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VivaSight-SL™ Versus Bronchoscopy for Percutaneous Tracheotomy

NCT02861001 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 56

Last updated 2017-03-23

No results posted yet for this study

Summary

Optical guidance for percutaneous tracheotomy in intensive care is usually performed by bronchoscopy. Recently, an endotracheal tube with a camera mounted at its tip (VivaSight-SL) has been introduced that allows for endotracheal visualization.

For feasibility evaluation, ten patients in intensive care receive percutaneous tracheotomy with optical guidance by the VivaSight-SL tube. If this part is completed with satisfactory results, patients are randomized to receive optical guidance by bronchoscopy or by VivaSight-SL tube. The primary end point is the visualization through the tube camera of endotracheal landmark structures for tracheotomy and visualization of the needle insertion (according to score, see detailed description).

Conditions

  • Respiratory Insufficiency

Interventions

DEVICE

conventional bronchoscopy

optical guidance of percutaneous tracheotomy is done by conventional bronchoscopy

DEVICE

VivaSight-SL tube

optical guidance of percutaneous tracheotomy is done by the VivaSight-SL tube

Sponsors & Collaborators

  • Universitätsklinikum Hamburg-Eppendorf

    lead OTHER

Principal Investigators

  • Stefan Kluge, MD, PhD · Head of Dept. of Intensive Care Medicine

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-04-30
Primary Completion
2017-01-13
Completion
2017-01-13

Countries

  • Germany

Study Locations

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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 NCT02861001 on ClinicalTrials.gov