Ultrasound Guided Percutaneous Tracheostomy Compared to Bronchoscopy Guided Percutaneous Tracheostomy

Tracheostomy Complications Clinical Trial

— TRACHUS  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02084862
• Other study ID #: 11410
• Secondary ID: 488506
• Status: Completed
• Phase: N/A
• First received: February 5, 2014
• Last updated: October 26, 2015
• Start date: March 2014
• Est. completion date: June 2015

Study information

• Verified date: October 2015
• Source: University of Sao Paulo
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 118
• Est. completion date: June 2015
• Est. primary completion date: May 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Postoperative Complications
• Tracheostomy Complications

Intervention

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

Locations

Country	Name	City	State
Brazil	Hospital das Cínicas da Universidade de São Paulo	Sao Paulo

Sponsors (1)

Lead Sponsor	Collaborator
University of Sao Paulo

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Procedure duration	Time elapsed between skin incision and connection of mechanical ventilation to tracheostomy cannula	During PDT - an expected average of 15 minutes	No
Other	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	No
Primary	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	Yes
Secondary	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	Yes
Secondary	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	Yes
Secondary	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	Yes
Secondary	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	Yes
Secondary	Conversion to surgical tracheostomy	Conversion to surgical tracheostomy due to technical limitations or complications during PDT.	During PDT - an expected average of 15 minutes	Yes
Secondary	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	Yes
Secondary	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	Yes
Secondary	Cardiorespiratoty arrest	Cardiorespiratory arrest due to PDT	During PDT - an expected average of 15 minutes	Yes
Secondary	Death	Death due to PDT complications	Participants will be followed for the duration of hospital stay, an expected average of 4 weeks	Yes
Secondary	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	No
Secondary	Length of ICU Stay	Length of ICU Stay	Participants will be followed for the duration of hospital stay, an expected average of 4 weeks	No
Secondary	Length of Hospital Stay	Length of Hospital Stay	Participants will be followed for the duration of hospital stay, an expected average of 4 weeks	No
Secondary	Length of Mechanical Ventilation	Length of Mechanical Ventilation	Participants will be followed for the duration of hospital stay, an expected average of 4 weeks	No
Secondary	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	Yes
Secondary	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	No
Secondary	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	Yes
Secondary	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	Yes
Secondary	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	Yes
Secondary	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	Yes