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Completed

NCT Number: NCT01757977

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.

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Key information

Age range

16 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Galway University Hospitals

Galway, Ireland

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

double lumen endotracheal tube placement and use

Device

Primary outcomes

  1. Adequacy of optical view obtained to confirm optimal tube position.

    Time frame: within 60 minutes of commencement of general anesthesia

    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 outcomes

  1. Time to confirmation of tube position

    Time frame: within 60 minutes of commencement of general anesthesia

  2. Operator rated Device Difficulty Score

    Time frame: within 60 minutes of commencement of general anesthesia

    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.

  3. Time from initial laryngoscopy to passing tube through vocal cords

    Time frame: Within 60 minutes of commencement of general anesthesia

  4. rate of malposition

    Time frame: within 15 hours of commencement of general anesthesia

    the investigators will record the number/type of tube position adjustment maneuvers

  5. need to pass a fiberoptic bronchoscope during case

    Time frame: within 15 hours of commencement of general anesthesia

  6. presence of blood at the carina immediately post intubation

    Time frame: within 60 minutes of commencement of general anesthesia

Sponsors and collaborators

Lead sponsor

John Laffey

Other

Registry information

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
Dec 31, 2012
Registry last updated
Mar 19, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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