Intubation; DifficultTUBECHONCT02362568
Study of Interest on Cervical Ultrasound Exploration for Association With Difficult Intubation
A study testing Ultrasound cervical exploration in people with Intubation; Difficult, run by Centre Hospitalier Universitaire de Besancon at 2 sites in France.
Trial summary
The purpose of this study is to determine if cervical ultrasound exploration can predict difficult intubation better than main validated clinical criteria. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Intubation; Difficult
- What is being tested?
- Ultrasound cervical exploration
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 462 participants
- Where
- 2 sitesFrance
- Study dates
- Oct 2013to Apr 2015
- Phase
- Interventional
- 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
Who may be able to join
- Age over 18
- patient consent
Who cannot join
- patient nonconsent
- age under 18
- cervical surgery
Trial locations and contacts
2 sites in 1 country.
France2 sites
CHRU de Besançon
Besançon, Franche Comte, 25000
CHU Besancon Minjoz
Besançon, 25000
About this study
Official title: Human Study of Interest on Cervical Ultrasound Exploration for Association With Criteria of Difficult Intubation in General Surgery
The purpose of this study is to determine if cervical ultrasound exploration can predict difficult intubation better than main validated clinical criteria.
Read the detailed description
The purpose of this study is to determine if cervical ultrasound exploration can predict difficult intubation better than main validated clinical criteria in general surgery.
- Conditions
- Intubation; Difficult
- Being tested
- Ultrasound cervical exploration
- Keywords
- Intubation; Difficult
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ultrasound cervical explorationProcedure or surgery
The cervical ultrasound exploration will consist in the ultrasound measurement of the length between the hyoid bone and the skin and the length between the thyroid cartilage and the skin. The ultrasound cervical exploration will be performed in all patients admitted in the postoperative room after a planned surgery performed under general anesthesia.
| Study group | Role | What they receive |
|---|---|---|
| Cervical ultrasound exploration | No intervention | A cervical ultrasound exploration will be performed in all patients admitted for a planned surgery performed under general anesthesia during the stay in the postoperative room. Receives: Procedure: Ultrasound cervical exploration |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sensibility, Specificity, predictive positive and negative values of US cervical measures relationship between the hyoid bone and thyroid cartilage with difficult intubation
The measure of the length between the hyoid bone and the skin and between the thyroid cartilage and the skin will be measured using an ultrasound cervical exploration in all patients admitted in the postoperative room after planned surgery performed under general anesthesia.
Measured: Day 1
Secondary outcomes (2)
Sensibility, specificity and predictive positive and negative values of validated clinical criteria for difficult intubation
The collect of usual clinical criteria of difficult intubation in postoperative room of patients who undergo a general anesthesia for a surgery
Measured: Day 1
Mortality and morbidity of difficult intubation
Collect any complications (hypoxia, hypotension, tooth breakage) assigned to a difficult intubation during general anesthesia for surgery.
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2015 (estimated)
- Study startOct 2013
- Primary completionApr 2015
- Study completionApr 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intubation; DifficultStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de BesanconThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 462 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Besancon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Boinette Romain, MD, Principal investigator, Centre Hospitalier Universitaire de Besancon
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02362568
- Sponsor's protocol ID
- P/2013/181
- Acronym
- TUBECHO
- Status last verified
- Aug 2016
- First submitted
- 28 Jan 2014
- Last updated
- 31 Aug 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 31 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Human Study of Interest on Cervical Ultrasound Exploration for Association With Criteria of Difficult Intubation in General Surgery
- ClinicalTrials.gov ID
- NCT02362568
- Acronym / sponsor ID
- TUBECHO / P/2013/181
- Conditions
- Intubation; Difficult
- Keywords
- Intubation; Difficult
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 462 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de BesanconUniversity, hospital or other
- Study start
- Oct 2013
- Primary completion
- Apr 2015 (actual)
- Study completion
- Apr 2015 (actual)
- First posted
- 13 Feb 2015 (estimated)
- 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.
The purpose of this study is to determine if cervical ultrasound exploration can predict difficult intubation better than main validated clinical criteria.
Detailed description
The purpose of this study is to determine if cervical ultrasound exploration can predict difficult intubation better than main validated clinical criteria in general surgery.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cervical ultrasound exploration | No intervention | Procedure: Ultrasound cervical explorationA cervical ultrasound exploration will be performed in all patients admitted for a planned surgery performed under general anesthesia during the stay in the postoperative room. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Age over 18
- patient consent
Key exclusion criteria (3 listed)
- patient nonconsent
- age under 18
- cervical surgery
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ultrasound cervical explorationThe cervical ultrasound exploration will consist in the ultrasound measurement of the length between the hyoid bone and the skin and the length between the thyroid cartilage and the skin. The ultrasound cervical exploration will be performed in all patients admitted in the postoperative room after a planned surgery performed under general anesthesia. | Procedure or surgery | Cervical ultrasound exploration |
Primary outcome
Sensibility, Specificity, predictive positive and negative values of US cervical measures relationship between the hyoid bone and thyroid cartilage with difficult intubation
Time frame: Day 1
The measure of the length between the hyoid bone and the skin and between the thyroid cartilage and the skin will be measured using an ultrasound cervical exploration in all patients admitted in the postoperative room after planned surgery performed under general anesthesia.
2 secondary outcomes
Sensibility, specificity and predictive positive and negative values of validated clinical criteria for difficult intubation
Time frame: Day 1
Mortality and morbidity of difficult intubation
Time frame: Day 1
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 31 Aug 2016.
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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.
Boinette Romain, MD principal investigator
Centre Hospitalier Universitaire de Besancon
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ultrasound cervical exploration in people with Intubation; Difficult, run by Centre Hospitalier Universitaire de Besancon at 2 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 2 inclusion and 3 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 31 Aug 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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?
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?
Sensibility, Specificity, predictive positive and negative values of US cervical measures relationship between the hyoid bone and thyroid cartilage with difficult intubation (time frame: Day 1). 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 31 Aug 2016.