Comparison of the VividTrac® Videolaryngoscope to Direct Laryngoscopy in Adults Under Manual Inline Stabilization

Endotracheal Intubation Clinical Trial

Official title:

Comparison of the VividTrac® Videolaryngoscope to Direct Laryngoscopy in Adults Under Manual Inline Stabilization

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT02479672
• Other study ID #: 5150229
• Status: Withdrawn
• Phase: N/A
• First received: June 17, 2015
• Last updated: October 10, 2016
• Start date: January 2016
• Est. completion date: July 2016

Study information

• Verified date: October 2016
• Source: Loma Linda University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

This is a prospective randomized clinical study to be performed in adult patients ages 18 and older who are undergoing surgical procedures requiring endotracheal intubation. Adult patients will be randomized to either the VideoTrac® laryngoscope or direct laryngoscopy and the time to intubation will be compared and recorded. Patients in both treatment arms will receive manual inline stabilization. The study hypothesis is that the time to endotracheal intubation will be decreased in the VividTrac® video laryngoscope group when compared to direct laryngoscopy.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: July 2016
• Est. primary completion date: July 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patients will be 18 years old and older requiring endotracheal intubation

Exclusion Criteria:

• Patients with increased pulmonary risk;

• Prior documentation of difficult endotracheal intubation;

• elevated intracranial pressure;

• those who lack legal representative consent

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Endotracheal Intubation

Intervention

Device:
• laryngoscopy
Placement of endotracheal tube. If successful intubation does not occur after the first attempt at laryngoscopy, airway equipment used in further attempts will be selected at the discretion of the attending anesthesiologist.

Procedure:
• Manual Inline Stabilization
Manual immobilization of Patient's neck with intention to minimize movement from baseline position

Device:
• VividTrac®

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Loma Linda University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time to Intubation	Time frame being assessed will begin at the time of mouth opening and end with the removal of the tip of laryngoscope blade from the patient's mouth after successful endotracheal intubation.	day of surgery	No