Comparison of VivaSightTM Double Lumen Tube With a Conventional Double Lumen Tube
1 other identifier
interventional
71
0 countries
N/A
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_4
Started Jan 2013
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2014
CompletedFirst Submitted
Initial submission to the registry
September 28, 2014
CompletedFirst Posted
Study publicly available on registry
October 1, 2014
CompletedOctober 1, 2014
September 1, 2014
1.5 years
September 28, 2014
September 30, 2014
Conditions
Outcome Measures
Primary Outcomes (1)
Time required for endotracheal intubation with visual confirmation of double lumen tube position position.
During induction of general anesthesia
Study Arms (2)
standard double lumen tube
PLACEBO COMPARATORIntervention: Standard double lumen tube
VivaSight double lumen tube
EXPERIMENTALIntervention: VivaSight double lumen tube
Interventions
VivaSight double lumen endotracheal intubation
Eligibility Criteria
You may qualify if:
- adult patients undergoing video assisted thoracoscopic lung lobectomy
You may not qualify if:
- anticipated difficult intubation, patients who required rapid sequence induction
- patients with known tracheal pathology
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Related Publications (3)
Heir JS, Purugganan R, Jackson TA, Norman PH, Cata JP, Kosturakis A, Thakar D. A retrospective evaluation of the use of video-capable double-lumen endotracheal tubes in thoracic surgery. J Cardiothorac Vasc Anesth. 2014 Aug;28(4):870-2. doi: 10.1053/j.jvca.2013.11.011. Epub 2014 Mar 20.
PMID: 24656617RESULTInoue S, Nishimine N, Kitaguchi K, Furuya H, Taniguchi S. Double lumen tube location predicts tube malposition and hypoxaemia during one lung ventilation. Br J Anaesth. 2004 Feb;92(2):195-201. doi: 10.1093/bja/aeh055.
PMID: 14722168RESULTKlein U, Karzai W, Bloos F, Wohlfarth M, Gottschall R, Fritz H, Gugel M, Seifert A. Role of fiberoptic bronchoscopy in conjunction with the use of double-lumen tubes for thoracic anesthesia: a prospective study. Anesthesiology. 1998 Feb;88(2):346-50. doi: 10.1097/00000542-199802000-00012.
PMID: 9477054RESULT
Study Officials
- PRINCIPAL INVESTIGATOR
Dan Levy-Faber, Dr.
Senior Surgeon, Department of Cardio-Thoracic Surgery
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 28, 2014
First Posted
October 1, 2014
Study Start
January 1, 2013
Primary Completion
July 1, 2014
Study Completion
July 1, 2014
Last Updated
October 1, 2014
Record last verified: 2014-09