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Glidescope Videolaryngoscope and Macintosh Laryngoscope in Children

Sponsor
Sisli Hamidiye Etfal Training and Research Hospital (Other)
Overall Status
Completed
CT.gov ID
NCT03326882
Collaborator
(none)
80
Enrollment
2
Arms
2
Duration (Months)

Study Details

Study Description

Brief Summary

The main objective of this study was to evaluate the intubation time of Glidescope compared with Macintoch laryngoscope in pediatric patients, ease of intubation, and cardiovascular changes during intubation.

Condition or Disease Intervention/Treatment Phase
  • Device: Endotracheal intubation
 N/A

Detailed Description

This was a prospective randomized clinical study to be performed in pediatric patients older than 1 years who are undergoing surgical procedures requiring endotracheal intubation. Time to endotracheal intubation was compared between patients intubated using a GlideScope® video laryngoscope, and those intubated by standard direct laryngoscopy. The main objective of this study was to evaluate the intubation time of Glidescope compared with Macintoch laryngoscope in pediatric patients, ease of intubation, and cardiovascular changes during intubation.

Study Design

Study Type:
Interventional
Actual Enrollment :
80 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Outcomes Assessor)
Primary Purpose:
Other
Official Title:
Comparison of Glidescope Videolaryngoscope and Macintosh Laryngoscope in Children Aged >1 Years
Study Start Date :
Feb 1, 2016
Actual Primary Completion Date :
Mar 1, 2016
Actual Study Completion Date :
Apr 1, 2016

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Glidescope

A device for endotracheal intubation

Device: Endotracheal intubation
Other Names:
  • Glidescope video laryngoscope

    		•
    Active Comparator: Macintosh laringoscope

    A device for endotracheal intubation

    Device: Endotracheal intubation
    Other Names:
  • Glidescope video laryngoscope

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Duration of Intubation [Intraoperative]

      Time from laryngoscopy to intubation

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    1 Year to 12 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:

    • ASA physical status I-II patients,

    • scheduled for elective surgery under general anesthesia with endotracheal intubation

    Exclusion Criteria:

    • risk of pulmonary aspiration,

    • presence of difficult intubation,

    • emergency surgery,

    • cardiovascular disease,

    • respiratuar disease,

    • hemodynamic instability.

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Sisli Hamidiye Etfal Training and Research Hospital

    Investigators

    • Study Director: Canan Tulay Isil, Sisli Hamidiye Etfal Training and Research Hospital

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    Canan Tulay ISIL, M.D., Sisli Hamidiye Etfal Training and Research Hospital
    ClinicalTrials.gov Identifier:
    NCT03326882
    Other Study ID Numbers:
    • SEEAH
    First Posted:
    Oct 31, 2017
    Last Update Posted:
    Oct 31, 2017
    Last Verified:
    Oct 1, 2017
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No

    Study Results

    No Results Posted as of Oct 31, 2017