac arrest
timeFrame: during and immediately after procedure
measure: hemodynamic instability defined as arterial systolic blood pressure below 80 mmHg
timeFrame: during and immediately after procedure
Locations:
city: Colombes
country: France
facility: Medico-surgical ICU
Study officials:
affiliation: Hopital Louis Mourier, AP-HP, Colombes, France
name: Jean-Damien Ricard, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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: Ricard JD. High flow nasal oxygen in acute respiratory failure. Minerva Anestesiol. 2012 Jul;78(7):836-41. Epub 2012 Apr 24.
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: Lenglet H, Sztrymf B, Leroy C, Brun P, Dreyfuss D, Ricard JD. Humidified high flow nasal oxygen during respiratory failure in the emergency department: feasibility and efficacy. Respir Care. 2012 Nov;57(11):1873-8. doi: 10.4187/respcare.01575. Epub 2012 Mar 13.
citation: Miguel-Montanes R, Hajage D, Messika J, Bertrand F, Gaudry S, Rafat C, Labbe V, Dufour N, Jean-Baptiste S, Bedet A, Dreyfuss D, Ricard JD. Use of high-flow nasal cannula oxygen therapy to prevent desaturation during tracheal intubation of intensive care patients with mild-to-moderate hypoxemia. Crit Care Med. 2015 Mar;43(3):574-83. doi: 10.1097/CCM.0000000000000743.