Ultrasound Guided Percutaneous Tracheostomy

December 30, 2011 updated by: Pierre-Grégoire Guinot, Centre Hospitalier Universitaire, Amiens

Ultrasound Guided Percutaneous Tracheostomy in the ICU

The purpose of this study is to determine the feasibility and the safety of ultrasound guided percutaneous dilatational tracheostomy.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Percutaneous tracheostomy is commonly performed in critical care units when ventilatory weaning fails or when prolonged mechanical ventilation is required. Numerous complications have been described since the widespread use of Percutaneous Tracheostomy (PCT). Bronchoscopy-guided percutaneous tracheostomy was developed in this context. However, bronchoscopy cannot identify vascular structures and the thyroid gland in the neck, and therefore cannot prevent complications related to organ lesions in the neck. Several studies have demonstrated the value of ultrasound guidance in the neck before performing PCT. No studies have demonstrated the feasibility and the safety of ultrasound guidance for PCT. Ultrasound could improve the understanding of neck anatomy, prevents vascular puncture, and helps guide insertion of the tracheostomy tube.

Study Type

Interventional

Enrollment (Actual)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
    • Somme
      • Amiens, Somme, France, 80000
        • CHU Amiens

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • patients hospitalized in ICU in whom percutaneous tracheostomy is indicated,
  • patients aged > 18 years old,

Exclusion Criteria:

  • age less than 18 years,
  • clotting disorder,
  • infection at the puncture site,
  • emergency tracheostomy

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: SUPPORTIVE_CARE
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Procedure related complications
Time Frame: At the end of the procedure, then participants will be followed for the duration of hospital stay, an expected average of 6 weeks
Complications are: paratracheal insertion, injuries to blood vessels in the neck, oesophageal injury, accidental decannulation, malposition of the tracheostomy tube, tracheal cuff puncture, multiple punctures (more than 3), surgical conversion and percutaneous tracheostomy failure, bleeding (compressible, incompressible, requiring administration of labile blood products), pneumothorax, pneumomediastinum, tracheostomy puncture site infection, surgical conversion, subglottic stenosis, fracture of a tracheal cartilage, granuloma.
At the end of the procedure, then participants will be followed for the duration of hospital stay, an expected average of 6 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Procedure time
Time Frame: The time will be calculated at the end of the procedure; an average of 30 minutes
The total time consisted of a first phase of ulstrasound examination of the cervical region and an implementation phase under ultrasound of percutaneous tracheostomy.
The time will be calculated at the end of the procedure; an average of 30 minutes

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre Hospitalier Universitaire, Amiens

Investigators

  • Principal Investigator: Pierre grégoire Guinot, MD, Centre Hospitalier Universitaire, Amiens

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2010

Primary Completion (ACTUAL)

November 1, 2011

Study Completion (ACTUAL)

December 1, 2011

Study Registration Dates

First Submitted

April 21, 2011

First Submitted That Met QC Criteria

December 30, 2011

First Posted (ESTIMATE)

January 2, 2012

Study Record Updates

Last Update Posted (ESTIMATE)

January 2, 2012

Last Update Submitted That Met QC Criteria

December 30, 2011

Last Verified

December 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PI10-DR-GUINOT
  • 2010-A00901-38 (OTHER: RCB)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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