Impact of the Bougie on the Prehospital Setting Intubation Quality.
- Conditions
- Tracheal Intubation MorbidityPrehospital Emergency
- Registration Number
- NCT05173220
- Lead Sponsor
- University Hospital, Bordeaux
- Brief 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.
- 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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 500
- all patients intubated by Emergency Medical System (EMS) team
- none
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Failure of the first intubation attempt 1 hour Yes/No
- Secondary Outcome Measures
Name Time Method side events /complications during the intubation until 30 minutes after 1 hour Yes/no
Gender 1 hour Male/female
if cardiac arrest, thoracic compression during intubation 1 hour Yes/no
Number of prior intubations done by operator ≤ 50 1 hour yes/No
Operator position during intubation 1 hour Upright/on knees/Lying on the floor/Lateral left decubitus/other
Age 1 hour Year
Body mass index 1 hour kg.m 2
Macroglossia 1 hour yes/no
ENT tumor 1 hour Yes/no
Inter-incisor space less than 2 fingerbreadths 1 hour yes/no
limited head extension 1 hour Yes/no
possible mandibular subluxation 1 hour yes/no
thyromental length less than 3 fingerbreadths 1 hour yes/no
Large neck size 1 hour Yes/no
Foreign body in upper airway 1 hour Yes/no
Upper airway bleeding/fluid 1 hour Yes/no
Facial trauma 1 hour Yes/no
Vomiting 1 hour Yes/no
cardiorespiratory arrest 1 hour yes/no
Patient on the floor 1 hour Yes/no
Place where the intubation was done 1 hour outside/at home/others/ambulance
restricted space 1 hour Yes/no
Trial Locations
- Locations (1)
CHU de BORDEAUX - Hôpital Pellegrin - Pôle Urgences adultes - SAMU
🇫🇷Bordeaux, France