Impact of the Bougie on the Prehospital Setting Intubation Quality.

Tracheal Intubation Morbidity Clinical Trial

— SMURIDS2  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05173220
• Other study ID #: CHUBX-URG-02
• Status: Recruiting
• Start date: May 20, 2021
• Est. completion date: May 20, 2022

Study information

• Verified date: December 2021
• Source: University Hospital, Bordeaux
• Contact: MICHEL GALINSKI, M.D, Ph.D
• Phone: +33678549415
• Email: michel.galinski[@]chu-bordeaux.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 500
• Est. completion date: May 20, 2022
• Est. primary completion date: May 20, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 15 Years and older

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• none

Related Conditions & MeSH terms

• Emergencies
• Prehospital Emergency
• Tracheal Intubation Morbidity

Locations

Country	Name	City	State
France	CHU de BORDEAUX - Hôpital Pellegrin - Pôle Urgences adultes - SAMU	Bordeaux

Sponsors (2)

Lead Sponsor	Collaborator
University Hospital, Bordeaux	Bruno Simonnet

Country where clinical trial is conducted

France, 

Outcome

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