We updated the design of this site on December 18, 2017. Learn more.
ClinicalTrials.gov Menu

Electrically Guided Needle Insertion: ICU Study

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. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01522027
Recruitment Status : Unknown
Verified December 2014 by University of Alberta.
Recruitment status was:  Active, not recruiting
First Posted : January 31, 2012
Last Update Posted : December 19, 2014
Information provided by (Responsible Party):

Study Description
Brief 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. 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 or disease Intervention/treatment
Percutaneous Tracheostomy Procedure: Percutaneous tracheostomy

  Show Detailed Description

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Use of Nerve Stimulation Technology to Aid in Percutaneous Tracheostomy in Intensive Care Patients.
Study Start Date : May 2012
Estimated Primary Completion Date : December 2015
Estimated Study Completion Date : July 2016
Arms and Interventions

Arm Intervention/treatment
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.

Outcome Measures

Primary Outcome Measures :
  1. 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 ]
    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.

Eligibility Criteria

Information from the National Library of Medicine

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, Learn About Clinical Studies.

Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

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): NCT01522027

Canada, Alberta
University of Alberta Hospital
Edmonton, Alberta, Canada, T6G 2B7
Sponsors and Collaborators
University of Alberta
Principal Investigator: Ban Tsui, MD, MSc University of Alberta
More Information

Responsible Party: University of Alberta
ClinicalTrials.gov Identifier: NCT01522027     History of Changes
Other Study ID Numbers: Pro000026880
First Posted: January 31, 2012    Key Record Dates
Last Update Posted: December 19, 2014
Last Verified: December 2014