IntubationAIRWAYNCT02900807
CT-scan Airways Mensuration - Correlation to External Measurements
An observational study of Intubation, run by Fondation Ophtalmologique Adolphe de Rothschild at 1 site in France.
Trial summary
Oro-tracheal intubation is performed daily in anesthesia and in the ICU. When a patient is intubated, the endotracheal tube must be inserted into the trachea to the right depth. If the tube is not deep Inserted enough there is a risk of accidental extubation and trauma to the vocal cords by the balloon. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Intubation
- How many people
- 134 participants
- Where
- 1 siteFrance
- Study dates
- Sep 2014to 23 Mar 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: Patient scheduled for a CT-scan including the airways and the upper part of the chest until the hull
Who may be able to join
- patient scheduled for a CT-scan including the airways and the upper part of the chest at least until the carina
- patient size between between 150 cm and 195 cm
Who cannot join
- significant deformity of the cervical spine to accurately measure the size of patients (kyphoscoliosis...)
- impossibility of reliably know the size of the patient
- history of pharyngo-laryngeal surgery resulting in a significant deformity or a loss of anatomical landmarks incompatible with reliable measurements between dental arches and glottic plan (total laryngectomy...)
- history of lung surgery not allowing reliable location of the carina (pneumonectomy, double-lung transplant)
Trial locations and contacts
1 site in 1 country.
About this study
Oro-tracheal intubation is performed daily in anesthesia and in the ICU. When a patient is intubated, the endotracheal tube must be inserted into the trachea to the right depth. If the tube is not deep Inserted enough there is a risk of accidental extubation and trauma to the vocal cords by the balloon. If the tube is inserted too far there is a risk of selective intubation into the right or left mainstem bronchus, which can lead to contralateral lung atelectasis and hypoxemia.
The purpose of this study is to determine whether there is a correlation between the measurement of the airway of an adult population and criteria that would be easily accessible in daily clinical practice: the height of the patient and the size of their feet.
- Conditions
- Intubation
What is being measured
The primary outcome is the main question the study is designed to answer.
size of the patients and/or size of their feet
measured with a height chart and/or a pedometer
Measured: Duration of the CT-scan : about 1 hour
measurement of patients' airways
Mensurations of airways measured on imaging (CT-scan)
Measured: Duration of the CT-scan : about 1 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2016 (estimated)
- Study startSep 2014
- Primary completionDec 2014
- Study completion23 Mar 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for IntubationStudies of the same condition, open and under way.
- More trials run by Fondation Ophtalmologique Adolphe de RothschildThe 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
- 134 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fondation Ophtalmologique Adolphe de Rothschild
- Sponsor type
- Research network
- Responsible party
- Sponsor
- Investigators
- Guillaume Taylor, MD, Study director, Fondation OPH A de Rothschild
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02900807
- Sponsor's protocol ID
- GTR_2014_24
- Acronym
- AIRWAY
- Status last verified
- Feb 2018
- First submitted
- 7 Sep 2016
- Last updated
- 9 Aug 2018
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- CT-scan Airways Mensuration - Correlation to External Measurements
- ClinicalTrials.gov ID
- NCT02900807
- Acronym / sponsor ID
- AIRWAY / GTR_2014_24
- Conditions
- Intubation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 134 participants (actual)
- Lead sponsor
- Fondation Ophtalmologique Adolphe de RothschildResearch network
- Study start
- Sep 2014 (actual)
- Primary completion
- Dec 2014 (actual)
- Study completion
- 23 Mar 2017 (actual)
- First posted
- 14 Sep 2016 (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.
Oro-tracheal intubation is performed daily in anesthesia and in the ICU. When a patient is intubated, the endotracheal tube must be inserted into the trachea to the right depth. If the tube is not deep Inserted enough there is a risk of accidental extubation and trauma to the vocal cords by the balloon. If the tube is inserted too far there is a risk of selective intubation into the right or left mainstem bronchus, which can lead to contralateral lung atelectasis and hypoxemia.
The purpose of this study is to determine whether there is a correlation between the measurement of the airway of an adult population and criteria that would be easily accessible in daily clinical practice: the height of the patient and the size of their feet.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patient scheduled for a CT-scan including the airways and the upper part of the chest until the hull
Key inclusion criteria (2 listed)
- patient scheduled for a CT-scan including the airways and the upper part of the chest at least until the carina
- patient size between between 150 cm and 195 cm
Key exclusion criteria (4 listed)
- significant deformity of the cervical spine to accurately measure the size of patients (kyphoscoliosis...)
- impossibility of reliably know the size of the patient
- history of pharyngo-laryngeal surgery resulting in a significant deformity or a loss of anatomical landmarks incompatible with reliable measurements between dental arches and glottic plan (total laryngectomy...)
- history of lung surgery not allowing reliable location of the carina (pneumonectomy, double-lung transplant)
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
size of the patients and/or size of their feet
Time frame: Duration of the CT-scan : about 1 hour
measured with a height chart and/or a pedometer
measurement of patients' airways
Time frame: Duration of the CT-scan : about 1 hour
Mensurations of airways measured on imaging (CT-scan)
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 9 Aug 2018.
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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.
Guillaume Taylor, MD study director
Fondation OPH A de Rothschild
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 Intubation, run by Fondation Ophtalmologique Adolphe de Rothschild 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 4 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 9 Aug 2018. 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?
size of the patients and/or size of their feet (time frame: Duration of the CT-scan : about 1 hour). The study lists 2 primary outcomes in all. 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 9 Aug 2018.