Comparison Between Bronchoscopy and Real- Time Ultrasound Guided Percutaneous Tracheostomy

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-08-31

Study Completion Date

2016-09-30

Brief Summary

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Trial is a randomized study to compare between ultrasound guided percutaneous tracheostomy and bronchoscopy guided percutaneous tracheostomy.

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Detailed Description

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Trial is a randomized study to compare between ultrasound guided percutaneous tracheostomy and bronchoscopy guided percutaneous tracheostomy.

Patients will be randomly assigned to be submitted to evaluate safety, complication rates, easy to perform , clinical outcomes and effectivity.

Conditions

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Tracheostomy Complications

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Ultrasound

Ultrasound guided percutaneous tracheostomy

Group Type EXPERIMENTAL

Ultrasound guided percutaneous tracheostomy

Intervention Type DEVICE

Ultrasound guided percutaneous tracheostomy

Bronchoscopy

Bronchoscopy guided percutaneous tracheostomy

Group Type ACTIVE_COMPARATOR

Bronchoscopy guided percutaneous tracheostomy

Intervention Type DEVICE

Bronchoscopy guided percutaneous tracheostomy

Interventions

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Ultrasound guided percutaneous tracheostomy

Intervention Type DEVICE

Bronchoscopy guided percutaneous tracheostomy

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* All intubated and mechanically ventilated patients indicated for a tracheostomy

Exclusion Criteria

* Patients with tracheal or neck abnormalities, soft tissue infection in the neck, neck surgery history, oxygenation problems , coagulation disorders or coagulation parameter changes and those requiring urgent or surgery patients unable to provide informed consent.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No