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

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2016 by University of Genova
Sponsor:
Information provided by (Responsible Party):
Paolo Pelosi, University of Genova
ClinicalTrials.gov Identifier:
NCT01792258
First received: February 6, 2013
Last updated: February 2, 2016
Last verified: February 2016
  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 University of Genova:

Primary Outcome Measures:
  • Safety of percutaneous tracheostomy [ Time Frame: at the beginning and at the end of the procedure ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • 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 ]

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

Ages Eligible for Study:   18 Years to 82 Years   (Adult, Senior)
Genders Eligible for Study:   Both
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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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 
Study First Received: February 6, 2013
Last Updated: February 2, 2016
Health Authority: Italy: Ethics Committee

Keywords provided by 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

ClinicalTrials.gov processed this record on August 22, 2016