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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Paolo Pelosi, University of Genova
ClinicalTrials.gov Identifier:
NCT01792258
First received: February 6, 2013
Last updated: February 12, 2013
Last verified: February 2013

February 6, 2013
February 12, 2013
June 2012
June 2013   (final data collection date for primary outcome measure)
Safety of percutaneous tracheostomy [ Time Frame: at the beginning and at the end of the procedure ] [ Designated as safety issue: Yes ]
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 ] [ Designated as safety issue: Yes ]
    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) ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
    The investigator will use the EURO-QOL
  • Evaluation of organ function [ Time Frame: At 3, 6 , and 12 months after tracheostomy ] [ Designated as safety issue: Yes ]
    The investigator will perform a flexible fiberoptic laryngoscopy.
  • Quality of voice [ Time Frame: At 3,6, 12 months after tracheostomy ] [ Designated as safety issue: Yes ]
    the investigator will use a KAY elemetrics analyzer.
  • Mortality [ Time Frame: at 3, 6 and 12 months from tracheostomy ] [ Designated as safety issue: Yes ]
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.
 
Active, not recruiting
200
June 2014
June 2013   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • age >18
  • indication for tracheostomy

Exclusion Criteria:

  • infectious disease of neck
Both
18 Years to 82 Years
No
Contact information is only displayed when the study is recruiting subjects
Italy
 
NCT01792258
53/12
Yes
Paolo Pelosi, University of Genova
University of Genova
Not Provided
Principal Investigator: Paolo Pelosi University of Genoa
University of Genova
February 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP