Ultrasound Guided Percutaneous Tracheostomy Compared to Bronchoscopy Guided Percutaneous Tracheostomy

Not Applicable

Completed

• Conditions: Tracheostomy Complications
• Interventions: Device: Bronchoscopy guided percutaneous tracheostomy; Device: Ultrasound guided percutaneous tracheostomy

• Registration Number: NCT02084862
• Lead Sponsor: University of Sao Paulo

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.

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2014-02-05
• Study Start: 2014-03
• Study First Submitted QC: 2014-03-09
• Study First Posted: 2014-03-12
• Primary Completion: 2015-05
• Study Completion: 2015-06
• Status Verified: 2015-10
• Last Update Submitted: 2015-10-26
• Last Update Posted: 2015-10-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 118

Inclusion Criteria

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

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Bronchoscopy	Bronchoscopy guided percutaneous tracheostomy	Bronchoscopy guided percutaneous tracheostomy
Ultrasound	Ultrasound guided percutaneous tracheostomy	Ultrasound guided percutaneous tracheostomy

Primary Outcome Measures

Name	Time	Method
Procedure failure	During PDT - an expected average of 15 minutes	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.

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Hospital das Cínicas da Universidade de São Paulo; 🇧🇷 Sao Paulo, Brazil