A Comparison of the Performance of Standard Double Lumen Tubes With Vivasight DL™ Double Lumen Tubes for Lung Isolation in Patients Undergoing Thoracic Surgery

NCT ID: NCT01757977

Last Updated: 2013-03-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 25 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-08-31
• Study Completion Date: 2013-01-31

Brief Summary

The investigators have performed a number of studies on novel airway devices. In this randomized controlled trial he investigators would like to compare the performance of a new double-lumen endotracheal tube incorporating internal camera (Vivasight DL) with a standard double lumen tube.

Detailed Description

Single lung ventilation is frequently carried out to facilitate surgery on the lungs and pleura. In most instances this is achieved by insertion of a double-lumen endotracheal tube and then selectively ventilating one lung or both. Precise positioning of these tubes is essential for optimal performance. It has become the standard of care to perform bronchoscopy to confirm tube position.

A new double lumen endotracheal tube (Vivasight DL) has recently been developed. It has all the features of a standard double lumen endotracheal tube but also incorporates an internal camera which, when connected to an external screen, allows continuous confirmation of tube position.

This is randomized, single blinded controlled trial. The participants will be allocated to two study groups (Vivasight DL or standard DLT), in which the primary airway management device will be respectively Vivasight DL double lumen tube or a standard double lumen endotracheal tube.

Clinical Research Ethics Committee approval has been obtained. Suitable participants will be recruited after written informed consent.

Standard anesthetic preassessment and anesthesia will be provided.

Consenting patients passing the inclusion and exclusion criteria will be randomly allocated to either of the 2 study groups.

Protocol for attempts at placement and tube position confirmation will be followed.

The investigators will monitor a number of parameters, including time and ease of tube insertion, ability to verify tube position with the primary imaging modality for each group, need to perform tube position adjustment maneuvers, need to use fiberoptic bronchoscope during the case, quality of lung collapse, problems with ventilation and other.

The primary hypothesis is that the new Vivasight DL tube system will provide a comparable optical view to the fiberoptic scope view obtained via standard double lumen endotracheal tube in order to confirm optimal position.

Conditions

Performance and Safety of an Airway Management Device

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Vivasight DL

placement and intraoperative use of Vivasight DL double lumen endobronchial tube

Group Type: EXPERIMENTAL

double lumen endotracheal tube placement and use

Intervention Type: DEVICE

standard DLT

placement and intraoperative use of a standard double lumen endotracheal tube.

Group Type: ACTIVE_COMPARATOR

double lumen endotracheal tube placement and use

Intervention Type: DEVICE

Interventions

double lumen endotracheal tube placement and use

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• 16 - 85 yr old patients capable of informed consent
• ASA (American Society of Anesthesiologists physical status) 1-3
• non-emergency surgery of expected duration < 6 hours
• one-lung ventilation required

Exclusion Criteria

• BMI > 35
• expected difficult airway
• Mallampati score >2
• increased risk of aspiration
• upper airway or upper GI problems
• live pregnancy

• Minimum Eligible Age: 16 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

John Laffey

OTHER

Sponsor Role: lead

Responsible Party

John Laffey

Professor of Anaesthesia and Critical Care, Consultant Anaesthetist

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Brian Harte, FFARCSI

Role: PRINCIPAL_INVESTIGATOR

Galway University Hospitals

Locations

Galway University Hospitals

Galway, , Ireland

Countries

Ireland

Other Identifiers

C.A.751

Identifier Type: -

Identifier Source: org_study_id