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Predictors of Difficult Videolaryngoscopy

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ClinicalTrials.gov Identifier: NCT03495596
Recruitment Status : Unknown
Verified April 2018 by Sevilay Kivrakoglu, Hacettepe University.
Recruitment status was:  Recruiting
First Posted : April 12, 2018
Last Update Posted : April 24, 2018
Sponsor:
Information provided by (Responsible Party):
Sevilay Kivrakoglu, Hacettepe University

Tracking Information
First Submitted Date April 5, 2018
First Posted Date April 12, 2018
Last Update Posted Date April 24, 2018
Actual Study Start Date January 17, 2018
Estimated Primary Completion Date June 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: April 5, 2018)
Intubation success [ Time Frame: 15 minutes ]
The success of intubation attempt with videolaryngoscopy (yes/no)
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: April 5, 2018)
  • The reason of videolaryngoscopy [ Time Frame: 15 minutes ]
    Why videolaryngoscopy is preferred instead of standard direct laryngoscopy
  • The type of videolaryngoscopy blade [ Time Frame: 15 minutes ]
    acute angled/macintosh/miller blade
  • The rescue technique [ Time Frame: 30 minutes ]
    The rescue technique used for patients who could not be intubated with videolaryngoscopy
  • Factors affecting success of videolaryngoscopy [ Time Frame: 30 minutes ]
    Mallampati, thyromental distance, neck movements, upper lip bite test, mouth opening
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Predictors of Difficult Videolaryngoscopy
Official Title Determining the Parameters Affecting the Failure of Videolaryngoscopy
Brief Summary The primary goal of this study was to identify parameters affecting the failure of videolaryngoscopy in clinical practice; secondly, the incidence of videolaryngoscopy use and the most frequently used patient groups.
Detailed Description Videolaryngoscopy is widely used in the management of patients with presumed difficult airway. It offers an improved laryngeal view compared with direct laryngoscopy and increases the likelihood of successful intubation in patients for whom direct laryngoscopy is anticipated to be difficult. It is among the most frequently preferred difficult airway devices due to its ease of use, portability and direct laryngoscopy resemblance. The use of videolaryngoscopy has been shown to improve intubation success in many cases associated with difficult intubation, such as morbid obesity, pregnancy, limitation of cervical motility, and poor mouth opening.
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Cross-Sectional
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Patients who will undergo surgery under general anesthesia will be followed in Hacettepe University Hospital's operating room. All patients aged 0-95 years who used videolaryngoscopy will be included in the study.
Condition Videolaryngoscopy
Intervention Device: Videolaryngoscopy
Videolaryngoscopy device type
Study Groups/Cohorts Videolaryngoscopy patients
The patients who were attempted to be intubated with videolaryngoscopy
Intervention: Device: Videolaryngoscopy
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Unknown status
Estimated Enrollment
 (submitted: April 5, 2018)
2000
Original Estimated Enrollment Same as current
Estimated Study Completion Date October 2020
Estimated Primary Completion Date June 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • All patients who used videolaryngoscopy for intubation

Exclusion Criteria:

-

Sex/Gender
Sexes Eligible for Study: All
Ages up to 95 Years   (Child, Adult, Older Adult)
Accepts Healthy Volunteers Not Provided
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Turkey
Removed Location Countries  
 
Administrative Information
NCT Number NCT03495596
Other Study ID Numbers Videolaryngoscopy
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement Not Provided
Responsible Party Sevilay Kivrakoglu, Hacettepe University
Study Sponsor Hacettepe University
Collaborators Not Provided
Investigators
Study Director: Aysun Ankay Yilbas, MD Turkish Society of Anesthesiology and Reanimation
Principal Investigator: Sevilay Kivrakoglu, MD Turkish Society of Anesthesiology and Reanimation
PRS Account Hacettepe University
Verification Date April 2018