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Completed

NCT Number: NCT02084862

Ultrasound Guided Percutaneous Tracheostomy Compared to Bronchoscopy Guided Percutaneous Tracheostomy

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.

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Key information

Conditions

Tracheostomy Complications

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hospital das Cínicas da Universidade de São Paulo

São Paulo, Brazil

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Ultrasound guided percutaneous tracheostomy

Device

Ultrasound guided percutaneous tracheostomy

Bronchoscopy guided percutaneous tracheostomy

Device

Bronchoscopy guided percutaneous tracheostomy

Primary outcomes

  1. Procedure failure

    Time frame: 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 outcomes

  1. Hypoxemia

    Time frame: 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

  2. Hypotension

    Time frame: 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.

  3. Pneumothorax

    Time frame: 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.

  4. Atelectasis

    Time frame: 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.

  5. Conversion to surgical tracheostomy

    Time frame: During PDT - an expected average of 15 minutes

    Conversion to surgical tracheostomy due to technical limitations or complications during PDT.

  6. Tracheal posterior wall injury

    Time frame: 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

  7. Accidental decanulation

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

    Accidental decanulation after the procedure during Hospital stay

  8. Cardiorespiratoty arrest

    Time frame: During PDT - an expected average of 15 minutes

    Cardiorespiratory arrest due to PDT

  9. Death

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

    Death due to PDT complications

  10. Liberation from mechanical ventilation

    Time frame: 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

  11. Length of ICU Stay

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

    Length of ICU Stay

  12. Length of Hospital Stay

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

    Length of Hospital Stay

  13. Length of Mechanical Ventilation

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

    Length of Mechanical Ventilation

  14. Surgical site infection

    Time frame: 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

  15. Tracheal ring fracture

    Time frame: 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

  16. Tracheal-esophageal fistula

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

    Trachealesophageal fistula detected by bronchosocopy after PDT

  17. Minor bleeding

    Time frame: 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.

  18. Major bleeding

    Time frame: During the procedure - an expected average of 15 minutes

    Blood transfusion or hypotension or surgical intervention in the operating room due to bleeding during PDT

  19. Major bleeding

    Time frame: 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

Other outcomes

  1. Procedure duration

    Time frame: During PDT - an expected average of 15 minutes

    Time elapsed between skin incision and connection of mechanical ventilation to tracheostomy cannula

  2. Time to procedure performance

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

    Time elapsed between participant randomization and PDT performance

Sponsors and collaborators

Lead sponsor

University of Sao Paulo

Other

Registry information

Official study title

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

Acronym: TRACHUS

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Mar 12, 2014
Registry last updated
Oct 28, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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