Clinical trial NCT05173220: Impact of the Bougie on the Prehospital Setting Intubation Quality.
Official title: Tracheal Intubation in Emergency Prehospital Setting. Impact of the Bougie on the Failure Rate of First Intubation Attempt.
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Tracheal Intubation Morbidity
Prehospital Emergency
Keywords: difficult intubation
prehospital emergency
risk factors
Lead sponsor: University Hospital, Bordeaux
Sponsor class: OTHER
Collaborators: name: Bruno Simonnet
First posted: 2021-12-29
Enrollment: 500
Sex: ALL
Minimum age (years): 15
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: All patients with life-threatening distress requiring emergency intubation.

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.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* none

Primary outcomes:
measure: Failure of the first intubation attempt
timeFrame: 1 hour
Secondary outcomes:
measure: Number of prior intubations done by operator ≤ 50
timeFrame: 1 hour
measure: Operator position during intubation
timeFrame: 1 hour
measure: Gender
timeFrame: 1 hour
measure: Age
timeFrame: 1 hour
measure: Body mass index
timeFrame: 1 hour
measure: Macroglossia
timeFrame: 1 hour
measure: ENT tumor
timeFrame: 1 hour
measure: Inter-incisor space less than 2 fingerbreadths
timeFrame: 1 hour
measure: limited head extension
timeFrame: 1 hour
measure: possible mandibular subluxation
timeFrame: 1 hour
measure: thyromental length less than 3 fingerbreadths
timeFrame: 1 hour
measure: Large neck size
timeFrame: 1 hour
measure: Foreign body in upper airway
timeFrame: 1 hour
measure: Upper airway bleeding/fluid
timeFrame: 1 hour
measure: Facial trauma
timeFrame: 1 hour
measure: Vomiting
timeFrame: 1 hour
measure: cardiorespiratory arrest
timeFrame: 1 hour
measure: Patient on the floor
timeFrame: 1 hour
measure: Place where the intubation was done
timeFrame: 1 hour
measure: restricted space
timeFrame: 1 hour
measure: if cardiac arrest, thoracic compression during intubation
timeFrame: 1 hour
measure: side events /complications during the intubation until 30 minutes after
timeFrame: 1 hour
Other outcomes:
Locations:
city: Bordeaux
country: France
facility: CHU de BORDEAUX - Hôpital Pellegrin - Pôle Urgences adultes - SAMU
Study officials:
affiliation: University Hospital, Bordeaux
name: MICHEL GALINSKI, M.D, Ph.D
role: PRINCIPAL_INVESTIGATOR
affiliation: University Hospital, Bordeaux
name: BRUNO SIMONNET, M.D
role: PRINCIPAL_INVESTIGATOR
References: