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

Not Applicable

Completed

• Conditions: Endotracheal Intubation
• Interventions: Device: Endotracheal intubation

• Registration Number: NCT01488370
• Lead Sponsor: Loma Linda University

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-11
• Study First Submitted: 2011-11-01
• Study First Submitted QC: 2011-12-06
• Study First Posted: 2011-12-08
• Primary Completion: 2015-07
• Study Completion: 2015-07
• Results First Submitted: 2016-12-08
• Results First Submitted QC: 2017-04-14
• Results First Posted: 2017-05-18
• Status Verified: 2019-03
• Last Update Submitted: 2019-03-12
• Last Update Posted: 2019-03-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 65

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Standard Laryngoscope	Endotracheal intubation	A device for endotracheal intubation
Glidescope	Endotracheal intubation	A device for endotracheal intubation.
Storz	Endotracheal intubation	A device for endotracheal intubation.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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 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 One Laryngoscopy Attempt	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.
Successful Intubation After Four Laryngoscopy Attempts	Through endotracheal intubation during induction of general anesthesia, an average of 10 minutes

Trial Locations

Locations (2)

Loma Linda University Department of Anesthesiology; 🇺🇸 Loma Linda, California, United States

Loma Linda University Medical Center; 🇺🇸 Loma Linda, California, United States