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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02547064
Other study ID # GlideMStylet
Secondary ID
Status Completed
Phase N/A
First received September 1, 2015
Last updated June 7, 2017
Start date October 2015
Est. completion date January 2016

Study information

Verified date June 2017
Source Keimyung University Dongsan Medical Center
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The GlideScope® videolaryngoscope usually visualize glottis better than the conventional laryngoscope. Under the visualization of glottis by GlideScope®, the insertion of endotracheal tube, however, is challenging.

The goal of this study was to determine which of two stylet (70° vs 90°) was better, as determined by time to intubation.


Recruitment information / eligibility

Status Completed
Enrollment 162
Est. completion date January 2016
Est. primary completion date January 2016
Accepts healthy volunteers No
Gender All
Age group 18 Years to 80 Years
Eligibility Inclusion Criteria:

- Patients requiring endotracheal intubation for general anesthesia

Exclusion Criteria:

- Difficult airway

- Rapid sequence induction

- Recent sore throat

- Fragile teeth

- Contraindication for videolaryngoscope

- Head and neck surgery

Study Design


Related Conditions & MeSH terms


Intervention

Procedure:
Glidescope guided intubation

Device:
GlideScope®


Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Keimyung University Dongsan Medical Center

Outcome

Type Measure Description Time frame Safety issue
Primary Time to Intubation Time from the insertion of the Glidescope blade to the measurement of end tidal CO2 (>30 mmHg) Intraoperative intubation
Secondary Success Rate of Intubation The number of patients in which the intubation was successful at the first time. Intraoperative intubation
Secondary Difficulty of Intubation Measured Using Visual Analogue Scale Difficulty of intubation will be measured using visual analogue scale (0:easiest, 100:most difficult). Intraoperative intubation
Secondary Number of Participants for Whom External Laryngeal Manipulation Was Necessary External laryngeal manipulation is defined as the compression of neck for the facilitation of laryngeal view. Number of participants for whom external laryngeal manipulation was necessary will be measured. Intraoperative intubation
Secondary Cormack-Lehan Grade The grade of Cormack-Lehan was assessed as I/II/III/IV (I: Full view of glottis, II: Partial view of glottis, III: Only epiglottis seen, none of glottis seen, IV: Neither glottis nor epiglottis seen). Grade I was considered better outcomes. Intraoperative intubation
Secondary Mallampati Grade The Mallapati grade was assessed as I/II/III/IV (I: Soft palate, uvula, fauces, pillars visible, II: Soft palate, uvula, fauces visible, III: Soft palate, base of uvula visible, IV: Only hard palate visible). Grade I was considered better outcomes. Intraoperative anesthetic induction
Secondary Thyromental Distance The thyromental distance was measured. Intraoperative anesthetic induction
Secondary Postoperative Sore Throat Measured Using Visual Analogue Scale Postoperative sore throat will be measured using visual analogue scale (0:no pain, 100: worst pain imaginable) at 1, 24 hr postoperatively
Secondary Mean Blood Pressure Mean blood pressure is measured before and 2 min after intubation. Intraoperative intubation
Secondary Heart Rate Heart rates are measured before and 2 min after intubation. Intraoperative intubation
Secondary Airway Injury Larynx injury is assessed. Intraoperative intubation
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