GlideScope Video Laryngoscope Versus Fiberoptic Intubation

Oral Intubation Clinical Trial

Official title:

GlideScope Video Laryngoscope vs Fiberoptic Intubation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01091948
• Other study ID #: 08-079
• Status: Completed
• Phase: N/A
• First received: March 9, 2010
• Last updated: April 2, 2010
• Start date: February 2008
• Est. completion date: January 2010

Study information

• Verified date: March 2010
• Source: Outcomes Research Consortium
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 75
• Est. completion date: January 2010
• Est. primary completion date: June 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Oral Intubation

Intervention

Device:
• Intubation with Fiberoptic laryngoscope
Subjects will be intubated with the Fiberoptic laryngoscope.
• GlideScope® Video Laryngoscope
Patients will be intubated with the GlideScope® Video Laryngoscope.

Locations

Country	Name	City	State
United States	Cleveland Clinic Foundation	Cleveland	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
Outcomes Research Consortium

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	time to intubation (TTI) as measured in seconds		seconds	No
Secondary	Ease of intubation	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.	seconds	No