Tracheal Intubation and Prehospital Emergency Setting (SMURIDS)

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

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.

Study Overview

• Status: Unknown
• Conditions: Emergency Medicine; Tracheal Intubation Morbidity

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.

• Study Type: Observational
• Enrollment (Anticipated): 1200

Contacts and Locations

• Study Contact: Name: MICHEL GALINSKI, M.D; Ph.D.; Phone Number: +335.56.79.48.26; Email: michel.galinski@chu-bordeaux.fr
• Study Contact Backup: Name: MICHEL GALINSKI; Phone Number: +33678549415

Study Locations

• France
  • Bordeaux, France, 33000
    • Recruiting
    • CHU DE BORDEAUX- Hôpital PELLEGRIN - SAMU-SMUR 33
    • Contact: MICHEL GALINSKI, M.D, Ph.D; Phone Number: +335.56.79.48.26; Email: michel.galinski@chu-bordeaux.fr
    • Principal Investigator: MICHEL GALINSKI, M.D, Ph.D
    • Sub-Investigator: ROMAIN BOYER, M.D
    • Sub-Investigator: MARION WROBEL, M.D
  • Garches, France, 92380
    • Recruiting
    • Aphp, Hopital Raymond Poincare - Samu-Smur 92
    • Contact: PAUL-GEORGES REUTER
    • Principal Investigator: PAUL-GEORGES REUTER, M.D, MSc
  • Garges-lès-Gonesse, France, 95141
    • Recruiting
    • Ch Garges Les Gonesses
    • Contact: MIRKO RUSCEV
    • Principal Investigator: MIRKO RUSCEV, M.D
  • Grenoble, France, 38000
    • Recruiting
    • Chu de Grenoble - Samu-Smur 38
    • Contact: GUILLAUME DEBATY
    • Principal Investigator: GUILLAUME DEBATY, M.D, Ph.D
  • Périgueux, France, 24000
    • Recruiting
    • Ch de Perigueux - Samu-Smur 24
    • Contact: JEAN-PAUL LORENDEAU
    • Principal Investigator: JEAN-PAUL LORENDEAU, M.D

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 10 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

All patients with life-threatening distress requiring emergency intubation.

Description

Inclusion Criteria:

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

Exclusion Criteria:

• none

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
Events during and after intubation	desaturation, vomiting, low blood pressure, tachycardia or bradycardia, cardiac arrest, others.	one hour

Collaborators and Investigators

• Sponsor: University Hospital, Bordeaux
• Investigators: Principal Investigator: MICHEL GALINSKI, University Hospital, Bordeaux

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2017
• Primary Completion (Anticipated): May 31, 2018
• Study Completion (Anticipated): September 1, 2018

Study Registration Dates

• First Submitted: January 24, 2018
• First Submitted That Met QC Criteria: March 26, 2018
• First Posted (Actual): April 3, 2018

Study Record Updates

• Last Update Posted (Actual): April 3, 2018
• Last Update Submitted That Met QC Criteria: March 26, 2018
• Last Verified: March 1, 2018

More Information

Terms related to this study

• Keywords: risk factors; difficult intubation; prehospital emergency
• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Emergencies
• Other Study ID Numbers: CHUBX-URG-01

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No