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

NCT01488370 | Completed Results

• 1 other identifier: 5110244
• Study Type: interventional
• Target: 65
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Endotracheal Intubation

Keywords

breathing tube placement

Outcome Measures

Primary Outcomes (1)

• 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.

  Less than one day, representing the day of surgery and period of endotracheal intubation during induction of general anesthesia

Secondary Outcomes (4)

• Successful Intubation After One Laryngoscopy Attempt

  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

  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

  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

  Through endotracheal intubation during induction of general anesthesia, an average of 10 minutes

Study Arms (3)

Glidescope

ACTIVE COMPARATOR

A device for endotracheal intubation.

Device: Endotracheal intubation

Storz

ACTIVE COMPARATOR

A device for endotracheal intubation.

Device: Endotracheal intubation

Standard Laryngoscope

ACTIVE COMPARATOR

A device for endotracheal intubation

Device: Endotracheal intubation

Interventions

Endotracheal intubation DEVICE

Endotracheal intubation

Also known as: Storz DCI video laryngoscope, Glidescope video laryngoscope

Glidescope; Standard Laryngoscope; Storz

Eligibility Criteria

• Age: Up to 23 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Loma Linda University: lead

Study Sites (2)

Loma Linda University Department of Anesthesiology

Loma Linda, California, 92354, United States

Location

Loma Linda University Medical Center

Loma Linda, California, 92354, United States

Location

MeSH Terms

Interventions

Intubation, Intratracheal

Intervention Hierarchy (Ancestors)

Airway Management; Therapeutics; Intubation; Investigative Techniques

Limitations and Caveats

Trainees reported more prior intubation experience using DL than the other laryngoscopes, so we were unable to equalize prior clinical experience between DL \& other laryngoscopes. Assessment of learning effect limited by intubation types within study

Results Point of Contact

• Title: Elizabeth Ghazal, MD
• Organization: Loma Linda University Department of Anesthesiology

EGhazal@llu.edu

909-558-4475

Study Officials

• Elizabeth Ghazal, MD

  Loma Linda University Department of Anesthesiology

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: November 1, 2011
• First Posted: December 8, 2011
• Study Start: November 1, 2011
• Primary Completion: July 1, 2015
• Study Completion: July 1, 2015
• Last Updated: March 26, 2019
• Results First Posted: May 18, 2017

Record last verified: 2019-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)