Difficult LaryngoscopyNCT01719848
Evaluation of Clinical Airway Assessments With a Gray Zone Approach
An observational study of Difficult Laryngoscopy, run by Samsung Medical Center at 1 site in South Korea.
Trial summary
Failure of advanced airway security has been reported that it could lead lethal complication such as brain hypoxic damage. There have been controversial reports for the airway assessment tests which can predict difficult laryngoscopy. Read more about this study
- Who is it for?
- Ages 20 to 80 years
- Conditions the study is for
- Difficult Laryngoscopy
- What is being tested?
- Measurements of parameters related with physical examinations for difficult airway prediction
- How many people
- 200 participants
- Where
- 1 siteSouth Korea
- Study dates
- Aug 2012to Jul 2013
- 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 20 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients undergoing general anesthesia for any surgery at Samsung medical center
Who may be able to join
- 20 to 80 years old patients undergoing general anesthesia for any operation.
Who cannot join
- previous difficult airway history
- upper airway obstruction disease
- congenital disorders that are known to relate with difficult airway
- neurologic symptom associated with neck extension
- emergent operation
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of Clinical Airway Assessments for Predicting Difficult Laryngoscopy Using a Gray Zone Approach
Failure of advanced airway security has been reported that it could lead lethal complication such as brain hypoxic damage. There have been controversial reports for the airway assessment tests which can predict difficult laryngoscopy. Therefore, we evaluated diagnostic validity of pre-existing airway assessment tests and scoring system using a gray zone approach in patients undergoing general anesthesia required endotracheal intubation.
Read the detailed description
POGO(percentage of glottic opening)will be evaluated by an attachable fiberoptic scope (AV scope. CAREtec CO.Ltd, Kangwon-Do, South Korea)
- Conditions
- Difficult Laryngoscopy
- Being tested
- Measurements of parameters related with physical examinations for difficult airway prediction
- Keywords
- Physical examinations, Percentage of glottic opening(POGO)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Measurements of parameters related with physical examinations for difficult airway predictionOther
| Study group | Role | What they receive |
|---|---|---|
| Preoperative airway examination | patients undergoing general anesthesia for any surgery Receives: Other: Measurements of parameters related with physical examinations for difficult airway prediction |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of glottic opening (POGO)
POGO image will be captured using attachable fiberoptic scope.
Measured: During laryngoscopy manipulation for endotracheal intubation (average 3min after muscle relaxant is delivered)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Nov 2012 (estimated)
- Study startAug 2012
- Primary completionJul 2013
- Study completionJul 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Difficult LaryngoscopyStudies of the same condition, open and under way.
- More trials run by Samsung Medical CenterThe 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Samsung Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jong Hwan Lee, Samsung Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01719848
- Sponsor's protocol ID
- 2012-05-079-001
- Status last verified
- Apr 2014
- First submitted
- 29 Oct 2012
- Last updated
- 17 Apr 2014
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Min JJ, Kim G, Kim E, Lee JH. The diagnostic validity of clinical airway assessments for predicting difficult laryngoscopy using a grey zone approach. J Int Med Res. 2016 Aug;44(4):893-904. doi: 10.1177/0300060516642647. Epub 2016 Jun 6.
PubMed 27268499
Study at a glance
From the registry record, last updated by the sponsor on 17 Apr 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Clinical Airway Assessments for Predicting Difficult Laryngoscopy Using a Gray Zone Approach
- ClinicalTrials.gov ID
- NCT01719848
- Acronym / sponsor ID
- 2012-05-079-001
- Conditions
- Difficult Laryngoscopy
- Keywords
- Physical examinations, Percentage of glottic opening(POGO)
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Samsung Medical CenterUniversity, hospital or other
- Study start
- Aug 2012
- Primary completion
- Jul 2013 (actual)
- Study completion
- Jul 2013 (actual)
- First posted
- 1 Nov 2012 (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.
Failure of advanced airway security has been reported that it could lead lethal complication such as brain hypoxic damage. There have been controversial reports for the airway assessment tests which can predict difficult laryngoscopy. Therefore, we evaluated diagnostic validity of pre-existing airway assessment tests and scoring system using a gray zone approach in patients undergoing general anesthesia required endotracheal intubation.
Detailed description
POGO(percentage of glottic opening)will be evaluated by an attachable fiberoptic scope (AV scope. CAREtec CO.Ltd, Kangwon-Do, South Korea)
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Preoperative airway examination | – | Other: Measurements of parameters related with physical examinations for difficult airway predictionpatients undergoing general anesthesia for any surgery |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients undergoing general anesthesia for any surgery at Samsung medical center
Key inclusion criteria (1 listed)
- 20 to 80 years old patients undergoing general anesthesia for any operation.
Key exclusion criteria (5 listed)
- previous difficult airway history
- upper airway obstruction disease
- congenital disorders that are known to relate with difficult airway
- neurologic symptom associated with neck extension
- emergent operation
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 |
|---|---|---|
| Measurements of parameters related with physical examinations for difficult airway prediction | Other | Preoperative airway examination |
Primary outcome
Percentage of glottic opening (POGO)
Time frame: During laryngoscopy manipulation for endotracheal intubation (average 3min after muscle relaxant is delivered)
POGO image will be captured using attachable fiberoptic scope.
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 17 Apr 2014.
- Derived from this study: PubMed 27268499Min JJ, Kim G, Kim E, Lee JH. The diagnostic validity of clinical airway assessments for predicting difficult laryngoscopy using a grey zone approach. J Int Med Res. 2016 Aug;44(4):893-904. doi: 10.1177/0300060516642647. Epub 2016 Jun 6.
Related trials for Difficult Laryngoscopy
Not yet recruitingObservational study
Sniffing Position vs Left Head Rotation (LeHeR) Maneuver for Glottic View During Direct Laryngoscopy
Difficult Intubation, Laryngoscopy
Not yet recruitingObservational study
LeHeR Maneuver vs Sniffing Position During Video Laryngoscopy in Predicted Difficult Airway
Difficult Airway, Difficult Intubation
Not yet recruitingObservational study
Modified El-Ganzouri Risk Index for Predicting Difficult Intubation in Obese Patients
Difficult Intubation, Obesity
Not yet recruitingObservational study
Correlation Between Bedside Anatomical Indicators and Lifting Force and Glottic Exposure Under Different Video Laryngoscopy Techniques
Difficult Airway, Intubation, Intratracheal
Recruiting
Video Versus Direct Laryngoscopy for Tracheal Intubation in Pediatric Surgery
Tracheal Intubation, Videolaryngoscopy
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 Difficult Laryngoscopy, run by Samsung Medical Center at 1 site in South Korea.
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 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 17 Apr 2014. 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 South Korea. 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?
Percentage of glottic opening (POGO) (time frame: During laryngoscopy manipulation for endotracheal intubation (average 3min after muscle relaxant is delivered)). 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 NCT01719848, which also lists 1 linked publication.
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 17 Apr 2014.