Comparison of 2 Laryngoscopes for Endotracheal Intubation in Children Younger Than 2 Years Old

March 12, 2019 updated by: Elizabeth Ghazal, Loma Linda University

A Comparison of the Glidescope® Video Laryngoscope and the Storz DCI® Video Laryngoscope for Endotracheal Intubation in Children Younger Than Two Years of Age

This is a prospective randomized clinical study to be performed in pediatric patients under the age of 2 years who are undergoing surgical procedures requiring endotracheal intubation. Time to endotracheal intubation will be compared between patients intubated using a GlideScope® video laryngoscope, those intubated with a Storz DCI® video laryngoscope, and those intubated by standard direct laryngoscopy. The study hypothesis is that the time to endotracheal intubation will be decreased in the Storz DCI® video laryngoscope group when compared to the GlideScope® video laryngoscope group and standard laryngoscopy.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

65

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Loma Linda, California, United States, 92354
        • Loma Linda University Medical Center
      • Loma Linda, California, United States, 92354
        • Loma Linda University Department of Anesthesiology

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 1 year (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Pediatric patients under the age of 2 years undergoing surgeries requiring endotracheal intubation at LLUMC will be eligible for participation in this study

Exclusion Criteria:

  • Children with increased pulmonary aspiration risk;
  • Prior documentation of difficult endotracheal intubation;
  • Those that lack legal representative consent

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Glidescope
A device for endotracheal intubation.
Device: Endotracheal intubation
Endotracheal intubation
Other Names:
  • Glidescope video laryngoscope
  • Storz DCI video laryngoscope
Active Comparator: Storz
A device for endotracheal intubation.
Device: Endotracheal intubation
Endotracheal intubation
Other Names:
  • Glidescope video laryngoscope
  • Storz DCI video laryngoscope
Active Comparator: Standard Laryngoscope
A device for endotracheal intubation
Device: Endotracheal intubation
Endotracheal intubation
Other Names:
  • Glidescope video laryngoscope
  • Storz DCI video laryngoscope

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Measurement of Time to Intubation Will Begin at the Time of Mouth Opening and End With the Removal of the Tip of the Laryngoscope Blade From the Patient's Mouth After Successful Endotracheal Intubation.
Time Frame: Less than one day, representing the day of surgery and period of endotracheal intubation during induction of general anesthesia
Less than one day, representing the day of surgery and period of endotracheal intubation during induction of general anesthesia

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Successful Intubation After One Laryngoscopy Attempt
Time Frame: Less than one day, representing the day of surgery and period of endotracheal intubation during induction of general anesthesia.
Other secondary outcome measures will be the use of external laryngeal manipulation to improve glottic view, tissue trauma and type,and method of rescue if initial intubation attempt proves unsuccessful.
Less than one day, representing the day of surgery and period of endotracheal intubation during induction of general anesthesia.
Successful Intubation After Two Laryngoscopy Attempts
Time Frame: Less than one day, representing the day of surgery and period of endotracheal intubation during induction of general anesthesia.
Less than one day, representing the day of surgery and period of endotracheal intubation during induction of general anesthesia.
Successful Intubation After Three Laryngoscopy Attempts
Time Frame: Less than one day, representing the day of surgery and period of endotracheal intubation during induction of general anesthesia.
Less than one day, representing the day of surgery and period of endotracheal intubation during induction of general anesthesia.
Successful Intubation After Four Laryngoscopy Attempts
Time Frame: Through endotracheal intubation during induction of general anesthesia, an average of 10 minutes
Through endotracheal intubation during induction of general anesthesia, an average of 10 minutes

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Loma Linda University

Investigators

  • Principal Investigator: Elizabeth Ghazal, MD, Loma Linda University Department of Anesthesiology

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2011

Primary Completion (Actual)

July 1, 2015

Study Completion (Actual)

July 1, 2015

Study Registration Dates

First Submitted

November 1, 2011

First Submitted That Met QC Criteria

December 6, 2011

First Posted (Estimate)

December 8, 2011

Study Record Updates

Last Update Posted (Actual)

March 26, 2019

Last Update Submitted That Met QC Criteria

March 12, 2019

Last Verified

March 1, 2019

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 5110244

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Endotracheal Intubation

Clinical Trials on Endotracheal intubation

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Bulgaria

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe