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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: ClinicalTrials.gov
Last refreshed on: 19 February 2015
Main ID:  NCT01502657
Date of registration: 21/04/2011
Prospective Registration: No
Primary sponsor: Centre Hospitalier Universitaire, Amiens
Public title: Ultrasound Guided Percutaneous Tracheostomy
Scientific title: Ultrasound Guided Percutaneous Tracheostomy in the ICU
Date of first enrolment: September 2010
Target sample size: 40
Recruitment status: Completed
URL:  http://clinicaltrials.gov/show/NCT01502657
Study type:  Interventional
Study design:  Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Supportive Care  
Phase:  N/A
Countries of recruitment
France
Contacts
Name:     Pierre grĂ©goire Guinot, MD
Address: 
Telephone:
Email:
Affiliation:  Centre Hospitalier Universitaire, Amiens
Key inclusion & exclusion 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



Age minimum: 18 Years
Age maximum: N/A
Gender: Both
Health Condition(s) or Problem(s) studied
Tracheostomy Hemorrhage
Other Tracheostomy Complications
Tracheostomy Complications
Intervention(s)
Device: Ultrasonography (EnVisor Philips Medical Systems)
Primary Outcome(s)
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]
Secondary Outcome(s)
Procedure time [Time Frame: The time will be calculated at the end of the procedure; an average of 30 minutes]
Secondary ID(s)
PI10-DR-GUINOT
2010-A00901-38
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
Ethics review
Results
Results available:
Date Posted:
Date Completed:
URL:
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