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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.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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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.

Canada1 site
  • University of Alberta Hospital

    Edmonton, Alberta, T6G 2B7

Other trials in Canada

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.

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 groups in NCT01522027
Study groupRoleWhat they receive
Nerve stimulatorExperimentalTwenty 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.

  1. 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.

  1. First posted31 Jan 2012 (estimated)
  2. Study startMay 2012
  3. Primary completionNov 2017
  4. Study completionNov 2017

Why it stopped: No participants enrolled

Resources

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)
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

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.

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