LaryngoscopyNCT00799357
Utility of Bedside Ultrasound in the Prediction of Difficult Airway
An observational study of Laryngoscopy, run by University of Nebraska at 1 site in United States.
Trial summary
The purpose of this study is to assess the utility of bedside ultrasound to predict difficult airway in patients requiring emergency intubation. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Laryngoscopy
- How many people
- 162 participants
- Where
- 1 siteUnited States
- Study dates
- 9 Dec 2008to 1 Jun 2009
- 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 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Pre-op patients
Who may be able to join
- Patients scheduled for any surgery under general anesthesia with endotracheal intubation
Who cannot join
- Upper airway pathologies (facial fractures, tumours, etc)
- Cervical spine fractures
- Tracheostomy tube
- unable to give consent
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Nebraska Medical Center
Omaha, Nebraska, 68198
About this study
The purpose of this study is to assess the utility of bedside ultrasound to predict difficult airway in patients requiring emergency intubation.
Read the detailed description
A variety of pre-intubation clinical screening tests have been advocated to predict difficult laryngoscopy, but their usefulness is limited in emergency department, intensive care unit, pre-hospital and combat settings. Patients in these settings are often confused, lethargic, obtunded, uncooperative and common screening tests for difficult laryngoscopy cannot be applied in a large number of emergency intubations. In the recent past, there has been growing interest in upper airway ultrasound. The purpose of this study is to assess the utility of bedside ultrasound to predict difficult airway in patients requiring emergency intubation.
- Conditions
- Laryngoscopy
- Keywords
- ultrasound
What is being measured
The primary outcome is the main question the study is designed to answer.
Predictors of difficult laryngoscopy
Measured: one day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Nov 2008 (estimated)
- Study start9 Dec 2008
- Primary completion1 Jun 2009
- Study completion1 Jun 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for LaryngoscopyStudies of the same condition, open and under way.
- More trials run by University of NebraskaThe 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
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 162 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Nebraska
- Sponsor type
- University, hospital or other
- Collaborators
- The Association for Medical Ultrasound
- Responsible party
- Sponsor
- Investigators
- Srikar R Adhikari, Principal investigator, University of Nebraska
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00799357
- Sponsor's protocol ID
- 0526-08-EP
- Status last verified
- Aug 2023
- First submitted
- 26 Nov 2008
- Last updated
- 30 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
Publications
Komatsu R, Sengupta P, Wadhwa A, Akca O, Sessler DI, Ezri T, Lenhardt R. Ultrasound quantification of anterior soft tissue thickness fails to predict difficult laryngoscopy in obese patients. Anaesth Intensive Care. 2007 Feb;35(1):32-7. doi: 10.1177/0310057X0703500104.
PubMed 17323663Ezri T, Gewurtz G, Sessler DI, Medalion B, Szmuk P, Hagberg C, Susmallian S. Prediction of difficult laryngoscopy in obese patients by ultrasound quantification of anterior neck soft tissue. Anaesthesia. 2003 Nov;58(11):1111-4. doi: 10.1046/j.1365-2044.2003.03412.x.
PubMed 14616599Chou HC, Wu TL. Large hypopharyngeal tongue: a shared anatomic abnormality for difficult mask ventilation, difficult intubation, and obstructive sleep apnea? Anesthesiology. 2001 May;94(5):936-7. doi: 10.1097/00000542-200105000-00043. No abstract available.
PubMed 11388555
Study at a glance
From the registry record, last updated by the sponsor on 30 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Utility of Bedside Ultrasound in the Prediction of Difficult Airway
- ClinicalTrials.gov ID
- NCT00799357
- Acronym / sponsor ID
- 0526-08-EP
- Conditions
- Laryngoscopy
- Keywords
- ultrasound
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 162 participants (estimated)
- Lead sponsor
- University of NebraskaUniversity, hospital or other
- Collaborators
- The Association for Medical Ultrasound
- Study start
- 9 Dec 2008 (actual)
- Primary completion
- 1 Jun 2009 (actual)
- Study completion
- 1 Jun 2009 (actual)
- First posted
- 27 Nov 2008 (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 assess the utility of bedside ultrasound to predict difficult airway in patients requiring emergency intubation.
Detailed description
A variety of pre-intubation clinical screening tests have been advocated to predict difficult laryngoscopy, but their usefulness is limited in emergency department, intensive care unit, pre-hospital and combat settings. Patients in these settings are often confused, lethargic, obtunded, uncooperative and common screening tests for difficult laryngoscopy cannot be applied in a large number of emergency intubations. In the recent past, there has been growing interest in upper airway ultrasound. The purpose of this study is to assess the utility of bedside ultrasound to predict difficult airway in patients requiring emergency intubation.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Pre-op patients
Key inclusion criteria (1 listed)
- Patients scheduled for any surgery under general anesthesia with endotracheal intubation
Key exclusion criteria (4 listed)
- Upper airway pathologies (facial fractures, tumours, etc)
- Cervical spine fractures
- Tracheostomy tube
- unable to give consent
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
Predictors of difficult laryngoscopy
Time frame: one 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 30 Aug 2023.
- Results publication: PubMed 17323663Komatsu R, Sengupta P, Wadhwa A, Akca O, Sessler DI, Ezri T, Lenhardt R. Ultrasound quantification of anterior soft tissue thickness fails to predict difficult laryngoscopy in obese patients. Anaesth Intensive Care. 2007 Feb;35(1):32-7. doi: 10.1177/0310057X0703500104.
- Results publication: PubMed 14616599Ezri T, Gewurtz G, Sessler DI, Medalion B, Szmuk P, Hagberg C, Susmallian S. Prediction of difficult laryngoscopy in obese patients by ultrasound quantification of anterior neck soft tissue. Anaesthesia. 2003 Nov;58(11):1111-4. doi: 10.1046/j.1365-2044.2003.03412.x.
- Results publication: PubMed 11388555Chou HC, Wu TL. Large hypopharyngeal tongue: a shared anatomic abnormality for difficult mask ventilation, difficult intubation, and obstructive sleep apnea? Anesthesiology. 2001 May;94(5):936-7. doi: 10.1097/00000542-200105000-00043. No abstract available.
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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.
Srikar R Adhikari principal investigator
University of Nebraska
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 Laryngoscopy, run by University of Nebraska 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 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 30 Aug 2023. 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. 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?
Predictors of difficult laryngoscopy (time frame: one day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00799357, which also lists 3 linked publications.
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 30 Aug 2023.