N/A Completed N=50 Randomized Single-blind Other

VivaSight Double Lumen Tube for Single Lung Ventilation

Double Lumen Endotracheal Tube · Single Lung Ventilation

Source: ClinicalTrials.gov NCT03690284 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Dec 2021

Primary outcomePrimary: Number of Participants Requiring Flexible Fiberoptic Bronchoscopy — 25; 7 Participants

Summary

This prospective, randomized, comparative study is intended to enroll a total of 50 patients undergoing thoracic surgery that necessitates single lung ventilation. The efficacy and performance of the VivaSight DLT will be compared to the conventional double lumen tube. Use of fiberoptic bronchoscopy for initial tube positioning and subsequently during the case will be recorded. The attending thoracic surgeon will judge the quality of lung deflation. The occurrence of any malposition and subsequent maneuvers will be recorded. A standardized anesthetic protocol that is usual and customary for the type of operation the patient is having will be provided to the anesthesia teams of enrolled subjects. The remainder of the anesthetic care of the subject will not deviate from the standard of care.

Outcome Measures

Outcome	Result	p-value
PRIMARY Number of Participants Requiring Flexible Fiberoptic Bronchoscopy	25; 7	—
SECONDARY The Intubation Time	156; 54	—
SECONDARY Number of Participants With Malposition	12; 4	—
SECONDARY The Cost of Double Lumen Tube Intubation	—	—

Eligibility Criteria

Inclusion Criteria

18-90 years old
Scheduled for a thoracic surgery that requires single lung ventilation
Willing and able to consent in English or Spanish

Exclusion Criteria

Age less than 18 or older than 90
Patient does not speak English or Spanish
Patient refusal
Pregnant or nursing women
Known or suspected difficult airway
Contraindication for left sided double lumen tube (e.g, L bronchial mass)

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT03690284). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.