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Comparison of GlideScope-Specific Rigid Stylet to Standard Malleable Stylet for GlideScope Intubation by Novice Operators

Comparison of GlideScope-Specific Rigid Stylet to Standard Malleable Stylet for GlideScope Intubation by Novice Operators

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00884754
Enrollment
60
Registered
2009-04-21
Start date
2009-03-31
Completion date
2009-11-30
Last updated
2011-01-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Airway

Brief summary

Patients presenting for elective surgery requiring tracheal intubation will be randomized to one of two different endotracheal tube (ETT) stylets. The intubation will be done with a GlideScope videolaryngoscope by a novice operator. The primary outcome is time to intubation.

Interventions

DEVICEGlideScope rigid stylet

Patients will be intubated either with a rigid stylet meant to be used with the GlideScope, or with a standard malleable stylet used with other modalities of intubation.

Sponsors

London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Masking
DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No

Inclusion criteria

* any adult patient scheduled for elective surgery. * ETT is indicated for the procedure in the opinion of the attending anesthesiologist. * any operator who has performed ≤ 10 GlideScope intubations.

Exclusion criteria

* any patient in whom the use of the GlideScope is contraindicated in the opinion of the attending anesthesiologist. * Patient with known cervical spine abnormalities. * any patients with known or probable difficult airways. (This rare occurrence is unlikely to be evenly distributed between the groups and could skew the data). * any patient requiring rapid sequence induction.

Design outcomes

Primary

MeasureTime frame
Time to Intubation (Seconds)30-150 seconds (anticipated)

Countries

Canada

Participant flow

Participants by arm

ArmCount
Rigid GlideScope Specific Stylet30
90º Curvature, Malleable Stylet30
Total60

Baseline characteristics

CharacteristicRigid GlideScope Specific Stylet90º Curvature, Malleable StyletTotal
Age Categorical
Over 18 years
30 participants30 participants60 participants
Sex: Female, Male
Female
15 Participants18 Participants33 Participants
Sex: Female, Male
Male
15 Participants12 Participants27 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
— / —— / —
other
Total, other adverse events
0 / 300 / 30
serious
Total, serious adverse events
0 / 300 / 30

Outcome results

Primary

Time to Intubation (Seconds)

Time frame: 30-150 seconds (anticipated)

ArmMeasureValue (MEDIAN)
Rigid GlideScope Specific StyletTime to Intubation (Seconds)60 seconds
90º Curvature, Malleable StyletTime to Intubation (Seconds)61 seconds

Source: ClinicalTrials.gov · Data processed: Mar 30, 2026