Tracheal Intubation MorbiditySMURIDSNCT03486171
Tracheal Intubation and Prehospital Emergency Setting
An observational study of Tracheal Intubation Morbidity and Emergency Medicine, run by University Hospital, Bordeaux at 5 sites in France.
Trial summary
In prehospital emergency setting, tracheal intubation is a frequent procedure (8% of interventions). Its objective is to control and protect upper airways and to optimize ventilation and oxygenation in patients with life-threatening distress. Read more about this study
- Who is it for?
- Ages 10 years and older
- Conditions the study is for
- Tracheal Intubation Morbidity, Emergency Medicine
- How many people
- 1,200 participants
- Where
- 5 sitesFrance
- Study dates
- 1 Mar 2017to 1 Sep 2018
- 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 10 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
5 sites in 1 country.
MICHEL GALINSKI contact
5 sites in 1 country
France5 sites, 5 recruiting
- Recruiting
CHU DE BORDEAUX- Hôpital PELLEGRIN - SAMU-SMUR 33
Bordeaux, 33000
MICHEL GALINSKI, M.D, Ph.D, +335.56.79.48.26, michel.galinski@chu-bordeaux.fr
MICHEL GALINSKI, M.D, Ph.D
- Recruiting
Aphp, Hopital Raymond Poincare - Samu-Smur 92
Garches, 92380
PAUL-GEORGES REUTER
PAUL-GEORGES REUTER, M.D, MSc
- Recruiting
Ch Garges Les Gonesses
Garges-lès-Gonesse, 95141
MIRKO RUSCEV
MIRKO RUSCEV, M.D
- Recruiting
Chu de Grenoble - Samu-Smur 38
Grenoble, 38000
GUILLAUME DEBATY
GUILLAUME DEBATY, M.D, Ph.D
- Recruiting
Ch de Perigueux - Samu-Smur 24
Périgueux, 24000
JEAN-PAUL LORENDEAU
JEAN-PAUL LORENDEAU, M.D
About this study
Official title: Quality of Tracheal Intubation in Prehospital Emergency Setting and Measurement of Risk Factors of Difficult Intubation in This Context
In prehospital emergency setting, tracheal intubation is a frequent procedure (8% of interventions). Its objective is to control and protect upper airways and to optimize ventilation and oxygenation in patients with life-threatening distress. Intubation is a technical procedure which is associated with few difficulties with, in rare cases, the impossibility to do it. There are specificities of the out-of-hospital emergency with some risk factors that have been recognized in this context as well as the impossibility of assessing predictive factors of difficult intubation linked to the patient. The objective of the investigators was to describe the quality of tracheal intubation in prehospital emergency setting.
Read the detailed description
National and international guidelines have the objective to optimize the airway management modalities and to minimize the risk of complications in relation to this procedure. In contrast to the operating-room where intubation is performed daily in standardized conditions, in prehospital emergency setting, the environment and circumstances are variable and have an impact on the gesture as has been demonstrated. However, there are few studies about this issue, and these one are relatively ancients although that orotracheal intubation procedures in emergency are now well defined and that the algorithms for the management of difficult intubation have been well diffused in the emergency area these last 10 years. The last study about this topic has been published in 2012 involving more than 600 patients included between 2008 and 2010.
Difficult intubation rate, defined with a number of attempts over 2 or the use of an alternative technic was 11%. Another study with more than 2000 patients had found a rate of 6%. A study comparing the intubation difficulty scale score between two types of blades in 800 patients had found a rate of difficult intubation from 9 to 12%. The algorithms of the management of difficult intubation were largely based on the result of studies performed by anesthesiologists in operating ward. The objective will be to describe the quality of intubation and to measure risk factors of difficult intubation. The investigators are going to collect data about all patients intubated in prehospital emergency setting with the objective to measure the difficult intubation rate and to describe variables associated with difficult intubation. The follow up will be restricted to the area of prehospital emergency setting.
- Conditions
- Tracheal Intubation Morbidity, Emergency Medicine
- Keywords
- difficult intubation, prehospital emergency, risk factors
What is being measured
The primary outcome is the main question the study is designed to answer.
Difficult intubation rate
Difficult intubation is defined with an Intubation Difficult Scale score > 5; Intubation Difficult Sale (IDS) is ranged from 0 (easy intubation) to infinity (impossibility to intubate trachea).
Measured: One hour
Secondary outcomes (3)
Risk factors of difficult intubation
Circumstances of intubation (outside/inside), patient on the floor or not, cardiac arrest or not and if yes resuscitation during the intubation or not, nature of the drugs for sedation during rapid sequence induction, pharyngeal or laryngeal hemorrhage.
Measured: one hour
Patient characteristics
sex , age, body mass index, acute disease (trauma or medical), criteria associated with difficult airway access (mouth opening, thyroid-chin distance, neck circumference), pharyngeal or laryngeal tumor.
Measured: one hour
Events during and after intubation
desaturation, vomiting, low blood pressure, tachycardia or bradycardia, cardiac arrest, others.
Measured: one hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Apr 2018
- Study start1 Mar 2017
- Primary completion31 May 2018 (estimated)
- Study completion1 Sep 2018 (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
- 1,200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Bordeaux
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Michel GALINSKI, University Hospital, Bordeaux
- Investigators
- MICHEL GALINSKI, Principal investigator, University Hospital, Bordeaux
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03486171
- Sponsor's protocol ID
- CHUBX-URG-01
- Acronym
- SMURIDS
- Status last verified
- Mar 2018
- First submitted
- 24 Jan 2018
- Last updated
- 3 Apr 2018
- 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 3 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Quality of Tracheal Intubation in Prehospital Emergency Setting and Measurement of Risk Factors of Difficult Intubation in This Context
- ClinicalTrials.gov ID
- NCT03486171
- Acronym / sponsor ID
- SMURIDS / CHUBX-URG-01
- Conditions
- Tracheal Intubation Morbidity, Emergency Medicine
- Keywords
- difficult intubation, prehospital emergency, risk factors
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,200 participants (estimated)
- Lead sponsor
- University Hospital, BordeauxUniversity, hospital or other
- Study start
- 1 Mar 2017 (actual)
- Primary completion
- 31 May 2018 (estimated)
- Study completion
- 1 Sep 2018 (estimated)
- First posted
- 3 Apr 2018 (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.
In prehospital emergency setting, tracheal intubation is a frequent procedure (8% of interventions). Its objective is to control and protect upper airways and to optimize ventilation and oxygenation in patients with life-threatening distress. Intubation is a technical procedure which is associated with few difficulties with, in rare cases, the impossibility to do it. There are specificities of the out-of-hospital emergency with some risk factors that have been recognized in this context as well as the impossibility of assessing predictive factors of difficult intubation linked to the patient. The objective of the investigators was to describe the quality of tracheal intubation in prehospital emergency setting.
Detailed description
National and international guidelines have the objective to optimize the airway management modalities and to minimize the risk of complications in relation to this procedure. In contrast to the operating-room where intubation is performed daily in standardized conditions, in prehospital emergency setting, the environment and circumstances are variable and have an impact on the gesture as has been demonstrated. However, there are few studies about this issue, and these one are relatively ancients although that orotracheal intubation procedures in emergency are now well defined and that the algorithms for the management of difficult intubation have been well diffused in the emergency area these last 10 years. The last study about this topic has been published in 2012 involving more than 600 patients included between 2008 and 2010.
Difficult intubation rate, defined with a number of attempts over 2 or the use of an alternative technic was 11%. Another study with more than 2000 patients had found a rate of 6%. A study comparing the intubation difficulty scale score between two types of blades in 800 patients had found a rate of difficult intubation from 9 to 12%. The algorithms of the management of difficult intubation were largely based on the result of studies performed by anesthesiologists in operating ward. The objective will be to describe the quality of intubation and to measure risk factors of difficult intubation. The investigators are going to collect data about all patients intubated in prehospital emergency setting with the objective to measure the difficult intubation rate and to describe variables associated with difficult intubation. 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
- 10 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
Difficult intubation rate
Time frame: One hour
Difficult intubation is defined with an Intubation Difficult Scale score > 5; Intubation Difficult Sale (IDS) is ranged from 0 (easy intubation) to infinity (impossibility to intubate trachea).
3 secondary outcomes
Risk factors of difficult intubation
Time frame: one hour
Patient characteristics
Time frame: one hour
Events during and after intubation
Time frame: one hour
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Apr 2018.
Related trials for Tracheal Intubation Morbidity
Recruiting
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 contact
MICHEL GALINSKI principal investigator
University Hospital, Bordeaux
5 sites 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 Emergency Medicine, run by University Hospital, Bordeaux at 5 sites 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 3 Apr 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites 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. (+335.56.79.48.26, 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?
Difficult intubation rate (time frame: One 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 3 Apr 2018.