Ultrasound Guided Percutaneous Tracheostomy Compared to Bronchoscopy Guided Percutaneous Tracheostomy

NCT ID: NCT02084862

Last Updated: 2015-10-28

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

118 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-03-31

Study Completion Date

2015-06-30

Brief Summary

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TRACHUS trial is a randomized non-inferiority trial designed to evaluate the safety and efficacy of ultrasound guided percutaneous tracheostomy compared to bronchoscopy guided percutaneous tracheostomy.

Detailed Description

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TRACHUS trial is a randomized non-inferiority trial designed to evaluate the safety and efficacy of ultrasound guided percutaneous tracheostomy compared to bronchoscopy guided percutaneous tracheostomy.

Patients will be randomly assigned to be submitted to ultrasound or bronchoscopy guided percutaneous tracheostomy and then the procedure related complications and clinical outcomes will be evaluated and compared between groups.

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

Ultrasound guided percutaneous tracheostomy

Intervention Type DEVICE

Bronchoscopy guided percutaneous tracheostomy

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 by the ICU assistant team

Exclusion Criteria

* Patients with unfavorable anatomy judged by the patient assistant team (short neck, tracheal deviation, cervical anatomical anomaly, previous cervical surgery, cervical trauma or inability to perform neck extension), preference for surgical tracheostomy by the patient assistant team or patients unable to provide informed consent.
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Sao Paulo

OTHER

Sponsor Role lead

Responsible Party

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Luiz Marcelo Sá Malbouisson

MD, PhD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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André Gobatto, MD

Role: PRINCIPAL_INVESTIGATOR

University of Sao Paulo

Locations

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Hospital das Cínicas da Universidade de São Paulo

São Paulo, São Paulo, Brazil

Site Status

Countries

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Brazil

Other Identifiers

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488506

Identifier Type: OTHER

Identifier Source: secondary_id

11410

Identifier Type: -

Identifier Source: org_study_id

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