Electrically Guided Needle Insertion: ICU Study

NCT01522027 | Withdrawn

• 1 other identifier: Pro000026880
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Percutaneous Tracheostomy

Outcome Measures

Primary Outcomes (1)

• Speed and accuracy of needle tip placement in the tracheal lumen

  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.

  From positioning of the patient to withdrawal of needle; approximately 5 minutes

Study Arms (1)

Nerve stimulator

EXPERIMENTAL

Twenty ICU patients will receive percutaneous tracheostomy via insertion of a needle/catheter connected to a nerve stimulator.

Procedure: Percutaneous tracheostomy

Interventions

Percutaneous tracheostomy PROCEDURE

Twenty ICU patients will receive percutaneous tracheostomy via insertion of a needle/catheter connected to a nerve stimulator.

Nerve stimulator

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult (\> 18 yrs)
• Requires tracheostomy

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Alberta: lead

Study Sites (1)

University of Alberta Hospital

Edmonton, Alberta, T6G 2B7, Canada

Location

Study Officials

• Ban Tsui, MD, MSc

  University of Alberta

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: January 26, 2012
• First Posted: January 31, 2012
• Study Start: May 1, 2012
• Primary Completion: November 1, 2017
• Study Completion: November 1, 2017
• Last Updated: March 25, 2020

Record last verified: 2014-12

Locations

CA (1)