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

NCT02479672 — Not applicable, Withdrawn, Loma Linda University
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RegistryNCT02479672
StatusWithdrawn - This study was never started.
PhaseNot applicable
Study typeInterventional; randomized, parallel, masking: single, diagnostic
SponsorLoma Linda University (Other)
ConditionsEndotracheal Intubation
Interventionslaryngoscopy, Manual Inline Stabilization, VividTrac® (Device, procedure)
Datesstart 2016-01-01, primary completion 2016-07-01 (estimated), completion 2016-07-01 (estimated), first posted 2015-06-24, last updated 2016-10-12

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-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.

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+Arms and interventions

ArmTypeInterventionsDescription
VividTrac video laryngoscopeActive comparatorProcedure: Manual Inline Stabilization; Device: VividTrac®VividTrac® Videolaryngoscope, A device for endotracheal intubation
Direct laryngoscopyActive comparatorDevice: laryngoscopy; Procedure: Manual Inline StabilizationDirect laryngoscopy, A device for endotracheal intubation
  • 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.
  • Manual Inline Stabilization (Procedure): Manual immobilization of Patient's neck with intention to minimize movement from baseline position
  • VividTrac® (Device)

+Outcome measures

Primary outcomes

  • Time to Intubation [day of surgery]: 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.

+Eligibility

Sex: All, ages: 18 Years to any

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

My Notes