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Comparing Use of the Glidescope Cobalt to Direct Laryngoscopy in Infants

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ClinicalTrials.gov Identifier: NCT01163656
Recruitment Status : Completed
First Posted : July 16, 2010
Results First Posted : January 18, 2013
Last Update Posted : January 31, 2013
Sponsor:
Information provided by (Responsible Party):
Children's Hospital of Philadelphia

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Intubation
Interventions Device: Miller Laryngoscope
Device: Glidescope Cobalt Video Laryngoscopes
Enrollment 66
Recruitment Details Healthy infants under the age of 12 months undergoing elective surgery requiring tracheal intubation were eligible.
Pre-assignment Details Any subject was excluded from participation if they were known or suspected to be a difficult intubation or if they required a rapid-sequence intubation.
Arm/Group Title Direct Laryngoscopy Approach Glidescope Videoscope Approach
Hide Arm/Group Description Subjects were randomly assigned to an arm. Subjects were randomly assigned to an arm.
Period Title: Overall Study
Started 33 33
Completed 30 30
Not Completed 3 3
Arm/Group Title Direct Laryngoscopy Approach Glidescope Videoscope Approach Total
Hide Arm/Group Description Subjects were randomly assigned to an arm. Subjects were randomly assigned to an arm. Total of all reporting groups
Overall Number of Baseline Participants 33 33 66
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 33 participants 33 participants 66 participants
<=18 years
33
 100.0%
33
 100.0%
66
 100.0%
Between 18 and 65 years
0
   0.0%
0
   0.0%
0
   0.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 33 participants 33 participants 66 participants
0.425  (0.275) 0.492  (0.283) 0.459  (0.279)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 33 participants 33 participants 66 participants
Female
13
  39.4%
5
  15.2%
18
  27.3%
Male
20
  60.6%
28
  84.8%
48
  72.7%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 33 participants 33 participants 66 participants
33 33 66
1.Primary Outcome
Title Time to Tracheal Intubation
Hide Description The amount of time it takes the anesthesiologist to insert a breathing tube using one of two methods, either by direct laryngoscopy or using the Glidescope Cobalt Video system.
Time Frame Measured the time of the randomized device past the teeth/gums until its removal after intubation as the time to intubation.
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Direct Laryngoscopy Approach Glidescope Videoscope Approach
Hide Arm/Group Description:
Subjects were randomly assigned to an arm.
Subjects were randomly assigned to an arm.
Overall Number of Participants Analyzed 30 30
Median (95% Confidence Interval)
Unit of Measure: seconds
21.4
(9.5 to 66.1)
22.6
(13.3 to 61.0)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Direct Laryngoscopy Approach Glidescope Videoscope Approach
Hide Arm/Group Description Subjects were randomly assigned to an arm. Subjects were randomly assigned to an arm.
All-Cause Mortality
Direct Laryngoscopy Approach Glidescope Videoscope Approach
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Direct Laryngoscopy Approach Glidescope Videoscope Approach
Affected / at Risk (%) Affected / at Risk (%)
Total   0/0   0/0 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Direct Laryngoscopy Approach Glidescope Videoscope Approach
Affected / at Risk (%) Affected / at Risk (%)
Total   0/0   0/0 
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: John Fiadjoe, MD
Organization: The Children's Hospital of Philadelphia
Phone: 215-590-3916
EMail: fiadjoej@email.chop.edu
Layout table for additonal information
Responsible Party: Children's Hospital of Philadelphia
ClinicalTrials.gov Identifier: NCT01163656     History of Changes
Other Study ID Numbers: 10-007533
First Submitted: July 13, 2010
First Posted: July 16, 2010
Results First Submitted: December 13, 2012
Results First Posted: January 18, 2013
Last Update Posted: January 31, 2013