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

John Laffey

Status: Completed

Conditions: Performance and Safety of an Airway Management Device

Treatments: Device: double lumen endotracheal tube placement and use

Study type: Interventional

Funder types: Other

Identifiers

NCT01757977

C.A.751

Details and patient eligibility

About

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.

Full 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.

Enrollment: 25 patients

Sex: All

Ages: 16 to 85 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

25 participants in 2 patient groups

Vivasight DL

Experimental group

Description:

placement and intraoperative use of Vivasight DL double lumen endobronchial tube

Treatment:

Device: double lumen endotracheal tube placement and use

standard DLT

Active Comparator group

Description:

placement and intraoperative use of a standard double lumen endotracheal tube.

Treatment:

Device: double lumen endotracheal tube placement and use