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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
John Laffey, University College Hospital Galway
ClinicalTrials.gov Identifier:
NCT01757977
First received: December 22, 2012
Last updated: March 15, 2013
Last verified: March 2013
  Purpose

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.


Condition Intervention
Performance and Safety of an Airway Management Device
Device: double lumen endotracheal tube placement and use

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: A Comparison of the Performance of Standard Double Lumen Tubes With Vivasight DL™ Double Lumen Tubes for Lung Isolation in Patients Undergoing Thoracic Surgery

Further study details as provided by University College Hospital Galway:

Primary Outcome Measures:
  • Adequacy of optical view obtained to confirm optimal tube position. [ Time Frame: within 60 minutes of commencement of general anesthesia ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Time to confirmation of tube position [ Time Frame: within 60 minutes of commencement of general anesthesia ] [ Designated as safety issue: No ]
  • Operator rated Device Difficulty Score [ Time Frame: within 60 minutes of commencement of general anesthesia ] [ Designated as safety issue: No ]
    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.

  • Time from initial laryngoscopy to passing tube through vocal cords [ Time Frame: Within 60 minutes of commencement of general anesthesia ] [ Designated as safety issue: No ]
  • rate of malposition [ Time Frame: within 15 hours of commencement of general anesthesia ] [ Designated as safety issue: Yes ]
    the investigators will record the number/type of tube position adjustment maneuvers

  • need to pass a fiberoptic bronchoscope during case [ Time Frame: within 15 hours of commencement of general anesthesia ] [ Designated as safety issue: No ]
  • presence of blood at the carina immediately post intubation [ Time Frame: within 60 minutes of commencement of general anesthesia ] [ Designated as safety issue: Yes ]

Enrollment: 25
Study Start Date: August 2012
Study Completion Date: January 2013
Primary Completion Date: January 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   16 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01757977

Locations
Ireland
Galway University Hospitals
Galway, Ireland
Sponsors and Collaborators
John Laffey
Investigators
Principal Investigator: Brian Harte, FFARCSI Galway University Hospitals
  More Information

No publications provided

Responsible Party: John Laffey, Professor of Anaesthesia and Critical Care, Consultant Anaesthetist, University College Hospital Galway
ClinicalTrials.gov Identifier: NCT01757977     History of Changes
Other Study ID Numbers: C.A.751
Study First Received: December 22, 2012
Last Updated: March 15, 2013
Health Authority: Ireland: Research Ethics Committee

Keywords provided by University College Hospital Galway:
Vivasight DL
double lumen endotracheal tube
fiberoptic confirmation of tube position

ClinicalTrials.gov processed this record on April 14, 2014