Clinical trial NCT03486171: Tracheal Intubation and Prehospital Emergency Setting
Official title: Quality of Tracheal Intubation in Prehospital Emergency Setting and Measurement of Risk Factors of Difficult Intubation in This Context
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Tracheal Intubation Morbidity
Emergency Medicine
Keywords: difficult intubation
prehospital emergency
risk factors
Lead sponsor: University Hospital, Bordeaux
Sponsor class: OTHER
First posted: 2018-04-03
Enrollment: 1200
Sex: ALL
Minimum age (years): 10
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: All patients with life-threatening distress requiring emergency intubation.

Brief summary: In prehospital emergency setting, tracheal intubation is a frequent procedure (8% of interventions). Its objective is to control and protect upper airways and to optimize ventilation and oxygenation in patients with life-threatening distress. Intubation is a technical procedure which is associated with few difficulties with, in rare cases, the impossibility to do it. There are specificities of the out-of-hospital emergency with some risk factors that have been recognized in this context as well as the impossibility of assessing predictive factors of difficult intubation linked to the patient. The objective of the investigators was to describe the quality of tracheal intubation in prehospital emergency setting.

Detailed description: National and international guidelines have the objective to optimize the airway management modalities and to minimize the risk of complications in relation to this procedure. In contrast to the operating-room where intubation is performed daily in standardized conditions, in prehospital emergency setting, the environment and circumstances are variable and have an impact on the gesture as has been demonstrated. However, there are few studies about this issue, and these one are relatively ancients although that orotracheal intubation procedures in emergency are now well defined and that the algorithms for the management of difficult intubation have been well diffused in the emergency area these last 10 years. The last study about this topic has been published in 2012 involving more than 600 patients included between 2008 and 2010.

Difficult intubation rate, defined with a number of attempts over 2 or the use of an alternative technic was 11%. Another study with more than 2000 patients had found a rate of 6%. A study comparing the intubation difficulty scale score between two types of blades in 800 patients had found a rate of difficult intubation from 9 to 12%. The algorithms of the management of difficult intubation were largely based on the result of studies performed by anesthesiologists in operating ward. The objective will be to describe the quality of intubation and to measure risk factors of difficult intubation. The investigators are going to collect data about all patients intubated in prehospital emergency setting with the objective to measure the difficult intubation rate and to describe variables associated with difficult intubation. The follow up will be restricted to the area of prehospital emergency setting.

Eligibility criteria: Inclusion Criteria:

* all patients intubated by Emergency Medical System (EMS) team

Exclusion Criteria:

* none

Primary outcomes:
measure: Difficult intubation rate
timeFrame: One hour
Secondary outcomes:
measure: Risk factors of difficult intubation
timeFrame: one hour
measure: Patient characteristics
timeFrame: one hour
measure: Events during and after intubation
timeFrame: one hour
Other outcomes:
Locations:
city: Bordeaux
country: France
facility: CHU DE BORDEAUX- Hôpital PELLEGRIN - SAMU-SMUR 33
city: Garches
country: France
facility: Aphp, Hopital Raymond Poincare - Samu-Smur 92
city: Garges-lès-Gonesse
country: France
facility: Ch Garges Les Gonesses
city: Grenoble
country: France
facility: Chu de Grenoble - Samu-Smur 38
city: Périgueux
country: France
facility: Ch de Perigueux - Samu-Smur 24
Study officials:
affiliation: University Hospital, Bordeaux
name: MICHEL GALINSKI
role: PRINCIPAL_INVESTIGATOR
References: