NCT03326882

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Feb 2016

Shorter than P25 for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2016

Completed
29 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2016

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2016

Completed
1.6 years until next milestone

First Submitted

Initial submission to the registry

October 24, 2017

Completed
7 days until next milestone

First Posted

Study publicly available on registry

October 31, 2017

Completed
Last Updated

October 31, 2017

Status Verified

October 1, 2017

Enrollment Period

29 days

First QC Date

October 24, 2017

Last Update Submit

October 30, 2017

Conditions

AnesthesiologyPediatrics

Outcome Measures

Primary Outcomes (1)

  • Duration of Intubation

    Time from laryngoscopy to intubation

    Intraoperative

Study Arms (2)

Glidescope

ACTIVE COMPARATOR

A device for endotracheal intubation

Device: Endotracheal intubation

Macintosh laringoscope

ACTIVE COMPARATOR

A device for endotracheal intubation

Device: Endotracheal intubation

Interventions

Endotracheal intubationDEVICE
Also known as: Glidescope video laryngoscope
GlidescopeMacintosh laringoscope

Eligibility Criteria

Age1 Year - 12 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • ASA physical status I-II patients,
  • scheduled for elective surgery under general anesthesia with endotracheal intubation

You may not qualify if:

  • risk of pulmonary aspiration,
  • presence of difficult intubation,
  • emergency surgery,
  • cardiovascular disease,
  • respiratuar disease,
  • hemodynamic instability.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Holm-Knudsen RJ, Rasmussen LS. Paediatric airway management: basic aspects. Acta Anaesthesiol Scand. 2009 Jan;53(1):1-9. doi: 10.1111/j.1399-6576.2008.01794.x.

    PMID: 19128325BACKGROUND

MeSH Terms

Interventions

Intubation, Intratracheal

Intervention Hierarchy (Ancestors)

Airway ManagementTherapeuticsIntubationInvestigative Techniques

Study Officials

  • Canan Tulay Isil

    Sisli Hamidiye Etfal Training and Research Hospital

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
M.D.

Study Record Dates

First Submitted

October 24, 2017

First Posted

October 31, 2017

Study Start

February 1, 2016

Primary Completion

March 1, 2016

Study Completion

April 1, 2016

Last Updated

October 31, 2017

Record last verified: 2017-10

Data Sharing

IPD Sharing
Will not share

This kind of data can only be shared with additional governemental agreement.