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

Ultrasound Guided Percutaneous Tracheostomy Compared to Bronchoscopy Guided Percutaneous Tracheostomy - A Randomized Non-inferiority Trial

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.

Study Overview

• Status: Completed
• Conditions: Tracheostomy Complications
• Intervention / Treatment: Device: Ultrasound guided percutaneous tracheostomy; Device: Bronchoscopy guided percutaneous tracheostomy

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 118
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Brazil
  • Sao Paulo, Brazil
    • Hospital das Cínicas da Universidade de São Paulo

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Ultrasound; Ultrasound guided percutaneous tracheostomy	Device: Ultrasound guided percutaneous tracheostomy; Ultrasound guided percutaneous tracheostomy
Active Comparator: Bronchoscopy; Bronchoscopy guided percutaneous tracheostomy	Device: Bronchoscopy guided percutaneous tracheostomy; Bronchoscopy guided percutaneous tracheostomy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Tracheal posterior wall injury	Tracheal posterior wall injury as detected by bronchoscopy after the procedure	Participants will be followed for the duration of hospital stay, an expected average of 4 weeks
Hypoxemia	Drop in peripheral oxygen saturation < 90% for more than 2 minutes as measured by pulse oxymeter during the procedure	During PDT - an expected average of 15 minutes
Hypotension	Systolic blood pressure < 90mmHg for more than 5 minutes and any intervention aimed to raise blood pressure such as vasopressor or fluid administration.	During PDT - an expected average of 15 minutes
Pneumothorax	Pneumothorax due to the PDT detected by clinical examination during the procedure or chest x-ray after the procedure.	Participants will be followed for the duration of hospital stay, an expected average of 4 weeks
Atelectasis	Atelectasis due to the PDT detected by clinical examination during the procedure or chest x-ray after the procedure.	Participants will be followed for the duration of hospital stay, an expected average of 4 weeks
Conversion to surgical tracheostomy	Conversion to surgical tracheostomy due to technical limitations or complications during PDT.	During PDT - an expected average of 15 minutes
Accidental decanulation	Accidental decanulation after the procedure during Hospital stay	Participants will be followed for the duration of hospital stay, an expected average of 4 weeks
Cardiorespiratoty arrest	Cardiorespiratory arrest due to PDT	During PDT - an expected average of 15 minutes
Death	Death due to PDT complications	Participants will be followed for the duration of hospital stay, an expected average of 4 weeks
Liberation from mechanical ventilation	Breathing without ventilator assistance for at least 48 hours after the PDT	Participants will be followed for the duration of hospital stay, an expected average of 4 weeks
Length of ICU Stay	Length of ICU Stay	Participants will be followed for the duration of hospital stay, an expected average of 4 weeks
Length of Hospital Stay	Length of Hospital Stay	Participants will be followed for the duration of hospital stay, an expected average of 4 weeks
Length of Mechanical Ventilation	Length of Mechanical Ventilation	Participants will be followed for the duration of hospital stay, an expected average of 4 weeks
Surgical site infection	Surgical site infection defined as antibiotic introduction directed to surgical site	Participants will be followed for the duration of hospital stay, an expected average of 4 weeks
Tracheal ring fracture	Tracheal ring fracture detected by bronchosocopy after the PDT	Participants will be followed for the duration of hospital stay, an expected average of 4 weeks
Tracheal-esophageal fistula	Trachealesophageal fistula detected by bronchosocopy after PDT	Participants will be followed for the duration of hospital stay, an expected average of 4 weeks
Minor bleeding	Clinical relevant bleeding attributed to PDT defined as need for any intervention to stop the bleeding such as vessel ligature or local wound care.	Participants will be followed for the duration of hospital stay, an expected average of 4 weeks
Major bleeding	Blood transfusion or hypotension or surgical intervention in the operating room due to bleeding during PDT	During the procedure - an expected average of 15 minutes
Major bleeding	Blood transfusion or hypotension or surgical intervention in the operating room due to bleeding related to PDT during hospital stay after the procedure	Participants will be followed for the duration of hospital stay, an expected average of 4 weeks

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Procedure duration	Time elapsed between skin incision and connection of mechanical ventilation to tracheostomy cannula	During PDT - an expected average of 15 minutes
Time to procedure performance	Time elapsed between participant randomization and PDT performance	Participants will be followed for the duration of hospital stay, an expected average of 4 weeks

Collaborators and Investigators

• Sponsor: University of Sao Paulo
• Investigators: Principal Investigator: André Gobatto, MD, University of Sao Paulo

Study record dates

Study Major Dates

• Study Start: March 1, 2014
• Primary Completion (Actual): May 1, 2015
• Study Completion (Actual): June 1, 2015

Study Registration Dates

• First Submitted: February 5, 2014
• First Submitted That Met QC Criteria: March 9, 2014
• First Posted (Estimate): March 12, 2014

Study Record Updates

• Last Update Posted (Estimate): October 28, 2015
• Last Update Submitted That Met QC Criteria: October 26, 2015
• Last Verified: October 1, 2015

More Information

Terms related to this study

• Keywords: Ultrasound; Tracheostomy
• Other Study ID Numbers: 11410; 488506 (Other Identifier: CAPPesq)