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

NCT02479672 | Withdrawn

• 1 other identifier: 5150229
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Endotracheal Intubation

Keywords

breathing tube placement; VideoTrac® laryngoscope; direct laryngoscopy

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

VividTrac video laryngoscope

ACTIVE COMPARATOR

VividTrac® Videolaryngoscope, A device for endotracheal intubation

Procedure: Manual Inline Stabilization; Device: VividTrac®

Direct laryngoscopy

ACTIVE COMPARATOR

Direct laryngoscopy, A device for endotracheal intubation

Device: laryngoscopy; Procedure: Manual Inline Stabilization

Interventions

laryngoscopy DEVICE

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.

Direct laryngoscopy

Manual Inline Stabilization PROCEDURE

Manual immobilization of Patient's neck with intention to minimize movement from baseline position

Direct laryngoscopy; VividTrac video laryngoscope

VividTrac® DEVICE

VividTrac video laryngoscope

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Patients with increased pulmonary risk;
• Prior documentation of difficult endotracheal intubation;
• elevated intracranial pressure;
• those who lack legal representative consent

Sponsors & Collaborators

• Loma Linda University: lead

MeSH Terms

Interventions

Laryngoscopy

Intervention Hierarchy (Ancestors)

Diagnostic Techniques, Respiratory System; Diagnostic Techniques and Procedures; Diagnosis; Endoscopy; Diagnostic Techniques, Surgical; Minimally Invasive Surgical Procedures; Surgical Procedures, Operative; Otorhinolaryngologic Surgical Procedures

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: June 17, 2015
• First Posted: June 24, 2015
• Study Start: January 1, 2016
• Primary Completion: July 1, 2016
• Study Completion: July 1, 2016
• Last Updated: October 12, 2016

Record last verified: 2016-10