Clinical trial NCT02084862: Ultrasound Guided Percutaneous Tracheostomy Compared to Bronchoscopy Guided Percutaneous Tracheostomy
Official title: Ultrasound Guided Percutaneous Tracheostomy Compared to Bronchoscopy Guided Percutaneous Tracheostomy - A Randomized Non-inferiority Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Tracheostomy Complications
Keywords: Tracheostomy
Ultrasound
Lead sponsor: University of Sao Paulo
Sponsor class: OTHER
First posted: 2014-03-12
Enrollment: 118
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Procedure failure
timeFrame: During PDT - an expected average of 15 minutes
Secondary outcomes:
measure: Hypoxemia
timeFrame: During PDT - an expected average of 15 minutes
measure: Hypotension
timeFrame: During PDT - an expected average of 15 minutes
measure: Pneumothorax
timeFrame: Participants will be followed for the duration of hospital stay, an expected average of 4 weeks
measure: Atelectasis
timeFrame: Participants will be followed for the duration of hospital stay, an expected average of 4 weeks
measure: Conversion to surgical tracheostomy
timeFrame: During PDT - an expected average of 15 minutes
measure: Tracheal posterior wall injury
timeFrame: Participants will be followed for the duration of hospital stay, an expected average of 4 weeks
measure: Accidental decanulation
timeFrame: Participants will be followed for the duration of hospital stay, an expected average of 4 weeks
measure: Cardiorespiratoty arrest
timeFrame: During PDT - an expected average of 15 minutes
measure: Death
timeFrame: Participants will be followed for the duration of hospital stay, an expected average of 4 weeks
measure: Liberation from mechanical ventilation
timeFrame: Participants will be followed for the duration of hospital stay, an expected average of 4 weeks
measure: Length of ICU Stay
timeFrame: Participants will be followed for the duration of hospital stay, an expected average of 4 weeks
measure: Length of Hospital Stay
timeFrame: Participants will be followed for the duration of hospital stay, an expected average of 4 weeks
measure: Length of Mechanical Ventilation
timeFrame: Participants will be followed for the duration of hospital stay, an expected average of 4 weeks
measure: Surgical site infection
timeFrame: Participants will be followed for the duration of hospital stay, an expected average of 4 weeks
measure: Tracheal ring fracture
timeFrame: Participants will be followed for the duration of hospital stay, an expected average of 4 weeks
measure: Tracheal-esophageal fistula
timeFrame: Participants will be followed for the duration of hospital stay, an expected average of 4 weeks
measure: Minor bleeding
timeFrame: Participants will be followed for the duration of hospital stay, an expected average of 4 weeks
measure: Major bleeding
timeFrame: During the procedure - an expected average of 15 minutes
measure: Major bleeding
timeFrame: Participants will be followed for the duration of hospital stay, an expected average of 4 weeks
Other outcomes:
measure: Procedure duration
timeFrame: During PDT - an expected average of 15 minutes
measure: Time to procedure performance
timeFrame: Participants will be followed for the duration of hospital stay, an expected average of 4 weeks
Locations:
city: Sao Paulo
country: Brazil
facility: Hospital das Cínicas da Universidade de São Paulo
Study officials:
affiliation: University of Sao Paulo
name: André Gobatto, MD
role: PRINCIPAL_INVESTIGATOR
References: