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

Performance and Safety of an Airway Management Device Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01757977
• Other study ID #: C.A.751
• Status: Completed
• Phase: N/A
• First received: December 22, 2012
• Last updated: March 15, 2013
• Start date: August 2012
• Est. completion date: January 2013

Study information

• Verified date: March 2013
• Source: University College Hospital Galway
• Contact: n/a
• Is FDA regulated: No
• Health authority: Ireland: Research Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 25
• Est. completion date: January 2013
• Est. primary completion date: January 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 16 Years to 85 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Performance and Safety of an Airway Management Device

Intervention

Device:
• double lumen endotracheal tube placement and use

Locations

Country	Name	City	State
Ireland	Galway University Hospitals	Galway

Sponsors (1)

Lead Sponsor	Collaborator
John Laffey

Country where clinical trial is conducted

Ireland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Time to confirmation of tube position		within 60 minutes of commencement of general anesthesia	No
Secondary	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	No
Secondary	Time from initial laryngoscopy to passing tube through vocal cords		Within 60 minutes of commencement of general anesthesia	No
Secondary	rate of malposition	the investigators will record the number/type of tube position adjustment maneuvers	within 15 hours of commencement of general anesthesia	Yes
Secondary	need to pass a fiberoptic bronchoscope during case		within 15 hours of commencement of general anesthesia	No
Secondary	presence of blood at the carina immediately post intubation		within 60 minutes of commencement of general anesthesia	Yes