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

NCT ID: NCT01488370

Last Updated: 2019-03-26

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

65 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-11-30

Study Completion Date

2015-07-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Endotracheal Intubation

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Glidescope

A device for endotracheal intubation.

Group Type ACTIVE_COMPARATOR

Endotracheal intubation

Intervention Type DEVICE

Endotracheal intubation

Storz

A device for endotracheal intubation.

Group Type ACTIVE_COMPARATOR

Endotracheal intubation

Intervention Type DEVICE

Endotracheal intubation

Standard Laryngoscope

A device for endotracheal intubation

Group Type ACTIVE_COMPARATOR

Endotracheal intubation

Intervention Type DEVICE

Endotracheal intubation

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Endotracheal intubation

Endotracheal intubation

Intervention Type DEVICE

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Storz DCI video laryngoscope Glidescope video laryngoscope

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Maximum Eligible Age

23 Months

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Loma Linda University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Elizabeth Ghazal

MD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Elizabeth Ghazal, MD

Role: PRINCIPAL_INVESTIGATOR

Loma Linda University Department of Anesthesiology

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Loma Linda University Department of Anesthesiology

Loma Linda, California, United States

Site Status

Loma Linda University Medical Center

Loma Linda, California, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

5110244

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Pediatric Intubation
NCT02289872 COMPLETED NA