Tracheal Intubation MorbiditySMURIDS2NCT05173220
Impact of the Bougie on the Prehospital Setting Intubation Quality.
An observational study of Tracheal Intubation Morbidity and Prehospital Emergency, run by University Hospital, Bordeaux at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 15 years and older
- Conditions the study is for
- Tracheal Intubation Morbidity, Prehospital Emergency
- How many people
- 500 participants
- Where
- 1 siteFrance
- Study dates
- 20 May 2021to 20 May 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 15 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: All patients with life-threatening distress requiring emergency intubation.
Who may be able to join
- all patients intubated by Emergency Medical System (EMS) team
Who cannot join
- none
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
CHU de BORDEAUX - Hôpital Pellegrin - Pôle Urgences adultes - SAMU
Bordeaux, 33000
About this study
Official title: 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.
Read the 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.
- Keywords
- difficult intubation, prehospital emergency, risk factors
What is being measured
The primary outcome is the main question the study is designed to answer.
Failure of the first intubation attempt
Yes/No
Measured: 1 hour
Secondary outcomes (22)
Number of prior intubations done by operator ≤ 50
yes/No
Measured: 1 hour
Operator position during intubation
Upright/on knees/Lying on the floor/Lateral left decubitus/other
Measured: 1 hour
Gender
Male/female
Measured: 1 hour
Age
Year
Measured: 1 hour
Body mass index
kg.m 2
Measured: 1 hour
Macroglossia
yes/no
Measured: 1 hour
ENT tumor
Yes/no
Measured: 1 hour
Inter-incisor space less than 2 fingerbreadths
yes/no
Measured: 1 hour
limited head extension
Yes/no
Measured: 1 hour
possible mandibular subluxation
yes/no
Measured: 1 hour
thyromental length less than 3 fingerbreadths
yes/no
Measured: 1 hour
Large neck size
Yes/no
Measured: 1 hour
Foreign body in upper airway
Yes/no
Measured: 1 hour
Upper airway bleeding/fluid
Yes/no
Measured: 1 hour
Facial trauma
Yes/no
Measured: 1 hour
Vomiting
Yes/no
Measured: 1 hour
cardiorespiratory arrest
yes/no
Measured: 1 hour
Patient on the floor
Yes/no
Measured: 1 hour
Place where the intubation was done
outside/at home/others/ambulance
Measured: 1 hour
restricted space
Yes/no
Measured: 1 hour
if cardiac arrest, thoracic compression during intubation
Yes/no
Measured: 1 hour
side events /complications during the intubation until 30 minutes after
Yes/no
Measured: 1 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Dec 2021
- Study start20 May 2021
- Primary completion20 May 2022 (estimated)
- Study completion20 May 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tracheal Intubation MorbidityStudies of the same condition, open and under way.
- More trials run by University Hospital, BordeauxThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Bordeaux
- Sponsor type
- University, hospital or other
- Collaborators
- Bruno Simonnet
- Responsible party
- Principal investigator, Michel GALINSKI, University Hospital, Bordeaux
- Investigators
- MICHEL GALINSKI, M.D, Ph.D, Principal investigator, University Hospital, BordeauxBRUNO SIMONNET, M.D, Principal investigator, University Hospital, Bordeaux
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05173220
- Sponsor's protocol ID
- CHUBX-URG-02
- Acronym
- SMURIDS2
- Status last verified
- Dec 2021
- First submitted
- 8 Dec 2021
- Last updated
- 29 Dec 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tracheal Intubation in Emergency Prehospital Setting. Impact of the Bougie on the Failure Rate of First Intubation Attempt.
- ClinicalTrials.gov ID
- NCT05173220
- Acronym / sponsor ID
- SMURIDS2 / CHUBX-URG-02
- Keywords
- difficult intubation, prehospital emergency, risk factors
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- University Hospital, BordeauxUniversity, hospital or other
- Collaborators
- Bruno Simonnet
- Study start
- 20 May 2021 (actual)
- Primary completion
- 20 May 2022 (estimated)
- Study completion
- 20 May 2022 (estimated)
- First posted
- 29 Dec 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 15 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- All patients with life-threatening distress requiring emergency intubation.
Key inclusion criteria (1 listed)
- all patients intubated by Emergency Medical System (EMS) team
Key exclusion criteria (1 listed)
- none
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Failure of the first intubation attempt
Time frame: 1 hour
Yes/No
22 secondary outcomes
Number of prior intubations done by operator ≤ 50
Time frame: 1 hour
Operator position during intubation
Time frame: 1 hour
Gender
Time frame: 1 hour
Age
Time frame: 1 hour
Body mass index
Time frame: 1 hour
Macroglossia
Time frame: 1 hour
ENT tumor
Time frame: 1 hour
Inter-incisor space less than 2 fingerbreadths
Time frame: 1 hour
limited head extension
Time frame: 1 hour
possible mandibular subluxation
Time frame: 1 hour
thyromental length less than 3 fingerbreadths
Time frame: 1 hour
Large neck size
Time frame: 1 hour
Foreign body in upper airway
Time frame: 1 hour
Upper airway bleeding/fluid
Time frame: 1 hour
Facial trauma
Time frame: 1 hour
Vomiting
Time frame: 1 hour
cardiorespiratory arrest
Time frame: 1 hour
Patient on the floor
Time frame: 1 hour
Place where the intubation was done
Time frame: 1 hour
restricted space
Time frame: 1 hour
if cardiac arrest, thoracic compression during intubation
Time frame: 1 hour
side events /complications during the intubation until 30 minutes after
Time frame: 1 hour
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Dec 2021.
Related trials for Tracheal Intubation Morbidity
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Optimisation Strategy for Emergency Tracheal Intubation
Emergencies, Out-of-hospital Setting
Not yet recruitingPhase 2/3
Oral Melatonin VS Nebulized Dexmedetomidine Premedication on Attenuation of Hemodynamic Response to Direct Laryngoscopy and Tracheal Intubation in Hypertensive Patients
Tracheal Intubation Morbidity, Laryngoscopy
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
MICHEL GALINSKI, M.D, Ph.D principal investigator
University Hospital, Bordeaux
BRUNO SIMONNET, M.D principal investigator
University Hospital, Bordeaux
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Tracheal Intubation Morbidity and Prehospital Emergency, run by University Hospital, Bordeaux at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 29 Dec 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact MICHEL GALINSKI, M.D, Ph.D (+33678549415, michel.galinski@chu-bordeaux.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Failure of the first intubation attempt (time frame: 1 hour). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Dec 2021.