Skip to content

Impact of the Bougie on the Prehospital Setting Intubation Quality.

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

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05173220
Acronym
SMURIDS2
Enrollment
500
Registered
2021-12-29
Start date
2021-05-20
Completion date
2022-05-20
Last updated
2021-12-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Prehospital Emergency, Tracheal Intubation Morbidity

Keywords

difficult intubation, prehospital emergency, risk factors

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.

Interventions

None listed

Sponsors

Bruno Simonnet
CollaboratorUNKNOWN
University Hospital, Bordeaux
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
15 Years to No maximum
Healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

* none

Design outcomes

Primary

MeasureTime frameDescription
Failure of the first intubation attempt1 hourYes/No

Secondary

MeasureTime frameDescription
Operator position during intubation1 hourUpright/on knees/Lying on the floor/Lateral left decubitus/other
Gender1 hourMale/female
Age1 hourYear
Body mass index1 hourkg.m 2
Macroglossia1 houryes/no
ENT tumor1 hourYes/no
Inter-incisor space less than 2 fingerbreadths1 houryes/no
limited head extension1 hourYes/no
possible mandibular subluxation1 houryes/no
thyromental length less than 3 fingerbreadths1 houryes/no
Number of prior intubations done by operator ≤ 501 houryes/No
Foreign body in upper airway1 hourYes/no
Upper airway bleeding/fluid1 hourYes/no
Facial trauma1 hourYes/no
Vomiting1 hourYes/no
cardiorespiratory arrest1 houryes/no
Patient on the floor1 hourYes/no
Place where the intubation was done1 houroutside/at home/others/ambulance
restricted space1 hourYes/no
if cardiac arrest, thoracic compression during intubation1 hourYes/no
side events /complications during the intubation until 30 minutes after1 hourYes/no
Large neck size1 hourYes/no

Countries

France

Contacts

Primary ContactMICHEL GALINSKI, M.D, Ph.D
michel.galinski@chu-bordeaux.fr+33678549415

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026