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

• Sponsor: Rambam Health Care Campus (Other)
• Overall Status: Completed
• CT.gov ID: NCT02253979
• Collaborator: (none)
• Enrollment: 71
• Arms: 2
• Duration (Months): 17.9

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Endotracheal Intubation; Airway Management; One Lung Ventilation	Device: Standard double lumen tube; Device: VivaSight double lumen tube	Phase 4

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 Design

• Study Type: Interventional
• Actual Enrollment: 71 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Comparison of VivaSightTM Double Lumen Tube With a Conventional Double Lumen Tube in Adult Patients Undergoing Video Assisted Thoracoscopic Surgery
• Study Start Date: Jan 1, 2013
• Actual Primary Completion Date: Jul 1, 2014
• Actual Study Completion Date: Jul 1, 2014

Arms and Interventions

Arm	Intervention/Treatment
Placebo Comparator: standard double lumen tube Intervention: Standard double lumen tube	Device: Standard double lumen tube; Endotracheal left side double lumen tube
Experimental: VivaSight double lumen tube Intervention: VivaSight double lumen tube	Device: VivaSight double lumen tube; VivaSight double lumen endotracheal intubation

Outcome Measures

Primary Outcome Measures

1. Time required for endotracheal intubation with visual confirmation of double lumen tube position position. [During induction of general anesthesia]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Rambam Health Care Campus

Investigators

• Principal Investigator: Dan Levy-Faber, Dr., Senior Surgeon, Department of Cardio-Thoracic Surgery

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Rambam Health Care Campus
• ClinicalTrials.gov Identifier: NCT02253979
• Other Study ID Numbers: 0334-12-RMB_CTIL
• First Posted: Oct 1, 2014
• Last Update Posted: Oct 1, 2014
• Last Verified: Sep 1, 2014

Study Results

No Results Posted as of Oct 1, 2014