We're building a better ClinicalTrials.gov. Check it out and tell us what you think!
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Ultrasound Guided Percutaneous Tracheostomy

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: NCT01502657
Recruitment Status : Completed
First Posted : January 2, 2012
Last Update Posted : January 2, 2012
Sponsor:
Information provided by (Responsible Party):
Pierre-Grégoire Guinot, Centre Hospitalier Universitaire, Amiens

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

Condition or disease Intervention/treatment Phase
Tracheostomy Hemorrhage Tracheostomy Complications Other Tracheostomy Complications Device: Ultrasonography (EnVisor Philips Medical Systems) Not Applicable

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Ultrasound Guided Percutaneous Tracheostomy in the ICU
Study Start Date : September 2010
Actual Primary Completion Date : November 2011
Actual Study Completion Date : December 2011

Intervention Details:
  • Device: Ultrasonography (EnVisor Philips Medical Systems)
    Percutaneous tracheostomy is performed using the dilatational method with ultrasonography guidance;
    Other Names:
    • Echograph is EnVisor Philips
    • N°453561299512 rev A
    • CE0086


Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.



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.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

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): NCT01502657


Locations
Layout table for location information
France
CHU Amiens
Amiens, Somme, France, 80000
Sponsors and Collaborators
Centre Hospitalier Universitaire, Amiens
Investigators
Layout table for investigator information
Principal Investigator: Pierre grégoire Guinot, MD Centre Hospitalier Universitaire, Amiens
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Pierre-Grégoire Guinot, Dr Guinot Pierre grégoire, Centre Hospitalier Universitaire, Amiens
ClinicalTrials.gov Identifier: NCT01502657    
Other Study ID Numbers: PI10-DR-GUINOT
2010-A00901-38 ( Other Identifier: RCB )
First Posted: January 2, 2012    Key Record Dates
Last Update Posted: January 2, 2012
Last Verified: December 2011
Keywords provided by Pierre-Grégoire Guinot, Centre Hospitalier Universitaire, Amiens:
percutaneous tracheostomy
ultrasonography
echography
critical care
Additional relevant MeSH terms:
Layout table for MeSH terms
Hemorrhage
Postoperative Complications
Pathologic Processes