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NCT02253979 Clinical Trial

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

Airway Management Clinical Trial

Official title:
Comparison of VivaSightTM Double Lumen Tube With a Conventional Double Lumen Tube in Adult Patients Undergoing Video Assisted Thoracoscopic Surgery

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02253979
Other study ID # 0334-12-RMB_CTIL
Secondary ID
Status Completed
Phase Phase 4
First received September 28, 2014
Last updated September 30, 2014
Start date January 2013
Est. completion date July 2014

Study information
Verified date September 2014
Source Rambam Health Care Campus
Contact n/a
Is FDA regulated No
Health authority Israel: Ministry of Health
Study type Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Completed
Enrollment 71
Est. completion date July 2014
Est. primary completion date July 2014
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Device:
• Standard double lumen tube
Endotracheal left side double lumen tube
• VivaSight double lumen tube
VivaSight double lumen endotracheal intubation

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Rambam Health Care Campus

References & Publications (3)

Heir JS, Purugganan R, Jackson TA, Norman PH, Cata JP, Kosturakis A, Thakar D. A retrospective evaluation of the use of video-capable double-lumen endotracheal tubes in thoracic surgery. J Cardiothorac Vasc Anesth. 2014 Aug;28(4):870-2. doi: 10.1053/j.jvc — View Citation

Inoue S, Nishimine N, Kitaguchi K, Furuya H, Taniguchi S. Double lumen tube location predicts tube malposition and hypoxaemia during one lung ventilation. Br J Anaesth. 2004 Feb;92(2):195-201. — View Citation

Klein U, Karzai W, Bloos F, Wohlfarth M, Gottschall R, Fritz H, Gugel M, Seifert A. Role of fiberoptic bronchoscopy in conjunction with the use of double-lumen tubes for thoracic anesthesia: a prospective study. Anesthesiology. 1998 Feb;88(2):346-50. — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary Time required for endotracheal intubation with visual confirmation of double lumen tube position position. During induction of general anesthesia No
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