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Electrically Guided Needle Insertion: ICU Study

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2012 by University of Alberta
Sponsor:
Information provided by (Responsible Party):
University of Alberta
ClinicalTrials.gov Identifier:
NCT01522027
First received: January 26, 2012
Last updated: January 28, 2014
Last verified: August 2012
  Purpose

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.


Condition Intervention
Percutaneous Tracheostomy
Procedure: Percutaneous tracheostomy

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Official Title: Use of Nerve Stimulation Technology to Aid in Percutaneous Tracheostomy in Intensive Care Patients.

Further study details as provided by University of Alberta:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 20
Study Start Date: May 2012
Estimated Study Completion Date: March 2015
Estimated Primary Completion Date: September 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Nerve stimulator
Twenty ICU patients will receive percutaneous tracheostomy via insertion of a needle/catheter connected to a nerve stimulator.
Procedure: Percutaneous tracheostomy
Twenty ICU patients will receive percutaneous tracheostomy via insertion of a needle/catheter connected to a nerve stimulator.

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Adult (> 18 yrs)
  • 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.
  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: NCT01522027

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

Locations
Canada, Alberta
University of Alberta Hospital Recruiting
Edmonton, Alberta, Canada, T6G 2B7
Principal Investigator: Ban Tsui, MD, MSc         
Sub-Investigator: Michael Jacka, MD, MSc         
Sub-Investigator: Gareth Corry, PhD         
Sponsors and Collaborators
University of Alberta
Investigators
Principal Investigator: Ban Tsui, MD, MSc University of Alberta
  More Information

No publications provided

Responsible Party: University of Alberta
ClinicalTrials.gov Identifier: NCT01522027     History of Changes
Other Study ID Numbers: Pro000026880
Study First Received: January 26, 2012
Last Updated: January 28, 2014
Health Authority: Canada: Ethics Review Committee

ClinicalTrials.gov processed this record on November 24, 2014