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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
  Purpose
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.

Condition Intervention
Oral Intubation
Device: Intubation with Fiberoptic laryngoscope
Device: GlideScope® Video Laryngoscope

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Supportive Care
Official Title: GlideScope Video Laryngoscope vs Fiberoptic Intubation

Further study details as provided by The Cleveland Clinic:

Primary Outcome Measures:
  • 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).


Secondary Outcome Measures:
  • 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 ]

Enrollment: 75
Study Start Date: February 2008
Study Completion Date: January 2010
Primary Completion Date: June 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Fiberoptic Intubation
Subjects will be intubated with the Fiberoptic laryngoscope.
Device: Intubation with Fiberoptic laryngoscope
Subjects will be intubated with the Fiberoptic laryngoscope.
Other Names:
  • Fiberoptic
  • laryngoscope
Active Comparator: GlideScope® Video Laryngoscope
Subjects will be intubated with the GlideScope® Video Laryngoscope.
Device: GlideScope® Video Laryngoscope
Patients will be intubated with the GlideScope® Video Laryngoscope.
Other Names:
  • GlideScope®
  • Video Laryngoscope

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01091948

Locations
United States, Ohio
Cleveland Clinic Foundation
Cleveland, Ohio, United States, 44195
Sponsors and Collaborators
The Cleveland Clinic
Investigators
Study Chair: Daniel I Sessler, MD The Cleveland Clinic
  More Information

Responsible Party: The Cleveland Clinic
ClinicalTrials.gov Identifier: NCT01091948     History of Changes
Other Study ID Numbers: 08-079 
Study First Received: March 9, 2010
Results First Received: June 20, 2016
Last Updated: October 26, 2016

Keywords provided by The Cleveland Clinic:
elective general surgery
orotracheal intubation
Patients would be eligible for inclusion if they were at least 18 years old and scheduled for elective surgery requiring orotracheal intubation.

ClinicalTrials.gov processed this record on February 23, 2017