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Procedures and Follow-up of Percutaneous Tracheostomy in Intensive Care Unit

This study is currently recruiting participants.
Verified February 2016 by Paolo Pelosi, University of Genova
Sponsor:
ClinicalTrials.gov Identifier:
NCT01792258
First Posted: February 15, 2013
Last Update Posted: February 3, 2016
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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Paolo Pelosi, University of Genova
February 6, 2013
February 15, 2013
February 3, 2016
June 2012
February 2016   (Final data collection date for primary outcome measure)
Safety of percutaneous tracheostomy [ Time Frame: at the beginning and at the end of the procedure ]
Same as current
Complete list of historical versions of study NCT01792258 on ClinicalTrials.gov Archive Site
  • Early complications [ Time Frame: in the first 24 hours from the end of the procedure ]
    Early complications are:multiple intubation attempts (more than 1), accidental extubation, 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 1), surgical conversion and percutaneous tracheostomy failure, minor bleeding (compressible), major bleeding (incompressible), pneumothorax
  • Late complications [ Time Frame: from the 2nd day ofter the procedure until the ICU discharge (expected average of 2 weeks) ]
    Late complications are: minor bleeding (compressible), major bleeding (incompressible) tracheostomy puncture site infection, subglottic stenosis, fracture of a tracheal cartilage, granuloma.
  • Quality of life [ Time Frame: at 3, 6 and 12 months after tracheostomy ]
    The investigator will use the EURO-QOL
  • Evaluation of organ function [ Time Frame: At 3, 6 , and 12 months after tracheostomy ]
    The investigator will perform a flexible fiberoptic laryngoscopy.
  • Quality of voice [ Time Frame: At 3,6, 12 months after tracheostomy ]
    the investigator will use a KAY elemetrics analyzer.
  • Mortality [ Time Frame: at 3, 6 and 12 months from tracheostomy ]
Same as current
Not Provided
Not Provided
 
Procedures and Follow-up of Percutaneous Tracheostomy in Intensive Care Unit
Procedures, Complications and Follow-up of Percutaneous Tracheostomies in Intensive Care Unit
Tracheostomy is worldwide performed in Intensive Care Unit (ICU). According to the current literature, indication for percutaneous tracheostomy (PDT) in ICU are: difficult prolonged weaning, prolonged mechanical ventilation, loss of airway reflex, copious secretions, upper airway obstruction. Many studies have focused on the comparison between different PDT techniques and complication. The aim of our study is to evaluate the procedural features, complications, ICU mortality, quality of life, post-discharge mortality of patients undergoing different PDT techniques performed in ICU.
Not Provided
Observational
Observational Model: Case-Only
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample
Criticall ill patients requiring percutaneous tracheostomy in intensive care unit
  • Acute Respiratory Failure
  • Neurological Disease
  • Heart Failure
Procedure: Percutaneous tracheostomy
Percutaneous tracheostomies will be performed with the kit commercially available in the current clinical practice.
critical ill patients
The investigator will enroll all the critical ill patients undergoing percutaneous tracheostomy performed in ICU
Intervention: Procedure: Percutaneous tracheostomy
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
200
January 2017
February 2016   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • age >18
  • indication for tracheostomy

Exclusion Criteria:

  • infectious disease of neck
Sexes Eligible for Study: All
18 Years to 82 Years   (Adult, Senior)
No
Contact: Paolo Pelosi, professor +39 010 5553136 ppelosi@hotmail.com
Italy
 
 
NCT01792258
53/12
Yes
Not Provided
Not Provided
Paolo Pelosi, University of Genova
University of Genova
Not Provided
Principal Investigator: Paolo Pelosi University of Genoa
University of Genova
February 2016