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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01488370
Other study ID # 5110244
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date November 2011
Est. completion date July 2015

Study information

Verified date March 2019
Source Loma Linda University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 65
Est. completion date July 2015
Est. primary completion date July 2015
Accepts healthy volunteers No
Gender All
Age group N/A to 23 Months
Eligibility 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


Related Conditions & MeSH terms


Intervention

Device:
Endotracheal intubation
Endotracheal intubation

Locations

Country Name City State
United States Loma Linda University Department of Anesthesiology Loma Linda California
United States Loma Linda University Medical Center Loma Linda California

Sponsors (1)

Lead Sponsor Collaborator
Loma Linda University

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 Successful Intubation After One Laryngoscopy Attempt 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.
Secondary 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.
Secondary 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.
Secondary Successful Intubation After Four Laryngoscopy Attempts Through endotracheal intubation during induction of general anesthesia, an average of 10 minutes
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