Percutaneous TracheostomyNCT01522027
Electrically Guided Needle Insertion: ICU Study
A study testing Percutaneous tracheostomy in people with Percutaneous Tracheostomy, run by University of Alberta at 1 site in Canada.
Trial summary
Critically ill patients or patients under prolonged unconsciousness need a tube inserted into their windpipe to provide oxygen. This tube, called a tracheostomy tube, can be connected to a ventilation device to allow the patient to breathe when they cannot do it for themselves. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Percutaneous Tracheostomy
- What is being tested?
- Percutaneous tracheostomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteCanada
- Study dates
- May 2012to Nov 2017
- 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 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult (> 18 yrs)
- Requires tracheostomy
Who cannot join
- Failure to provide consent
- Known upper airway pathologies
- Known oro-pharyngeal or laryngeal disease, including any swelling, tumour, or infection
- Previous radiotherapy or operations on the neck
- Cervical spine fractures.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Use of Nerve Stimulation Technology to Aid in Percutaneous Tracheostomy in Intensive Care Patients.
Critically ill patients or patients under prolonged unconsciousness need a tube inserted into their windpipe to provide oxygen. This tube, called a tracheostomy tube, can be connected to a ventilation device to allow the patient to breathe when they cannot do it for themselves. In the hospital, doctors will perform a percutaneous tracheostomy (PT), where a needle is inserted through the skin of the neck into the windpipe, providing a guide for a tube that will dilate the tissue and create a hole that the tracheostomy tube can be inserted into. Although this is a common procedure in critical care units, it does carry some risks to the patient and is not always successful. The needle may puncture the back or side of the windpipe if it is inserted too far, or it can miss the windpipe altogether, causing damage to surrounding structures. We believe that doctors who perform PT would benefit from a method that improves the success rate of the procedure. We wish to test a device that alerts the doctor performing PT to when the needle tip is in the air-filled windpipe. The device has been proven to aid needle insertion in cadavers, but it needs to be tested on live patients. Since many intensive care patients undergo PT, we wish to test our technique on this population. It will be a controlled environment and the clinicians are experienced in PT. This technique should save valuable time, result in more accurate needle insertion, and lessen the risk of damaging other structures and tissues in the neck.
Read the detailed description
Background: Critically ill patients occasionally require a tracheostomy tube to breathe. A percutaneous tracheostomy can be performed, where a needle/catheter is inserted into the trachea, followed by insertion of a guidewire and a tube that dilates the tissue, creating a hole for the tracheostomy tube. Although this is a common procedure, it does pose risks to the patient, including accidental puncture of nearby structures. We wish to test a device that alerts the doctor to when the needle tip is in the tracheal lumen. The device has been proven to aid needle insertion in cadavers, but it needs to be tested on live patients. Since many intensive care patients undergo PT, we wish to test our technique on this population.
Study objective: To evaluate the effectiveness of a nerve stimulator in aiding needle tracheostomy in live patients.
Hypothesis: Nerve stimulation equipment will help the physician guide and insert the needle tip into the tracheal lumen faster and with more accuracy than conventional techniques.
Primary outcome: speed and accuracy of needle tip placement in the trachea.
Procedure: This study will involve recruiting consenting adult patients from the University of Alberta Hospital General Systems Intensive Care Unit (ICU) who require percutaneous tracheostomy to insert a tracheal tube. In this population, a tracheostomy is usually performed as a means to provide long-term assisted ventilation without the need for endotracheal intubation. Briefly, the patient is sedated, the skin on their neck disinfected, and a local anesthetic injected into the anterior neck. A bronchoscope is inserted down the endotracheal tube to aid in visualization and localization of needle puncture. The cricothyroid membrane is located by palpating the anterior neck and an incision is made over the membrane. A small needle is inserted through the membrane to act as a guide for a larger needle-catheter assembly. Both needles are removed and a guidewire is inserted through the catheter. Using forceps, the insertion site is widened and a tube to dilate the opening is inserted. The tracheostomy tube is then inserted and the dilation tube and guidewire are removed. The endotracheal tube is removed and the ventilation apparatus is connected to the tracheostomy tube.
We will supply ICU physicians with a commonly used nerve stimulator (Stimuplex HNS 12, B.Braun, Germany) to attach to the needle-catheter assembly used to make the first insertion into the trachea. The nerve stimulator will be connected to a current meter, and a ground electrode will be attached to the body. When the needle tip is in contact with body tissue (i.e., tracheal wall), the electrical circuit will be closed, producing a reading of 1.0 mA on the current reader. Suspension of the needle tip in the airway will interrupt the circuit, producing a reading of 0.0 mA. In addition, an audible signal built into the nerve stimulator will alert the user to a change in current, warning that the needle tip has advanced too far and is in contact with the posterior or lateral tracheal wall.
The physician will perform percutaneous tracheostomy on 20 ICU patients that require endotracheal extubation and insertion of a tracheostomy tube. This will help support our preliminary observations which showed that the nerve stimulator was helpful in guiding needle insertion using human cadavers. By showing that the technique is equally as effective when used on live patients, we can argue that a nerve stimulator or similar device can ensure accurate, quick, and safe needle insertion when accessing the airway percutaneously.
Inclusion criteria: Adult; requires tracheostomy
Exclusion criteria: Failure to provide consent; known upper airway pathologies; known oro-pharyngeal or laryngeal disease, including any swelling, tumour, or infection; previous radiotherapy or operations on the neck; cervical spine fractures.
- Conditions
- Percutaneous Tracheostomy
- Being tested
- Percutaneous tracheostomy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Percutaneous tracheostomyProcedure or surgery
Twenty ICU patients will receive percutaneous tracheostomy via insertion of a needle/catheter connected to a nerve stimulator.
| Study group | Role | What they receive |
|---|---|---|
| Nerve stimulator | Experimental | Twenty ICU patients will receive percutaneous tracheostomy via insertion of a needle/catheter connected to a nerve stimulator. Receives: Procedure: Percutaneous tracheostomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Speed and accuracy of needle tip placement in the tracheal lumen
The speed and accuracy with which a needle/catheter assembly connected to a nerve stimulator is inserted through the cricothyroid membrane into the tracheal lumen will be measured.
Measured: From positioning of the patient to withdrawal of needle; approximately 5 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jan 2012 (estimated)
- Study startMay 2012
- Primary completionNov 2017
- Study completionNov 2017
Why it stopped: No participants enrolled
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Percutaneous TracheostomyStudies of the same condition, open and under way.
- 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
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Alberta
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ban Tsui, MD, MSc, Principal investigator, University of Alberta
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01522027
- Sponsor's protocol ID
- Pro000026880
- Status last verified
- Dec 2014
- First submitted
- 26 Jan 2012
- Last updated
- 25 Mar 2020
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of Nerve Stimulation Technology to Aid in Percutaneous Tracheostomy in Intensive Care Patients.
- ClinicalTrials.gov ID
- NCT01522027
- Acronym / sponsor ID
- Pro000026880
- Conditions
- Percutaneous Tracheostomy
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: No participants enrolled
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of AlbertaUniversity, hospital or other
- Study start
- May 2012 (actual)
- Primary completion
- Nov 2017 (actual)
- Study completion
- Nov 2017 (actual)
- First posted
- 31 Jan 2012 (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.
Critically ill patients or patients under prolonged unconsciousness need a tube inserted into their windpipe to provide oxygen. This tube, called a tracheostomy tube, can be connected to a ventilation device to allow the patient to breathe when they cannot do it for themselves. In the hospital, doctors will perform a percutaneous tracheostomy (PT), where a needle is inserted through the skin of the neck into the windpipe, providing a guide for a tube that will dilate the tissue and create a hole that the tracheostomy tube can be inserted into. Although this is a common procedure in critical care units, it does carry some risks to the patient and is not always successful. The needle may puncture the back or side of the windpipe if it is inserted too far, or it can miss the windpipe altogether, causing damage to surrounding structures. We believe that doctors who perform PT would benefit from a method that improves the success rate of the procedure. We wish to test a device that alerts the doctor performing PT to when the needle tip is in the air-filled windpipe. The device has been proven to aid needle insertion in cadavers, but it needs to be tested on live patients. Since many intensive care patients undergo PT, we wish to test our technique on this population. It will be a controlled environment and the clinicians are experienced in PT. This technique should save valuable time, result in more accurate needle insertion, and lessen the risk of damaging other structures and tissues in the neck.
Detailed description
Background: Critically ill patients occasionally require a tracheostomy tube to breathe. A percutaneous tracheostomy can be performed, where a needle/catheter is inserted into the trachea, followed by insertion of a guidewire and a tube that dilates the tissue, creating a hole for the tracheostomy tube. Although this is a common procedure, it does pose risks to the patient, including accidental puncture of nearby structures. We wish to test a device that alerts the doctor to when the needle tip is in the tracheal lumen. The device has been proven to aid needle insertion in cadavers, but it needs to be tested on live patients. Since many intensive care patients undergo PT, we wish to test our technique on this population.
Study objective: To evaluate the effectiveness of a nerve stimulator in aiding needle tracheostomy in live patients.
Hypothesis: Nerve stimulation equipment will help the physician guide and insert the needle tip into the tracheal lumen faster and with more accuracy than conventional techniques.
Primary outcome: speed and accuracy of needle tip placement in the trachea.
Procedure: This study will involve recruiting consenting adult patients from the University of Alberta Hospital General Systems Intensive Care Unit (ICU) who require percutaneous tracheostomy to insert a tracheal tube. In this population, a tracheostomy is usually performed as a means to provide long-term assisted ventilation without the need for endotracheal intubation. Briefly, the patient is sedated, the skin on their neck disinfected, and a local anesthetic injected into the anterior neck. A bronchoscope is inserted down the endotracheal tube to aid in visualization and localization of needle puncture. The cricothyroid membrane is located by palpating the anterior neck and an incision is made over the membrane. A small needle is inserted through the membrane to act as a guide for a larger needle-catheter assembly. Both needles are removed and a guidewire is inserted through the catheter. Using forceps, the insertion site is widened and a tube to dilate the opening is inserted. The tracheostomy tube is then inserted and the dilation tube and guidewire are removed. The endotracheal tube is removed and the ventilation apparatus is connected to the tracheostomy tube.
We will supply ICU physicians with a commonly used nerve stimulator (Stimuplex HNS 12, B.Braun, Germany) to attach to the needle-catheter assembly used to make the first insertion into the trachea. The nerve stimulator will be connected to a current meter, and a ground electrode will be attached to the body. When the needle tip is in contact with body tissue (i.e., tracheal wall), the electrical circuit will be closed, producing a reading of 1.0 mA on the current reader. Suspension of the needle tip in the airway will interrupt the circuit, producing a reading of 0.0 mA. In addition, an audible signal built into the nerve stimulator will alert the user to a change in current, warning that the needle tip has advanced too far and is in contact with the posterior or lateral tracheal wall.
The physician will perform percutaneous tracheostomy on 20 ICU patients that require endotracheal extubation and insertion of a tracheostomy tube. This will help support our preliminary observations which showed that the nerve stimulator was helpful in guiding needle insertion using human cadavers. By showing that the technique is equally as effective when used on live patients, we can argue that a nerve stimulator or similar device can ensure accurate, quick, and safe needle insertion when accessing the airway percutaneously.
Inclusion criteria: Adult; requires tracheostomy
Exclusion criteria: Failure to provide consent; known upper airway pathologies; known oro-pharyngeal or laryngeal disease, including any swelling, tumour, or infection; previous radiotherapy or operations on the neck; cervical spine fractures.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Nerve stimulator | Experimental | Procedure: Percutaneous tracheostomyTwenty ICU patients will receive percutaneous tracheostomy via insertion of a needle/catheter connected to a nerve stimulator. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Adult (> 18 yrs)
- Requires tracheostomy
Key exclusion criteria (5 listed)
- Failure to provide consent
- Known upper airway pathologies
- Known oro-pharyngeal or laryngeal disease, including any swelling, tumour, or infection
- Previous radiotherapy or operations on the neck
- Cervical spine fractures.
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 |
|---|---|---|
| Percutaneous tracheostomyTwenty ICU patients will receive percutaneous tracheostomy via insertion of a needle/catheter connected to a nerve stimulator. | Procedure or surgery | Nerve stimulator |
Primary outcome
Speed and accuracy of needle tip placement in the tracheal lumen
Time frame: From positioning of the patient to withdrawal of needle; approximately 5 minutes
The speed and accuracy with which a needle/catheter assembly connected to a nerve stimulator is inserted through the cricothyroid membrane into the tracheal lumen will be measured.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Mar 2020.
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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.
Ban Tsui, MD, MSc principal investigator
University of Alberta
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Percutaneous tracheostomy in people with Percutaneous Tracheostomy, run by University of Alberta at 1 site in Canada.
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 2 inclusion and 5 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: withdrawn, as of the sponsor's last update on 25 Mar 2020. 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 Canada. 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 was withdrawn before enrolling participants, so there are no results.
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?
Speed and accuracy of needle tip placement in the tracheal lumen (time frame: From positioning of the patient to withdrawal of needle; approximately 5 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 25 Mar 2020.