Electrically Guided Needle Insertion: Transtracheal Injection

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified July 2015 by University of Alberta
Information provided by (Responsible Party):
University of Alberta
ClinicalTrials.gov Identifier:
First received: November 17, 2011
Last updated: August 10, 2015
Last verified: July 2015
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: 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 ] [ Designated as safety issue: No ]
    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 2016
Estimated Study Completion Date: July 2017
Estimated Primary Completion Date: December 2016 (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


Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01495273

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

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
Principal Investigator: Ban Tsui, MD University of Alberta
  More Information

No publications provided

Responsible Party: University of Alberta
ClinicalTrials.gov Identifier: NCT01495273     History of Changes
Other Study ID Numbers: Pro00026789
Study First Received: November 17, 2011
Last Updated: August 10, 2015
Health Authority: Canada: Ethics Review Committee

ClinicalTrials.gov processed this record on November 27, 2015