Selective Bronchial TubeSBINCT03204656
Selective Bronchial Intubation (SBI)
An observational study of Selective Bronchial Tube, run by Centre Chirurgical Marie Lannelongue at 1 site in France.
Trial summary
Difficult orotracheal intubation carries a risk of hemodynamic collapse, neurological sequelae secondary to cerebral anoxia or death. Anesthetic scores and predictive indices are used to predict difficulties and avoid complications for usual tracheal intubation. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Selective Bronchial Tube
- How many people
- 200 participants
- Where
- 1 siteFrance
- Study dates
- 20 Feb 2017to 20 May 2017
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All adult patients with intubation during surgery in Marie Lannelongue's hospital
Who may be able to join
- For adult patients : age greater than or equal to 18 years
- Patients with thoracic, cardiac, vascular or plastic surgery
Who cannot join
- Intubations performed before admission to the operating room or catheterization room;
- Patient whose age is less than 18 years
- Traditional re-intubation at the end of the procedure after a selective lung IOT;
- Selective re-intubation in a patient previously intubated on arrival at the operating theater;
- IOT in other departments of the HML (intensive care, Pulmonary Postoperative Unit (UPOP), bronchoscopy, hospitalization services, Intensive Care Unit (ICU), etc.).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Selective Bronchial Intubation (SBI) at Marie Lannelongue Hospital (HML) : Epidemiology of Expected and Unexpected Difficult Intubations.
Difficult orotracheal intubation carries a risk of hemodynamic collapse, neurological sequelae secondary to cerebral anoxia or death. Anesthetic scores and predictive indices are used to predict difficulties and avoid complications for usual tracheal intubation. However, existing indices are not adapted to selective bronchial intubations.
The aim of the study is to determine the incidence of unexpected difficult SBI using conventional screening tests. It is a prospective descriptive epidemiological monocentric study comparing two groups of patients (selective vs. non selective intubations).
- Conditions
- Selective Bronchial Tube
- Keywords
- difficult orotracheal intubation, selective lung intubation, unexpected difficult selective lung intubation
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of difficult selective bronchial intubation
Rate (percentage)
Measured: 1 day
Secondary outcomes (1)
Predictive factors of difficult selective bronchial intubation
questionnaire
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jul 2017
- Study start20 Feb 2017
- Primary completion20 May 2017
- Study completion20 May 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Selective Bronchial TubeStudies of the same condition, open and under way.
- 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
- Other
- Time perspective
- Prospective
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Chirurgical Marie Lannelongue
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03204656
- Sponsor's protocol ID
- 2016-A02070-51
- Acronym
- SBI
- Status last verified
- May 2017
- First submitted
- 22 Mar 2017
- Last updated
- 2 Jul 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Selective Bronchial Intubation (SBI) at Marie Lannelongue Hospital (HML) : Epidemiology of Expected and Unexpected Difficult Intubations.
- ClinicalTrials.gov ID
- NCT03204656
- Acronym / sponsor ID
- SBI / 2016-A02070-51
- Conditions
- Selective Bronchial Tube
- Keywords
- difficult orotracheal intubation, selective lung intubation, unexpected difficult selective lung intubation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Centre Chirurgical Marie LannelongueUniversity, hospital or other
- Study start
- 20 Feb 2017 (actual)
- Primary completion
- 20 May 2017 (actual)
- Study completion
- 20 May 2017 (actual)
- First posted
- 2 Jul 2017 (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.
Difficult orotracheal intubation carries a risk of hemodynamic collapse, neurological sequelae secondary to cerebral anoxia or death. Anesthetic scores and predictive indices are used to predict difficulties and avoid complications for usual tracheal intubation. However, existing indices are not adapted to selective bronchial intubations.
The aim of the study is to determine the incidence of unexpected difficult SBI using conventional screening tests. It is a prospective descriptive epidemiological monocentric study comparing two groups of patients (selective vs. non selective intubations).
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All adult patients with intubation during surgery in Marie Lannelongue's hospital
Key inclusion criteria (2 listed)
- For adult patients : age greater than or equal to 18 years
- Patients with thoracic, cardiac, vascular or plastic surgery
Key exclusion criteria (5 listed)
- Intubations performed before admission to the operating room or catheterization room;
- Patient whose age is less than 18 years
- Traditional re-intubation at the end of the procedure after a selective lung IOT;
- Selective re-intubation in a patient previously intubated on arrival at the operating theater;
- IOT in other departments of the HML (intensive care, Pulmonary Postoperative Unit (UPOP), bronchoscopy, hospitalization services, Intensive Care Unit (ICU), etc.).
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
Rate of difficult selective bronchial intubation
Time frame: 1 day
Rate (percentage)
1 secondary outcome
Predictive factors of difficult selective bronchial intubation
Time frame: 1 day
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jul 2017.
- Individual participant dataSharing planned: No
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.
The record lists no contact. Use the official record to reach the sponsor.
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 Selective Bronchial Tube, run by Centre Chirurgical Marie Lannelongue 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 2 inclusion and 5 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: finished, as of the sponsor's last update on 2 Jul 2017. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of difficult selective bronchial intubation (time frame: 1 day). 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 2 Jul 2017.