Prospective, Randomized Clinical Trial Evaluating the ETView Double-Lumen Tube
1 other identifier
interventional
40
1 country
1
Brief Summary
No prospective randomized clinical trial assessed the performance of this new device in a clinical setting. Consequently the aim of this study is to determine clinical performance of this new device compared with conventional DLT.
- Trial with medical device
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 Mar 2013
Shorter than P25 for phase_4
1 active site
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
March 1, 2013
CompletedFirst Submitted
Initial submission to the registry
March 7, 2013
CompletedFirst Posted
Study publicly available on registry
March 8, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2014
CompletedApril 28, 2014
April 1, 2014
11 months
March 7, 2013
April 25, 2014
Conditions
Outcome Measures
Primary Outcomes (1)
time to intubation
Time for intubation, defined as "time from insertion of the laryngoscope until statement of the intubating anesthesiologist, that DLT was correctly placed". Time for intubation will be measured by an independent researcher using a stop watch.
300 seconds
Secondary Outcomes (9)
Rate of misplacement
3 hours
Rate of misplacement
3 hours
Rate of blind insertion
300 seconds
rate of fibreoptic bronchoscopy
3 hours
Quality of lung collapse
3 hours
- +4 more secondary outcomes
Study Arms (2)
ET View Double Lumen Tube
ACTIVE COMPARATORPatients assigned to the thisgroup will be intubated using the VivaSight-DL.
conventional Double Lumen Tube
ACTIVE COMPARATORPatients assigned to the first group will be intubated using conventional DLT (Bronchocath, left sided; Rüsch, Kernen, Germany).
Interventions
Eligibility Criteria
You may qualify if:
- Elective thoracic surgery with anticipated use of a DLT
- Anticipated extubation in the operating room;
- American Society of Anesthesiologist Physical Status 1-3;
- Age 18- 90.
- Written consent (signature from patient)
You may not qualify if:
- Tracheal pathology, including tracheostomy;
- Any form of infection (including upper-respiratory tract infection or pneumonia) or suspected tuberculosis;
- BMI higher exceeding 40 kg/m2;
- Known or suspected difficult airway.
- Pregnancy
- Breast feeding
- The subject must not be involved in any other clinical trial during the course of this trial, nor within a period of 30 days prior to its beginning or 30 days after its completion
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University Hospital Zurich, Division of Anaesthesiology
Zurich, Canton of Zurich, 8091, Switzerland
Related Publications (1)
Schuepbach R, Grande B, Camen G, Schmidt AR, Fischer H, Sessler DI, Seifert B, Spahn DR, Ruetzler K. Intubation with VivaSight or conventional left-sided double-lumen tubes: a randomized trial. Can J Anaesth. 2015 Jul;62(7):762-9. doi: 10.1007/s12630-015-0329-8. Epub 2015 Feb 6.
PMID: 25663254DERIVED
Study Officials
- PRINCIPAL INVESTIGATOR
Beatrice Beck Schimmer, Prof MD
University Hospital Zurich, Division of Anaesthesiology
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
March 7, 2013
First Posted
March 8, 2013
Study Start
March 1, 2013
Primary Completion
February 1, 2014
Study Completion
March 1, 2014
Last Updated
April 28, 2014
Record last verified: 2014-04