Comparison of VivaSightTM Double Lumen Tube With a Conventional Double Lumen Tube

Phase 4

Completed

• Conditions: Airway Management; Endotracheal Intubation; One Lung Ventilation
• Interventions: Device: VivaSight double lumen tube; Device: Standard double lumen tube

• Registration Number: NCT02253979
• Lead Sponsor: Rambam Health Care Campus

Brief Summary

Double lumen tube (DLT) is an enotracheal tube that facilitates one lung ventilation. The DLT exact position in the airways is verified by fiber-optic bronchoscopy (FOB) after intubation. The VivaSight TM DL is a single use left DLT with a camera embedded in the tube's right side port. This study was designed to compare the VivaSightTM DL to the standard DLT.

Detailed Description

Double lumen tube (DLT) is an enotracheal tube that facilitates one lung ventilation. The efficiency of the DLT depends on its exact position in the airways, as verified by fiber-optic bronchoscopy (FOB) after intubation, and re-verified after positioning the patient on the lateral position. The VivaSight TM DL is a single use left DLT with a camera embedded in the tube's right side port. The view from the camera appears continuously on a monitor. This study was designed to compare the VivaSightTM DL to the standard DLT. The primary end point is the time required for intubation with visual confirmation of DLT position.

Study Timeline

• Study Start: 2013-01
• Primary Completion: 2014-07
• Study Completion: 2014-07
• Status Verified: 2014-09
• Study First Submitted: 2014-09-28
• Study First Submitted QC: 2014-09-30
• Last Update Submitted: 2014-09-30
• Study First Posted: 2014-10-01
• Last Update Posted: 2014-10-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 71

Inclusion Criteria

• adult patients undergoing video assisted thoracoscopic lung lobectomy

Exclusion Criteria

• anticipated difficult intubation, patients who required rapid sequence induction
• patients with known tracheal pathology

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
VivaSight double lumen tube	VivaSight double lumen tube	Intervention: VivaSight double lumen tube
standard double lumen tube	Standard double lumen tube	Intervention: Standard double lumen tube

Primary Outcome Measures

Name	Time	Method
Time required for endotracheal intubation with visual confirmation of double lumen tube position position.	During induction of general anesthesia