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Ultrasound Guided Percutaneous Tracheostomy Compared to Bronchoscopy Guided Percutaneous Tracheostomy (TRACHUS)

U

University of Sao Paulo

Status

Completed

Conditions

Tracheostomy Complications

Treatments

Device: Ultrasound guided percutaneous tracheostomy
Device: Bronchoscopy guided percutaneous tracheostomy

Study type

Interventional

Funder types

Other

Identifiers

NCT02084862
11410
488506 (Other Identifier)

Details and patient eligibility

About

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.

Full description

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.

Enrollment

118 patients

Sex

All

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

118 participants in 2 patient groups

Ultrasound
Experimental group
Description:
Ultrasound guided percutaneous tracheostomy
Treatment:
Device: Ultrasound guided percutaneous tracheostomy
Bronchoscopy
Active Comparator group
Description:
Bronchoscopy guided percutaneous tracheostomy
Treatment:
Device: Bronchoscopy guided percutaneous tracheostomy

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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