Impact of the Bougie on the Prehospital Setting Intubation Quality. (SMURIDS2)

Tracheal Intubation in Emergency Prehospital Setting. Impact of the Bougie on the Failure Rate of First Intubation Attempt.

Tracheal intubation in an out-of-hospital setting is a frequent and potentially difficult procedure. The risk of adverse events increases dramatically with the number of attempts. The failure rate of the first intubation attempt ranges from 5 to 32% and the risk factors are unclear.

In recent study, the prevalence of a failed first intubation attempt was 31.4% [95% CI = 30.2-32.6] among 1546 patients managed in an out-of-hospital setting. In this multicenter study, our center (N=462) had a rate of 36% of failure of the first attempt. Seven variables were independently associated with a failed first intubation attempt. Some of the associated factors can be improved (operator training and experience), but most cannot. Moreover some of them can not be anticipated in this context. A randomized control trial performed in an emergency department and a prospective, observational, pre-post study design showed that systematic use of a bougie during the first intubation attempt improved the success rate.

Our objective is to measure the impact of a modification of our intubation modalities introducing the incitation of the use of the bougie on the first intubation attempt in the prehospital setting.

Study Overview

• Status: Recruiting
• Conditions: Tracheal Intubation Morbidity; Prehospital Emergency

Detailed Description

Tracheal intubation (TI) is a procedure that is frequently performed in an out-of-hospital emergency setting. TI is associated with a risk of adverse events, including severe sequelae such as hypoxemia, vomiting, aspiration, hypotension, and cardiac arrest. The risk of adverse events increases dramatically with the number of intubation attempts. Thus, it is important that the first intubation attempt succeeds. In most cases, the environment in an out-of-hospital setting is not appropriate for intubation, and can be austere (outside, restricted space, patient on the floor, or public place) or dangerous (mountain, sea, or roadside). Although literature data are abundant, they are extremely heterogenous. Indeed, the available studies differ in terms of operator profiles, TI indications, and design. Based on studies involving management by physician-led teams in out-of-hospital settings and for which data are available, the failure rate of the first intubation attempt ranges from 5% to 32%. Numerous variables are associated with difficult intubation (DI), such as more than two attempts and bad glottic visualization, but few studies have analyzed risk factors for failure of the first attempt. Identification of such factors would decrease the risk of complications.In recent study, the prevalence of a failed first intubation attempt was 31.4% [95% CI = 30.2-32.6] among 1546 patients managed in an out-of-hospital setting. In this multicenter study, our center (N=462) had a rate of 36% of failure of the first attempt. Seven variables were independently associated with a failed first intubation attempt, operator with ≤ 50 prior intubations, small inter-incisor space, limited head extension, macroglossia, ENT tumor, cardiac arrest, and vomiting.

Some of the associated factors can be improved (operator training and experience), but most cannot. Moreover some of them can not be anticipated in this context. A randomized control trial performed in an emergency department showed that systematic use of a bougie during the first intubation attempt improved the success rate. A prospective, observational, pre-post study design including 823 and 771 patients respectively, showed that the use of a bougie on the first intubation attempt by paramedic in prehospital setting, improved the success rate. So we modified our intubation modalities introducing the incitation of the use of the bougie on the first intubation attempt in the prehospital setting.

The main objective of this study is to compare the rate of first intubation attempt in a new observational study performed in our center with the rate of the first assessment and to measure the impact of the introduction a systematic bougie in our intubation modalities. The secondary objective is to measure in this new cohorte rate of first intubation attempt between intubation with and without bougie.

The follow up will be restricted to the area of prehospital emergency setting.

• Study Type: Observational
• Enrollment (Anticipated): 500

Contacts and Locations

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

Study Locations

• France
  • Bordeaux, France, 33000
    • Recruiting
    • CHU de BORDEAUX - Hôpital Pellegrin - Pôle Urgences adultes - SAMU

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 15 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
Failure of the first intubation attempt	Yes/No	1 hour

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of prior intubations done by operator ≤ 50	yes/No	1 hour
Operator position during intubation	Upright/on knees/Lying on the floor/Lateral left decubitus/other	1 hour
Gender	Male/female	1 hour
Age	Year	1 hour
Body mass index	kg.m 2	1 hour
Macroglossia	yes/no	1 hour
ENT tumor	Yes/no	1 hour
Inter-incisor space less than 2 fingerbreadths	yes/no	1 hour
limited head extension	Yes/no	1 hour
possible mandibular subluxation	yes/no	1 hour
thyromental length less than 3 fingerbreadths	yes/no	1 hour
Large neck size	Yes/no	1 hour
Foreign body in upper airway	Yes/no	1 hour
Upper airway bleeding/fluid	Yes/no	1 hour
Facial trauma	Yes/no	1 hour
Vomiting	Yes/no	1 hour
cardiorespiratory arrest	yes/no	1 hour
Patient on the floor	Yes/no	1 hour
Place where the intubation was done	outside/at home/others/ambulance	1 hour
restricted space	Yes/no	1 hour
if cardiac arrest, thoracic compression during intubation	Yes/no	1 hour
side events /complications during the intubation until 30 minutes after	Yes/no	1 hour

Collaborators and Investigators

• Sponsor: University Hospital, Bordeaux
• Collaborators: Bruno Simonnet
• Investigators: Principal Investigator: MICHEL GALINSKI, M.D, Ph.D, University Hospital, Bordeaux; Principal Investigator: BRUNO SIMONNET, M.D, University Hospital, Bordeaux

Study record dates

Study Major Dates

• Study Start (Actual): May 20, 2021
• Primary Completion (Anticipated): May 20, 2022
• Study Completion (Anticipated): May 20, 2022

Study Registration Dates

• First Submitted: December 8, 2021
• First Submitted That Met QC Criteria: December 10, 2021
• First Posted (Actual): December 29, 2021

Study Record Updates

• Last Update Posted (Actual): December 29, 2021
• Last Update Submitted That Met QC Criteria: December 10, 2021
• Last Verified: December 1, 2021

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-02

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No