Tracheostomy ComplicationsTRACHUSNCT02084862
Ultrasound Guided Percutaneous Tracheostomy Compared to Bronchoscopy Guided Percutaneous Tracheostomy
A study testing Ultrasound guided percutaneous tracheostomy and Bronchoscopy guided percutaneous tracheostomy in people with Tracheostomy Complications, run by University of Sao Paulo at 1 site in Brazil.
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Tracheostomy Complications
- What is being tested?
- Ultrasound guided percutaneous tracheostomy and Bronchoscopy guided percutaneous tracheostomy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 118 participants
- Where
- 1 siteBrazil
- Study dates
- Mar 2014to Jun 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- All intubated and mechanically ventilated patients indicated for a tracheostomy by the ICU assistant team
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Hospital das Cínicas da Universidade de São Paulo
São Paulo, São Paulo
About this study
Official title: 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.
Read the 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.
- Conditions
- Tracheostomy Complications
- Being tested
- Ultrasound guided percutaneous tracheostomy, Bronchoscopy guided percutaneous tracheostomy
- Keywords
- Tracheostomy, Ultrasound
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ultrasound guided percutaneous tracheostomyDevice
Ultrasound guided percutaneous tracheostomy
Bronchoscopy guided percutaneous tracheostomyDevice
Bronchoscopy guided percutaneous tracheostomy
| Study group | Role | What they receive |
|---|---|---|
| Ultrasound | Experimental | Ultrasound guided percutaneous tracheostomy Receives: Device: Ultrasound guided percutaneous tracheostomy |
| Bronchoscopy | Active comparator | Bronchoscopy guided percutaneous tracheostomy Receives: Device: Bronchoscopy guided percutaneous tracheostomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: During PDT - an expected average of 15 minutes
Secondary outcomes (19)
Hypoxemia
Drop in peripheral oxygen saturation < 90% for more than 2 minutes as measured by pulse oxymeter during the procedure
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: During PDT - an expected average of 15 minutes
Tracheal posterior wall injury
Tracheal posterior wall injury as detected by bronchoscopy after the procedure
Measured: Participants will be followed for the duration of hospital stay, an expected average of 4 weeks
Accidental decanulation
Accidental decanulation after the procedure during Hospital stay
Measured: Participants will be followed for the duration of hospital stay, an expected average of 4 weeks
Cardiorespiratoty arrest
Cardiorespiratory arrest due to PDT
Measured: During PDT - an expected average of 15 minutes
Death
Death due to PDT complications
Measured: 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
Measured: Participants will be followed for the duration of hospital stay, an expected average of 4 weeks
Length of ICU Stay
Length of ICU Stay
Measured: Participants will be followed for the duration of hospital stay, an expected average of 4 weeks
Length of Hospital Stay
Length of Hospital Stay
Measured: Participants will be followed for the duration of hospital stay, an expected average of 4 weeks
Length of Mechanical Ventilation
Length of Mechanical Ventilation
Measured: 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
Measured: 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
Measured: 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
Measured: 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.
Measured: 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
Measured: 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
Measured: Participants will be followed for the duration of hospital stay, an expected average of 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2014 (estimated)
- Study startMar 2014
- Primary completionMay 2015
- Study completionJun 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tracheostomy ComplicationsStudies of the same condition, open and under way.
- More trials run by University of Sao PauloThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 118 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Sao Paulo
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Luiz Marcelo Sá Malbouisson, University of Sao Paulo
- Investigators
- André Gobatto, MD, Principal investigator, University of Sao Paulo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02084862
- Sponsor's protocol ID
- 11410
- Other IDs
- 488506
- Acronym
- TRACHUS
- Status last verified
- Oct 2015
- First submitted
- 5 Feb 2014
- Last updated
- 28 Oct 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Oct 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ultrasound Guided Percutaneous Tracheostomy Compared to Bronchoscopy Guided Percutaneous Tracheostomy - A Randomized Non-inferiority Trial
- ClinicalTrials.gov ID
- NCT02084862
- Acronym / sponsor ID
- TRACHUS / 11410
- Conditions
- Tracheostomy Complications
- Keywords
- Tracheostomy, Ultrasound
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 118 participants (actual)
- Lead sponsor
- University of Sao PauloUniversity, hospital or other
- Study start
- Mar 2014
- Primary completion
- May 2015 (actual)
- Study completion
- Jun 2015 (actual)
- First posted
- 12 Mar 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ultrasound | Experimental | Device: Ultrasound guided percutaneous tracheostomyUltrasound guided percutaneous tracheostomy |
| Bronchoscopy | Active comparator | Device: Bronchoscopy guided percutaneous tracheostomyBronchoscopy guided percutaneous tracheostomy |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- All intubated and mechanically ventilated patients indicated for a tracheostomy by the ICU assistant team
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ultrasound guided percutaneous tracheostomyUltrasound guided percutaneous tracheostomy | Device | Ultrasound |
| Bronchoscopy guided percutaneous tracheostomyBronchoscopy guided percutaneous tracheostomy | Device | Bronchoscopy |
Primary outcome
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.
19 secondary outcomes
Hypoxemia
Time frame: During PDT - an expected average of 15 minutes
Hypotension
Time frame: During PDT - an expected average of 15 minutes
Pneumothorax
Time frame: Participants will be followed for the duration of hospital stay, an expected average of 4 weeks
Atelectasis
Time frame: Participants will be followed for the duration of hospital stay, an expected average of 4 weeks
Conversion to surgical tracheostomy
Time frame: During PDT - an expected average of 15 minutes
Tracheal posterior wall injury
Time frame: Participants will be followed for the duration of hospital stay, an expected average of 4 weeks
Accidental decanulation
Time frame: Participants will be followed for the duration of hospital stay, an expected average of 4 weeks
Cardiorespiratoty arrest
Time frame: During PDT - an expected average of 15 minutes
Death
Time frame: Participants will be followed for the duration of hospital stay, an expected average of 4 weeks
Liberation from mechanical ventilation
Time frame: Participants will be followed for the duration of hospital stay, an expected average of 4 weeks
Length of ICU Stay
Time frame: Participants will be followed for the duration of hospital stay, an expected average of 4 weeks
Length of Hospital Stay
Time frame: Participants will be followed for the duration of hospital stay, an expected average of 4 weeks
Length of Mechanical Ventilation
Time frame: Participants will be followed for the duration of hospital stay, an expected average of 4 weeks
Surgical site infection
Time frame: Participants will be followed for the duration of hospital stay, an expected average of 4 weeks
Tracheal ring fracture
Time frame: Participants will be followed for the duration of hospital stay, an expected average of 4 weeks
Tracheal-esophageal fistula
Time frame: Participants will be followed for the duration of hospital stay, an expected average of 4 weeks
Minor bleeding
Time frame: Participants will be followed for the duration of hospital stay, an expected average of 4 weeks
Major bleeding
Time frame: During the procedure - an expected average of 15 minutes
Major bleeding
Time frame: Participants will be followed for the duration of hospital stay, an expected average of 4 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Oct 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
André Gobatto, MD principal investigator
University of Sao Paulo
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ultrasound guided percutaneous tracheostomy and Bronchoscopy guided percutaneous tracheostomy in people with Tracheostomy Complications, run by University of Sao Paulo at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Oct 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Procedure failure (time frame: During PDT - an expected average of 15 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Oct 2015.