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Lung Isolation in Thoracic Surgery - a Randomized Trial Comparing the VivaSight™ EB Endobronchial Blocker With Established Devices

NCT02912598 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 104

Last updated 2016-09-23

No results posted yet for this study

Summary

Surgery involving the chest cavity, particularly VATS procedures, often require one-lung ventilation. The double-lumen tube (DLT) is considered the gold standard for lung isolation with different models of bronchial blockers (BB) used in special populations and circumstances. Their routine use is impeded by prolonged placement times, frequent malpositionings and higher costs when compared to the DLT, as recently reported in a meta-analysis by Clayton-Smith et al. The VivaSight™ SL+EB as a combination of a single-lumen tube with an integrated camera and a bronchial blocker allows for endobronchial placement without the use of a fiberoptic bronchoscope. An external monitor provides continuous visualization of the tracheal carina and the position of the bronchial cuff. The purpose of this study was to evaluate the clinical performance of the VivaSight™ SL+EB when compared to a left-sided double-lumen tube and established bronchial blockers. The investigators hypothesized a reduction in time to initial lung isolation due to the simplified placement procedure compared to other bronchial blockers. Continuous intraprocedural airway visualization may allow for early detection of dislocations. Necessary repositionings may be possible without additional bronchoscopies, reducing both disruptions of ventilation and maintenance costs.

Conditions

  • Lung Separation Techniques
  • One-Lung Ventilation

Interventions

DEVICE

Mallinckrodt™ Endobronchial Tube

DEVICE

Fuji Uniblocker™

DEVICE

ETView VivaSight™-SL+EB

DEVICE

COOK© Arndt Endobronchial Blocker

Sponsors & Collaborators

  • Otto-von-Guericke University Magdeburg

    lead OTHER

Principal Investigators

  • Thomas Hachenberg, Prof. Dr. med. · Klinik für Anaesthesiologie und Intensivtherapie der Otto-von-Guericke-Universität / Medizinische Fakultät Universitätsklinikum Magdeburg A.ö.R.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-01-31
Primary Completion
2015-11-30
Completion
2015-11-30

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02912598 on ClinicalTrials.gov