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Electrically Guided Needle Insertion: Transtracheal Injection

This study is not yet open for participant recruitment.
Verified October 2016 by University of Alberta
Sponsor:
ClinicalTrials.gov Identifier:
NCT01495273
First Posted: December 20, 2011
Last Update Posted: October 26, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
University of Alberta
  Purpose
Various medical procedures require different objects to be inserted into the airway; for example, a bronchoscope - a fibreoptic camera device - can be guided down the windpipe to gain real-time images of the airway. Since inserting objects down the throat is uncomfortable for most patients, doctors have several options, one of which is putting the patient to sleep using general anesthetic before inserting something into the windpipe. This may not always be the best option, especially in cases where the patient needs to be awake during the procedure. In these cases, the doctor may 'freeze' the windpipe before inserting a scope or a tube into the airway. For this, the doctor inserts a needle through the front of the neck and injects local anesthetic. Inserting a needle into the windpipe comes with some risks to the patient, and the doctor wants to avoid puncturing nearby structures, such as arteries, veins, and the esophagus. The investigators have come up with a new method for accurately guiding a needle into the airway that will alert the user when they have successfully placed the needle tip in the windpipe. The investigators hypothesize that this new method will prove to be beneficial to clinicians and emergency medical personnel who need a fast, easy, and reliable way to insert a needle into the airway.

Condition Intervention
Transtracheal Injection Fibreoptic Intubation Procedure: Transtracheal injection

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Adaptation of Nerve Stimulation Technology to Aid Transtracheal Needle Insertion and Injection

Further study details as provided by University of Alberta:

Primary Outcome Measures:
  • Needle tip placement in tracheal lumen [ Time Frame: From positioning of the patient to anesthesia of the trachea; approximately 10 minutes ]
    After injection of local anesthetic into the skin of the neck, a needle connected to a syringe containing 4-6 mL 2-4% lidocaine will be inserted through the cricothyroid membrane into the tracheal lumen. Success will be recorded as accurate puncture of the cricothyroid membrane and trachea and injection of lidocaine into the tracheal lumen.


Estimated Enrollment: 30
Study Start Date: May 2017
Estimated Study Completion Date: July 2018
Estimated Primary Completion Date: December 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Nerve stimulator
Experimental group; will undergo transtracheal injection with needle connected to nerve stimulator.
Procedure: Transtracheal injection
Experimental group will undergo transtracheal injection using needle connected to a nerve stimulator device.
Active Comparator: Standard needle/syringe
Control group; will undergo transtracheal injection with standard needle/syringe assembly.
Procedure: Transtracheal injection
Control group will undergo transtracheal injection with a standard needle/syringe assembly.

  Show Detailed Description

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Adult (18 years of age or older) patients who have provided informed consent.
  • Require awake fibreoptic intubation.

Exclusion Criteria:

  • Inability to consent due to language barrier or incapacity to 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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01495273


Contacts
Contact: Ban Tsui, MD 780-407-8604 btsui@ualberta.ca

Locations
Canada, Alberta
University of Alberta Hospital Not yet recruiting
Edmonton, Alberta, Canada, T6G 2B7
Principal Investigator: Ban Tsui, MD, MSc         
Sub-Investigator: Gareth Corry, PhD         
Sponsors and Collaborators
University of Alberta
Investigators
Principal Investigator: Ban Tsui, MD University of Alberta
  More Information

Responsible Party: University of Alberta
ClinicalTrials.gov Identifier: NCT01495273     History of Changes
Other Study ID Numbers: Pro00026789
First Submitted: November 17, 2011
First Posted: December 20, 2011
Last Update Posted: October 26, 2016
Last Verified: October 2016