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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03486171
Other study ID # CHUBX-URG-01
Secondary ID
Status Recruiting
Phase
First received January 24, 2018
Last updated March 26, 2018
Start date March 1, 2017
Est. completion date September 1, 2018

Study information

Verified date March 2018
Source University Hospital, Bordeaux
Contact MICHEL GALINSKI, M.D; Ph.D.
Phone +335.56.79.48.26
Email michel.galinski@chu-bordeaux.fr
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 1200
Est. completion date September 1, 2018
Est. primary completion date May 31, 2018
Accepts healthy volunteers No
Gender All
Age group 10 Years and older
Eligibility Inclusion Criteria:

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

Exclusion Criteria:

Study Design


Locations

Country Name City State
France CHU DE BORDEAUX- Hôpital PELLEGRIN - SAMU-SMUR 33 Bordeaux
France Aphp, Hopital Raymond Poincare - Samu-Smur 92 Garches
France Ch Garges Les Gonesses Garges-lès-Gonesse
France Chu de Grenoble - Samu-Smur 38 Grenoble
France Ch de Perigueux - Samu-Smur 24 Périgueux

Sponsors (1)

Lead Sponsor Collaborator
University Hospital, Bordeaux

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary Difficult intubation rate Difficult intubation is defined with an Intubation Difficult Scale score > 5; Intubation Difficult Sale (IDS) is ranged from 0 (easy intubation) to infinity (impossibility to intubate trachea). One hour
Secondary Risk factors of difficult intubation Circumstances of intubation (outside/inside), patient on the floor or not, cardiac arrest or not and if yes resuscitation during the intubation or not, nature of the drugs for sedation during rapid sequence induction, pharyngeal or laryngeal hemorrhage. one hour
Secondary Patient characteristics sex , age, body mass index, acute disease (trauma or medical), criteria associated with difficult airway access (mouth opening, thyroid-chin distance, neck circumference), pharyngeal or laryngeal tumor. one hour
Secondary Events during and after intubation desaturation, vomiting, low blood pressure, tachycardia or bradycardia, cardiac arrest, others. one hour
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