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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.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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
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.

MICHEL GALINSKI, M.D, Ph.D contact

+33678549415

michel.galinski@chu-bordeaux.fr

France1 site, 1 recruiting
  • CHU de BORDEAUX - Hôpital Pellegrin - Pôle Urgences adultes - SAMU

    Bordeaux, 33000

    Recruiting

Other trials in France

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.

  1. Failure of the first intubation attempt

    Yes/No

    Measured: 1 hour

Secondary outcomes (22)
  1. Number of prior intubations done by operator ≤ 50

    yes/No

    Measured: 1 hour

  2. Operator position during intubation

    Upright/on knees/Lying on the floor/Lateral left decubitus/other

    Measured: 1 hour

  3. Gender

    Male/female

    Measured: 1 hour

  4. Age

    Year

    Measured: 1 hour

  5. Body mass index

    kg.m 2

    Measured: 1 hour

  6. Macroglossia

    yes/no

    Measured: 1 hour

  7. ENT tumor

    Yes/no

    Measured: 1 hour

  8. Inter-incisor space less than 2 fingerbreadths

    yes/no

    Measured: 1 hour

  9. limited head extension

    Yes/no

    Measured: 1 hour

  10. possible mandibular subluxation

    yes/no

    Measured: 1 hour

  11. thyromental length less than 3 fingerbreadths

    yes/no

    Measured: 1 hour

  12. Large neck size

    Yes/no

    Measured: 1 hour

  13. Foreign body in upper airway

    Yes/no

    Measured: 1 hour

  14. Upper airway bleeding/fluid

    Yes/no

    Measured: 1 hour

  15. Facial trauma

    Yes/no

    Measured: 1 hour

  16. Vomiting

    Yes/no

    Measured: 1 hour

  17. cardiorespiratory arrest

    yes/no

    Measured: 1 hour

  18. Patient on the floor

    Yes/no

    Measured: 1 hour

  19. Place where the intubation was done

    outside/at home/others/ambulance

    Measured: 1 hour

  20. restricted space

    Yes/no

    Measured: 1 hour

  21. if cardiac arrest, thoracic compression during intubation

    Yes/no

    Measured: 1 hour

  22. 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.

  1. First posted29 Dec 2021
  2. Study start20 May 2021
  3. Primary completion20 May 2022 (estimated)
  4. Study completion20 May 2022 (estimated)

Resources

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)
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

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.

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