Clinical trial 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
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Performance and Safety of an Airway Management Device
Keywords: Vivasight DL
double lumen endotracheal tube
fiberoptic confirmation of tube position
Lead sponsor: University College Hospital Galway
Sponsor class: OTHER
First posted: 2012-12-31
Enrollment: 25
Sex: ALL
Minimum age (years): 16
Maximum age (years): 85
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Adequacy of optical view obtained to confirm optimal tube position.
timeFrame: within 60 minutes of commencement of general anesthesia
Secondary outcomes:
measure: Time to confirmation of tube position
timeFrame: within 60 minutes of commencement of general anesthesia
measure: Operator rated Device Difficulty Score
timeFrame: within 60 minutes of commencement of general anesthesia
measure: Time from initial laryngoscopy to passing tube through vocal cords
timeFrame: Within 60 minutes of commencement of general anesthesia
measure: rate of malposition
timeFrame: within 15 hours of commencement of general anesthesia
measure: need to pass a fiberoptic bronchoscope during case
timeFrame: within 15 hours of commencement of general anesthesia
measure: presence of blood at the carina immediately post intubation
timeFrame: within 60 minutes of commencement of general anesthesia
Other outcomes:
Locations:
city: Galway
country: Ireland
facility: Galway University Hospitals
Study officials:
affiliation: Galway University Hospitals
name: Brian Harte, FFARCSI
role: PRINCIPAL_INVESTIGATOR
References: