Failed or Difficult IntubationNCT01630694
Three-dimensional Craniofacial Phenotyping of Patients With Difficult Airway
A study testing 3D Laser Scanning of the Head, Measurements and Digital Photo's of the head, neck and Mouth and Ultrasound Exam of the Tongue in people with Failed or Difficult Intubation, run by University of Rochester at 1 site in United States.
Trial summary
The purpose of this study is to identify differences in craniofacial morphology and tongue size between patients who have a history of difficult airway management and a control group of patients who had an uneventful airway management during induction of general anesthesia. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Failed or Difficult Intubation
- What is being tested?
- 3D Laser Scanning of the Head, Measurements and Digital Photo's of the head, neck and Mouth and Ultrasound Exam of the Tongue
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 28 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2010to Oct 2012
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patients that had undergone or will undergo a surgery under general anesthesia .
Who cannot join
- known history of syndromal craniofacial abnormalities (e.g. Down syndrome)
- previous craniofacial surgery
- excessive facial hair which significantly obscure facial landmarks
- cervical spine fractures
- tracheostomy tube
- patients who are unable to give consent
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Rochester Medical Center
Rochester, New York, 14642
About this study
Official title: Three -Dimensional (3-D) Craniofacial Phenotyping of Patients With Difficult Airway
The purpose of this study is to identify differences in craniofacial morphology and tongue size between patients who have a history of difficult airway management and a control group of patients who had an uneventful airway management during induction of general anesthesia. In this study the investigators want to validate the hypothesis that there are craniofacial phenotypic differences between patients who have a history of difficult airway management and a control group of patients who have had an uneventful airway management during the induction of general anesthesia.
Read the detailed description
Difficult airway management is one of the most challenging tasks for anesthesiologists. Recent data from the American Society of Anesthesiologists (ASA) Management Closed Claims Project [1] show that the percentage of claims resulting from adverse respiratory events, though on the decline (42% in the 1980s to 32% in the 1990s), continue to constitute a large source of morbidity and mortality in anesthetized patients. In 2005, a closed claims analysis of trends in anesthesia-related death and brain damage between 1975 and 2000 showed that out of all respiratory events (n=503) responsible for death and brain damage, difficult endotracheal intubation (n=115), inadequate oxygenation (n=111) and inadvertent esophageal intubation (n=66) were the top three causes [2].
- Conditions
- Failed or Difficult Intubation
- Being tested
- 3D Laser Scanning of the Head, Measurements and Digital Photo's of the head, neck and Mouth, Ultrasound Exam of the Tongue
- Keywords
- Difficult airway management, anesthesia, difficult intubation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
3D Laser Scanning of the HeadProcedure or surgery
Also called Konica Minolta 3D Digitizing Konica Minolta 3D laser scanner
Five scans will be collected from different angles, each scan taking approximately 3 seconds. Each scan will consist of a thin beam of light flashing of your head.
Measurements and Digital Photo's of the head, neck and MouthProcedure or surgery
Also called General Electric Total access ultrasound
Prior to the photographs, certain bone and soft tissue areas such as angle of the jaw, neck and chin will be gently touched and marked with self-adhesive paper stickers. Using the self-adhesive paper stickers and a measuring tape, we obtain measurements of your head and neck. You will be also asked to open your mouth and a digital photograph of the back of the mouth will be taken, as well as, pictures of the front and side of the head and neck.
Ultrasound Exam of the TongueProcedure or surgery
Also called General Electric Total access ultrasound
The ultrasound study of the tongue will be performed after the series of laser scans. You will be examined in the sitting position. A small,handheld, curved ultrasound instrument will be placed under the chin to take images of the tongue. This exam should take less than a minute
3D Laser Scanning of the HeadProcedure or surgery
Also called 3D digitizing Konica Minolta 3D laser scanner
Five scans will be collected from different angles, each scan taking approximately 3 seconds. Each scan will consist of a thin beam of light flashing of your head.
Measurements and Digital Photo's of the head, neck and MouthProcedure or surgery
Also called 3D digitizing konica minolta 3D laser scanner
Prior to the photographs, certain bone and soft tissue areas such as angle of the jaw, neck and chin will be gently touched and marked with self-adhesive paper stickers. Using the self-adhesive paper stickers and a measuring tape, we obtain measurements of your head and neck.Digital Photographs of your Mouth - You will be also asked to open your mouth and a digital photograph of the back of the mouth will be taken, as well as, pictures of the front and side of the head and neck.
Ultrasound Exam of the TongueProcedure or surgery
Also called General Electric Total Access ultrasound
The ultrasound study of the tongue will be performed after the series of laser scans. You will be examined in the sitting position. A small,handheld, curved ultrasound instrument will be placed under the chin to take images of the tongue. This exam should take less than a minute.
| Study group | Role | What they receive |
|---|---|---|
| Difficult intubation patients | Active comparator | patients who were difficult to intubate during previous anesthetics provided by the staff anesthesiologists. Receives: Procedure: 3D Laser Scanning of the Head; Procedure: Measurements and Digital Photo's of the head, neck and Mouth; Procedure: Ultrasound Exam of the Tongue |
| Control | Placebo comparator | The control group will consist of patients with the easy laryngoscopy and intubation, recruited prospectively. Receives: Procedure: 3D Laser Scanning of the Head; Procedure: Measurements and Digital Photo's of the head, neck and Mouth; Procedure: Ultrasound Exam of the Tongue |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean Hyomental Distance Ratio
A curved low-frequency transducer and a Flex focul 400 ultrasound system were used to visualize the tongue and shadows of the hyoid bone and mandible. Midsagittal and coronal/transverse scans from the ultrasound were analyzed using ImageJ. The hyomental distances in the neutral and heal-extended positions were measured from the upper border of the hyoid bone to the lower border of the mentum. The ratio is defined as the ratio of the hyomental distance at the extreme of head extension to that in the neutral position.
Measured: end of study approximately one year
Secondary outcomes (1)
Mean Tongue Volume
The midsagittal scans were used to measure the cross-sectional area of the tongue. Transverse scans obtained in the midsection of the tongue (at the glossal end of the genioglossus muscle) provided a measure of the tongue width, which was measured between the most distant points on its upper surface. The tongue volume was derived from the multiplication of the midsagittal cross-sectional area by the tongue width.
Measured: end of study approximately one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jun 2012 (estimated)
- Study startJul 2010
- Primary completionOct 2012
- Study completionOct 2012
Why it stopped: study stopped due to not meeting enrollment goal.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Failed or Difficult IntubationStudies of the same condition, open and under way.
- More trials run by University of RochesterThe 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Rochester
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jacek Wojtczak, University of Rochester
- Investigators
- Jacek Wojtczak, MD, Principal investigator, University of Rochester
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01630694
- Sponsor's protocol ID
- RSRB case number: 00032136
- Status last verified
- Dec 2015
- First submitted
- 16 Aug 2011
- Last updated
- 20 Jan 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Three -Dimensional (3-D) Craniofacial Phenotyping of Patients With Difficult Airway
- ClinicalTrials.gov ID
- NCT01630694
- Acronym / sponsor ID
- RSRB case number: 00032136
- Conditions
- Failed or Difficult Intubation
- Keywords
- Difficult airway management, anesthesia, difficult intubation
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: study stopped due to not meeting enrollment goal.
- Enrolment
- 28 participants (actual)
- Lead sponsor
- University of RochesterUniversity, hospital or other
- Study start
- Jul 2010
- Primary completion
- Oct 2012 (actual)
- Study completion
- Oct 2012 (actual)
- First posted
- 28 Jun 2012 (estimated)
- Results
- Posted 20 Jan 2016
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 identify differences in craniofacial morphology and tongue size between patients who have a history of difficult airway management and a control group of patients who had an uneventful airway management during induction of general anesthesia. In this study the investigators want to validate the hypothesis that there are craniofacial phenotypic differences between patients who have a history of difficult airway management and a control group of patients who have had an uneventful airway management during the induction of general anesthesia.
Detailed description
Difficult airway management is one of the most challenging tasks for anesthesiologists. Recent data from the American Society of Anesthesiologists (ASA) Management Closed Claims Project [1] show that the percentage of claims resulting from adverse respiratory events, though on the decline (42% in the 1980s to 32% in the 1990s), continue to constitute a large source of morbidity and mortality in anesthetized patients. In 2005, a closed claims analysis of trends in anesthesia-related death and brain damage between 1975 and 2000 showed that out of all respiratory events (n=503) responsible for death and brain damage, difficult endotracheal intubation (n=115), inadequate oxygenation (n=111) and inadvertent esophageal intubation (n=66) were the top three causes [2].
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Difficult intubation patients | Active comparator | Procedure: 3D Laser Scanning of the Head, Procedure: Measurements and Digital Photo's of the head, neck and Mouth, Procedure: Ultrasound Exam of the Tonguepatients who were difficult to intubate during previous anesthetics provided by the staff anesthesiologists. |
| Control | Placebo comparator | Procedure: 3D Laser Scanning of the Head, Procedure: Measurements and Digital Photo's of the head, neck and Mouth, Procedure: Ultrasound Exam of the TongueThe control group will consist of patients with the easy laryngoscopy and intubation, recruited prospectively. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- patients that had undergone or will undergo a surgery under general anesthesia .
Key exclusion criteria (6 listed)
- known history of syndromal craniofacial abnormalities (e.g. Down syndrome)
- previous craniofacial surgery
- excessive facial hair which significantly obscure facial landmarks
- cervical spine fractures
- tracheostomy tube
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 |
|---|---|---|
| 3D Laser Scanning of the HeadAlso: Konica Minolta 3D Digitizing Konica Minolta 3D laser scannerFive scans will be collected from different angles, each scan taking approximately 3 seconds. Each scan will consist of a thin beam of light flashing of your head. | Procedure or surgery | Control |
| Measurements and Digital Photo's of the head, neck and MouthAlso: General Electric Total access ultrasoundPrior to the photographs, certain bone and soft tissue areas such as angle of the jaw, neck and chin will be gently touched and marked with self-adhesive paper stickers. Using the self-adhesive paper stickers and a measuring tape, we obtain measurements of your head and neck. You will be also asked to open your mouth and a digital photograph of the back of the mouth will be taken, as well as, pictures of the front and side of the head and neck. | Procedure or surgery | Control |
| Ultrasound Exam of the TongueAlso: General Electric Total access ultrasoundThe ultrasound study of the tongue will be performed after the series of laser scans. You will be examined in the sitting position. A small,handheld, curved ultrasound instrument will be placed under the chin to take images of the tongue. This exam should take less than a minute | Procedure or surgery | Control |
| 3D Laser Scanning of the HeadAlso: 3D digitizing Konica Minolta 3D laser scannerFive scans will be collected from different angles, each scan taking approximately 3 seconds. Each scan will consist of a thin beam of light flashing of your head. | Procedure or surgery | Difficult intubation patients |
| Measurements and Digital Photo's of the head, neck and MouthAlso: 3D digitizing konica minolta 3D laser scannerPrior to the photographs, certain bone and soft tissue areas such as angle of the jaw, neck and chin will be gently touched and marked with self-adhesive paper stickers. Using the self-adhesive paper stickers and a measuring tape, we obtain measurements of your head and neck.Digital Photographs of your Mouth - You will be also asked to open your mouth and a digital photograph of the back of the mouth will be taken, as well as, pictures of the front and side of the head and neck. | Procedure or surgery | Difficult intubation patients |
| Ultrasound Exam of the TongueAlso: General Electric Total Access ultrasoundThe ultrasound study of the tongue will be performed after the series of laser scans. You will be examined in the sitting position. A small,handheld, curved ultrasound instrument will be placed under the chin to take images of the tongue. This exam should take less than a minute. | Procedure or surgery | Difficult intubation patients |
Primary outcome
Mean Hyomental Distance Ratio
Time frame: end of study approximately one year
A curved low-frequency transducer and a Flex focul 400 ultrasound system were used to visualize the tongue and shadows of the hyoid bone and mandible. Midsagittal and coronal/transverse scans from the ultrasound were analyzed using ImageJ. The hyomental distances in the neutral and heal-extended positions were measured from the upper border of the hyoid bone to the lower border of the mentum. The ratio is defined as the ratio of the hyomental distance at the extreme of head extension to that in the neutral position.
1 secondary outcome
Mean Tongue Volume
Time frame: end of study approximately one year
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jan 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related trials for Failed or Difficult Intubation
Not yet recruitingObservational study
Can the "Face Index"; an Anthropometric Measurement, Predict Difficult Laryngoscopy and Intubation?
Anesthesia Intubation Complication, Laryngoscopy
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PrediSuisse: Automatized Assessment of Difficult Airway
Anesthesia, Intubation; Difficult or Failed
RecruitingObservational study
Difficult Airway Prediction by Integrating STOP-BANG Criteria
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RecruitingObservational study
Improving Safety and Quality of Tracheal Intubation Practice in Pediatric ICUs
Failed or Difficult Intubation, Sequela, Intubation; Difficult
Active, not recruitingObservational study
Data-driven Development of a Core Dataset for Difficult Airway Alerts
Airway Management, Intubation; Difficult or Failed
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.
Jacek Wojtczak, MD principal investigator
University of Rochester
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 3D Laser Scanning of the Head, Measurements and Digital Photo's of the head, neck and Mouth and Ultrasound Exam of the Tongue in people with Failed or Difficult Intubation, run by University of Rochester at 1 site in United States.
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 6 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: stopped early, as of the sponsor's last update on 20 Jan 2016. 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 United States. 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. Some participants in this study may receive a placebo. 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?
Yes. Results are posted in the registry (first posted 20 Jan 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Mean Hyomental Distance Ratio (time frame: end of study approximately one year). 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 20 Jan 2016.