Tracheal Intubation and Prehospital Emergency Setting

Emergency Medicine Clinical Trial

— SMURIDS  

Official title:

Quality of Tracheal Intubation in Prehospital Emergency Setting and Measurement of Risk Factors of Difficult Intubation in This Context

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03486171
• Other study ID #: CHUBX-URG-01
• Status: Recruiting
• 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
• 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:

Related Conditions & MeSH terms

• Emergencies
• Emergency Medicine
• Tracheal Intubation Morbidity

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