GlideScope Video Laryngoscope Versus Fiberoptic Intubation

Not Applicable

Completed

• Conditions: Oral Intubation
• Interventions: Device: Intubation with Fiberoptic laryngoscope; Device: GlideScope® Video Laryngoscope

• Registration Number: NCT01091948
• Lead Sponsor: The Cleveland Clinic

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-02
• Primary Completion: 2009-06
• Study Completion: 2010-01
• Study First Submitted: 2010-03-09
• Study First Submitted QC: 2010-03-23
• Study First Posted: 2010-03-24
• Results First Submitted: 2016-06-20
• Status Verified: 2016-10
• Results First Submitted QC: 2016-10-26
• Last Update Submitted: 2016-10-26
• Results First Posted: 2016-12-20
• Last Update Posted: 2016-12-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 75

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Fiberoptic Intubation	Intubation with Fiberoptic laryngoscope	Subjects will be intubated with the Fiberoptic laryngoscope.
GlideScope® Video Laryngoscope	GlideScope® Video Laryngoscope	Subjects will be intubated with the GlideScope® Video Laryngoscope.

Primary Outcome Measures

Name	Time	Method
Time to Intubation (TTI) as Measured in Seconds	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

Name	Time	Method
Intubation Difficulty Score	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	from start of first intubation to end of first intubation attempt
Occurrence of Hypoxaemia	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	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	On the first postoperative day
Number of Intubation Attempts	from start of intubation to successfully intubated

Trial Locations

Locations (1)

Cleveland Clinic Foundation; 🇺🇸 Cleveland, Ohio, United States