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

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.

Study Overview

• Status: Completed
• Conditions: Performance and Safety of an Airway Management Device
• Intervention / Treatment: Device: double lumen endotracheal tube placement and use

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.

• Study Type: Interventional
• Enrollment (Actual): 25
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Ireland
  • Galway, Ireland
    • Galway University Hospitals

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 85 years (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Vivasight DL; placement and intraoperative use of Vivasight DL double lumen endobronchial tube	Device: double lumen endotracheal tube placement and use
Active Comparator: standard DLT; placement and intraoperative use of a standard double lumen endotracheal tube.	Device: double lumen endotracheal tube placement and use

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adequacy of optical view obtained to confirm optimal tube position.	The 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.	within 60 minutes of commencement of general anesthesia

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time to confirmation of tube position		within 60 minutes of commencement of general anesthesia
Operator rated Device Difficulty Score	The investigators will use 10cm visual analogue scale (VAS) to rate the overall ease of device use till successful placement achieved and position confirmed optically.	within 60 minutes of commencement of general anesthesia
Time from initial laryngoscopy to passing tube through vocal cords		Within 60 minutes of commencement of general anesthesia
rate of malposition	the investigators will record the number/type of tube position adjustment maneuvers	within 15 hours of commencement of general anesthesia
need to pass a fiberoptic bronchoscope during case		within 15 hours of commencement of general anesthesia
presence of blood at the carina immediately post intubation		within 60 minutes of commencement of general anesthesia

Collaborators and Investigators

• Sponsor: John Laffey
• Investigators: Principal Investigator: Brian Harte, FFARCSI, Galway University Hospitals

Study record dates

Study Major Dates

• Study Start: August 1, 2012
• Primary Completion (Actual): January 1, 2013
• Study Completion (Actual): January 1, 2013

Study Registration Dates

• First Submitted: December 22, 2012
• First Submitted That Met QC Criteria: December 22, 2012
• First Posted (Estimate): December 31, 2012

Study Record Updates

• Last Update Posted (Estimate): March 19, 2013
• Last Update Submitted That Met QC Criteria: March 15, 2013
• Last Verified: March 1, 2013

More Information

Terms related to this study

• Keywords: Vivasight DL; double lumen endotracheal tube; fiberoptic confirmation of tube position
• Other Study ID Numbers: C.A.751