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

NCT ID: NCT02253979

Last Updated: 2014-10-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 71 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-01-31
• Study Completion Date: 2014-07-31

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.

Conditions

Endotracheal Intubation; Airway Management; One Lung Ventilation

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

standard double lumen tube

Intervention: Standard double lumen tube

Group Type: PLACEBO_COMPARATOR

Standard double lumen tube

Intervention Type: DEVICE

Endotracheal left side double lumen tube

VivaSight double lumen tube

Intervention: VivaSight double lumen tube

Group Type: EXPERIMENTAL

VivaSight double lumen tube

Intervention Type: DEVICE

VivaSight double lumen endotracheal intubation

Interventions

Standard double lumen tube

Endotracheal left side double lumen tube

Intervention Type: DEVICE

VivaSight double lumen tube

VivaSight double lumen endotracheal intubation

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Rambam Health Care Campus

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Dan Levy-Faber, Dr.

Role: PRINCIPAL_INVESTIGATOR

Senior Surgeon, Department of Cardio-Thoracic Surgery

References

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.jvca.2013.11.011. Epub 2014 Mar 20.

Reference Type: RESULT

PMID: 24656617 (View on PubMed)

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. doi: 10.1093/bja/aeh055.

Reference Type: RESULT

PMID: 14722168 (View on PubMed)

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. doi: 10.1097/00000542-199802000-00012.

Reference Type: RESULT

PMID: 9477054 (View on PubMed)

Other Identifiers

0334-12-RMB_CTIL

Identifier Type: -

Identifier Source: org_study_id