Try our beta test site
IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more...

GlideScope Video Laryngoscope Versus Fiberoptic Intubation

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
The Cleveland Clinic
ClinicalTrials.gov Identifier:
NCT01091948
First received: March 9, 2010
Last updated: October 26, 2016
Last verified: October 2016

March 9, 2010
October 26, 2016
February 2008
June 2009   (Final data collection date for primary outcome measure)
Time to Intubation (TTI) as Measured in Seconds [ Time Frame: from start of intubation to successfully intubated up to 100 seconds ]
Time from insertion of either the GlideScope or in the case of fibreoptic intubation, a Williams airway (SunMed, Largo, FL, USA) into the mouth, to the time when end-tidal PCO2 exceeded 2.7 kPa (20 mmHg).
Time to Intubation (TTI) as Measured in Seconds [ Time Frame: seconds ]
Complete list of historical versions of study NCT01091948 on ClinicalTrials.gov Archive Site
  • Intubation Difficulty Score [ Time Frame: from start of intubation to successfully intubated ]
    Intubation difficulty score is a 100-mm-long visual analogue scale (100 mm = extremely difficult);
  • Successful Intubation on 1st Attempt [ Time Frame: from start of first intubation to end of first intubation attempt ]
  • Occurrence of Hypoxaemia [ Time Frame: at 1 min prior to intubation, intubation, and 2, 4, 6, 8, and 10 min after ]
    Arterial oxygen saturation was recorded at 1 min prior to intubation, intubation, and 2, 4, 6, 8, and 10 min after; hypoxaemia was defined as occurrence of arterial oxygen saturation <90% at any of the above measurements.
  • Trace Bleeding [ Time Frame: Right after intubation ]
    Trace bleeding is a binary outcome: yes or no, which is determined based on amount of post-intubation bleeding present in the suction tube
  • Sore Throat Grade [ Time Frame: On the first postoperative day ]
  • Number of Intubation Attempts [ Time Frame: from start of intubation to successfully intubated ]
Ease of intubation [ Time Frame: seconds ]
Secondary outcomes will include ease of intubation (as recorded by the operator immediately after intubation on a 100 mm visual analog scale [VAS]),the glottic view, whether or not optimization maneuvers were used or not, the number of failures, the number of attempts made, and the amount of bleeding that occurred.
Not Provided
Not Provided
 
GlideScope Video Laryngoscope Versus Fiberoptic Intubation
GlideScope Video Laryngoscope vs Fiberoptic Intubation
Following informed consent, patients will be randomly assigned to oral fiberoptic intubation or to oral intubation using the GlideScope Video Laryngoscope. Following the induction of general anesthesia a sealed envelope would be opened to reveal the technique to be used. A stop watch will be started at the beginning of the procedure. At the completion of intubation the stop watch will be stopped and the time recorded along with other data. Based on a sample size estimation process, it is the investigators plan to study fifty patients. The two techniques will be compared in terms of the average time needed to place the endotracheal tube and studied using a two-sided T-Test with a significance level of 0.05. To ensure comparability between the two methods, all intubators will be required to have at experienced at least 10 uses of the GlideScope and 10 uses with fiberoptic intubation.
Not Provided
Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Participant)
Primary Purpose: Supportive Care
Oral Intubation
  • Device: Intubation with Fiberoptic laryngoscope
    Subjects will be intubated with the Fiberoptic laryngoscope.
    Other Names:
    • Fiberoptic
    • laryngoscope
  • Device: GlideScope® Video Laryngoscope
    Patients will be intubated with the GlideScope® Video Laryngoscope.
    Other Names:
    • GlideScope®
    • Video Laryngoscope
  • Active Comparator: Fiberoptic Intubation
    Subjects will be intubated with the Fiberoptic laryngoscope.
    Intervention: Device: Intubation with Fiberoptic laryngoscope
  • Active Comparator: GlideScope® Video Laryngoscope
    Subjects will be intubated with the GlideScope® Video Laryngoscope.
    Intervention: Device: GlideScope® Video Laryngoscope
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
75
January 2010
June 2009   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • at least 18 years old
  • scheduled for elective surgery requiring orotracheal intubation.

Exclusion Criteria:

  • known, difficult airway
  • loose teeth
  • pregnant
  • require a rapid sequence induction,
  • Body Mass Index under 30
  • unable to give consent
  • if special endotracheal tube (ETT) is needed for the case.
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT01091948
08-079
No
Not Provided
Not Provided
Not Provided
The Cleveland Clinic
The Cleveland Clinic
Not Provided
Study Chair: Daniel I Sessler, MD The Cleveland Clinic
The Cleveland Clinic
October 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP