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Combination of Physical Examinations to Predict Difficult Airway

This study is currently recruiting participants.
Verified October 2012 by Samsung Medical Center
Sponsor:
Information provided by (Responsible Party):
Jong Hwan Lee, Samsung Medical Center
ClinicalTrials.gov Identifier:
NCT01719848
First received: October 29, 2012
Last updated: October 30, 2012
Last verified: October 2012
History of Changes
  Purpose

Failure of airway security during the anesthetic induction has been reported that it could lead lethal complication such as brain hypoxic damage. Knowing difficult airway in advance of the anesthetic induction is able to give chance to anesthesiologists to prepare helper and other instrument. A variety of physical examinations have been used to predict difficult airway. However, there is no definitely reliable single physical examination and combination of the tests has been documented to increase of predictability of difficult airway. Therefore, we hypothesize that combination of all kinds of physical examinations might provide excellent prediction of difficult airway.


Condition Intervention
Difficult Intubation
 Other: Measurements of parameters related with physical examinations for difficult airway prediction

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Prediction of Difficult Airway:Put Them All Together

Further study details as provided by Samsung Medical Center:

Primary Outcome Measures:
  • Percentage of glottic opening (POGO) [ Time Frame: During laryngoscopy manipulation for endotracheal intubation (average 3min after muscle relaxant is delivered) ] [ Designated as safety issue: Yes ]
    POGO image will be captured using attachable fiberoptic scope.


Secondary Outcome Measures:
  • Intubation difficult scale (IDS) [ Time Frame: immediately after the endotracheal intubation (within 5min after muscle relaxant is delivered) ] [ Designated as safety issue: Yes ]
    Just description of the process of the endotracheal intubation. IDS score is numerical sum of the following parameters; number of attempts, number of operators, number of alternative technique, glottic exposure, lifting force during laryngoscopy, external laryngeal pressure for optimal glottic exposure, position of vocal cords for intubation.


Other Outcome Measures:
  • Occurence rate of difficult airway [ Time Frame: immediately after the tracheal intubation (within 5 min after muscle relaxant is delivered) ] [ Designated as safety issue: Yes ]
    IDS score >5 defines intubation with moderate to major difficulty


Estimated Enrollment: 200
Study Start Date: August 2012
Estimated Study Completion Date: July 2013
Estimated Primary Completion Date: April 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Preoperative airway examination
patients undergoing general anesthesia for any surgery
 Other: Measurements of parameters related with physical examinations for difficult airway prediction

Detailed Description:

POGO(percentage of glottic opening)will be evaluated by an attachable fiberoptic scope (AV scope. CAREtec CO.Ltd, Kangwon-Do, South Korea)

  Eligibility

Ages Eligible for Study:   20 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Patients undergoing general anesthesia for any surgery at Samsung medical center

Criteria

Inclusion Criteria:

  • 20 to 80 years old patients undergoing general anesthesia for any operation.

Exclusion Criteria:

  • 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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01719848

Contacts
Contact: Jong Hwan Lee, MD,PhD 82234101928 jonghwanlee75@samsung.com

Locations
Korea, Republic of
Samsung medical center Recruiting
Seoul, Korea, Republic of, 715-310
Contact: Gahyun Kim, MD     82234101994     gahyun80.kim@samsung.com    
Sub-Investigator: Gahyun Kim, MD            
Principal Investigator: Jong Hwan Lee, MD, PhD            
Sponsors and Collaborators
Samsung Medical Center
  More Information

No publications provided

Responsible Party: Jong Hwan Lee, assistant professor, Samsung Medical Center
ClinicalTrials.gov Identifier: NCT01719848     History of Changes
Other Study ID Numbers: 2012-05-079-001
Study First Received: October 29, 2012
Last Updated: October 30, 2012
Health Authority: South Korea: Institutional Review Board

Keywords provided by Samsung Medical Center:
Physical examinations, Percentage of glottic opening(POGO)

ClinicalTrials.gov processed this record on May 19, 2013