Electrically Guided Needle Insertion: Transtracheal Injection

NCT01495273 | Withdrawn

• 1 other identifier: Pro00026789
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Transtracheal Injection; Fibreoptic Intubation

Outcome Measures

Primary Outcomes (1)

• Needle tip placement in tracheal lumen

  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.

  From positioning of the patient to anesthesia of the trachea; approximately 10 minutes

Study Arms (2)

Nerve stimulator

EXPERIMENTAL

Experimental group; will undergo transtracheal injection with needle connected to nerve stimulator.

Procedure: Transtracheal injection

Standard needle/syringe

ACTIVE COMPARATOR

Control group; will undergo transtracheal injection with standard needle/syringe assembly.

Procedure: Transtracheal injection

Interventions

Transtracheal injection PROCEDURE

Experimental group will undergo transtracheal injection using needle connected to a nerve stimulator device.

Nerve stimulator

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Alberta: lead

Study Sites (1)

University of Alberta Hospital

Edmonton, Alberta, T6G 2B7, Canada

Location

Study Officials

• Ban Tsui, MD

  University of Alberta

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 17, 2011
• First Posted: December 20, 2011
• Study Start: May 1, 2017
• Primary Completion: December 1, 2017
• Study Completion: January 1, 2018
• Last Updated: March 24, 2020

Record last verified: 2020-03

Locations

CA (1)