Comparison of VivaSightTM Double Lumen Tube With a Conventional Double Lumen Tube

Rambam Health Care Campus

Status and phase: Completed; Phase 4

Conditions: Airway Management; Endotracheal Intubation; One Lung Ventilation

Treatments: Device: VivaSight double lumen tube; Device: Standard double lumen tube

Study type: Interventional

Funder types: Other

Identifiers

NCT02253979

0334-12-RMB_CTIL

Details and patient eligibility

About

Double lumen tube (DLT) is an enotracheal tube that facilitates one lung ventilation. The DLT exact position in the airways is verified by fiber-optic bronchoscopy (FOB) after intubation. The VivaSight TM DL is a single use left DLT with a camera embedded in the tube's right side port. This study was designed to compare the VivaSightTM DL to the standard DLT.

Full description

Double lumen tube (DLT) is an enotracheal tube that facilitates one lung ventilation. The efficiency of the DLT depends on its exact position in the airways, as verified by fiber-optic bronchoscopy (FOB) after intubation, and re-verified after positioning the patient on the lateral position. The VivaSight TM DL is a single use left DLT with a camera embedded in the tube's right side port. The view from the camera appears continuously on a monitor. This study was designed to compare the VivaSightTM DL to the standard DLT. The primary end point is the time required for intubation with visual confirmation of DLT position.

Enrollment: 71 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• adult patients undergoing video assisted thoracoscopic lung lobectomy

Exclusion criteria

• anticipated difficult intubation, patients who required rapid sequence induction
• patients with known tracheal pathology

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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71 participants in 2 patient groups, including a placebo group

standard double lumen tube

Placebo Comparator group

Description:

Intervention: Standard double lumen tube

Treatment:

Device: Standard double lumen tube

VivaSight double lumen tube

Experimental group

Description:

Intervention: VivaSight double lumen tube

Treatment:

Device: VivaSight double lumen tube