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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
  Purpose
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.

Condition Intervention
Acute Respiratory Failure Neurological Disease Heart Failure Procedure: Percutaneous tracheostomy

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Procedures, Complications and Follow-up of Percutaneous Tracheostomies in Intensive Care Unit

Resource links provided by NLM:


Further study details as provided by Paolo Pelosi, University of Genova:

Primary Outcome Measures:
  • Safety of percutaneous tracheostomy [ Time Frame: at the beginning and at the end of the procedure ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 200
Study Start Date: June 2012
Estimated Study Completion Date: January 2017
Estimated Primary Completion Date: February 2016 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
critical ill patients
The investigator will enroll all the critical ill patients undergoing percutaneous tracheostomy performed in ICU
Procedure: Percutaneous tracheostomy
Percutaneous tracheostomies will be performed with the kit commercially available in the current clinical practice.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 82 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Criticall ill patients requiring percutaneous tracheostomy in intensive care unit
Criteria

Inclusion Criteria:

  • age >18
  • indication for tracheostomy

Exclusion Criteria:

  • infectious disease of neck
  Contacts and Locations
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): NCT01792258


Contacts
Contact: Paolo Pelosi, professor +39 010 5553136 ppelosi@hotmail.com

Locations
Italy
University of Genoa Recruiting
Genoa, Italy, 16132
Contact: Paolo Pelosi, professor    +39 010 555 3136    ppelosi@hotmail.com   
Principal Investigator: Paolo Pelosi, professor         
Sub-Investigator: Maria Vargas, MD         
Sub-Investigator: Iole Brunetti, md         
Sponsors and Collaborators
University of Genova
Investigators
Principal Investigator: Paolo Pelosi University of Genoa
  More Information

Responsible Party: Paolo Pelosi, Professor, University of Genova
ClinicalTrials.gov Identifier: NCT01792258     History of Changes
Other Study ID Numbers: 53/12
First Submitted: February 6, 2013
First Posted: February 15, 2013
Last Update Posted: February 3, 2016
Last Verified: February 2016

Keywords provided by Paolo Pelosi, University of Genova:
Percutaneous tracheostomy
Intensive Care Unit
Ineffective Airway Clearance
Weaning failure

Additional relevant MeSH terms:
Heart Failure
Respiratory Insufficiency
Respiratory Distress Syndrome, Adult
Nervous System Diseases
Heart Diseases
Cardiovascular Diseases
Respiration Disorders
Respiratory Tract Diseases
Lung Diseases