NCT02084862

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
118

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2014

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 5, 2014

Completed
24 days until next milestone

Study Start

First participant enrolled

March 1, 2014

Completed
11 days until next milestone

First Posted

Study publicly available on registry

March 12, 2014

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2015

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2015

Completed
Last Updated

October 28, 2015

Status Verified

October 1, 2015

Enrollment Period

1.2 years

First QC Date

February 5, 2014

Last Update Submit

October 26, 2015

Conditions

Tracheostomy Complications

Keywords

TracheostomyUltrasound

Outcome Measures

Primary Outcomes (1)

  • Procedure failure

    Combined endpoint procedure failure (defined as conversion to surgical tracheostomy, or associated use of bronchoscopy in the case of ultrasound-guided tracheostomy or associated use of ultrasound in bronchoscopy-guided tracheostomy) or occurrence of of a major complications defined as transfusion, hypotension or surgical intervention in the operative room due to bleeding, tracheal laceration, tracheal posterior wall injury, esophageal injury, tracheoesophageal fistula, cardiorespiratory arrest or death due to tracheostomy.

    During PDT - an expected average of 15 minutes

Secondary Outcomes (19)

  • Hypoxemia

    During PDT - an expected average of 15 minutes

  • Hypotension

    During PDT - an expected average of 15 minutes

  • Pneumothorax

    Participants will be followed for the duration of hospital stay, an expected average of 4 weeks

  • Atelectasis

    Participants will be followed for the duration of hospital stay, an expected average of 4 weeks

  • Conversion to surgical tracheostomy

    During PDT - an expected average of 15 minutes

  • +14 more secondary outcomes

Other Outcomes (2)

  • Procedure duration

    During PDT - an expected average of 15 minutes

  • Time to procedure performance

    Participants will be followed for the duration of hospital stay, an expected average of 4 weeks

Study Arms (2)

Ultrasound

EXPERIMENTAL

Ultrasound guided percutaneous tracheostomy

Device: Ultrasound guided percutaneous tracheostomy

Bronchoscopy

ACTIVE COMPARATOR

Bronchoscopy guided percutaneous tracheostomy

Device: Bronchoscopy guided percutaneous tracheostomy

Interventions

Ultrasound guided percutaneous tracheostomyDEVICE

Ultrasound guided percutaneous tracheostomy

Ultrasound
Bronchoscopy guided percutaneous tracheostomyDEVICE

Bronchoscopy guided percutaneous tracheostomy

Bronchoscopy

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • All intubated and mechanically ventilated patients indicated for a tracheostomy by the ICU assistant team

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital das Cínicas da Universidade de São Paulo

São Paulo, São Paulo, Brazil

Location

Study Officials

  • André Gobatto, MD

    University of Sao Paulo

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, PhD

Study Record Dates

First Submitted

February 5, 2014

First Posted

March 12, 2014

Study Start

March 1, 2014

Primary Completion

May 1, 2015

Study Completion

June 1, 2015

Last Updated

October 28, 2015

Record last verified: 2015-10

Locations

BR(1)