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"TRAcheostomy With Single Use Bronchoscopes vs. Conventional Bronchoscopes"

NCT03952247 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 46

Last updated 2019-11-19

No results posted yet for this study

Summary

Optical guidance for percutaneous tracheostomy in intensive care is usually performed by conventional multi use bronchoscopy. Recently a single use bronchoscope has been introduced that allows for endotracheal visualization.

For feasibility evaluation, 23 patients in intensive care receive percutaneous tracheostomy with optical guidance by the Ambu® aScopeTM 4 bronchoscope and 23 patients in intensive care receive percutaneous tracheostomy with a conventional bronchoscope (Olympus BF Type P60). The primary end point is the visualization through the single use bronchoscope of endotracheal landmark structures for tracheostomy and visualization of the needle insertion (according to score, see detailed description).

Conditions

  • Respiratory Insufficiency

Interventions

DEVICE

Single Use Bronchoscopy for PDT

optical guidance of percutaneous tracheotomy is done by single use bronchoscopy

DEVICE

Conventional Multi Use Bronchoscopy for PDT

optical guidance of percutaneous tracheotomy is done by conventional multi use bronchoscopy

Sponsors & Collaborators

  • Universitätsklinikum Hamburg-Eppendorf

    lead OTHER

Principal Investigators

  • Jörn Grensemann, MD · 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
2019-05-15
Primary Completion
2019-11-01
Completion
2019-11-04

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 NCT03952247 on ClinicalTrials.gov