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

February 2, 2016 updated by: Paolo Pelosi, University of Genova

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

200

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Italy
      • Genoa, Italy, 16132
        • Recruiting
        • University of Genoa
        • Contact:
        • Principal Investigator:
          • Paolo Pelosi, Professor
        • Sub-Investigator:
          • Maria Vargas, MD
        • Sub-Investigator:
          • Iole Brunetti, md

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 82 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Criticall ill patients requiring percutaneous tracheostomy in intensive care unit

Description

Inclusion Criteria:

  • age >18
  • indication for tracheostomy

Exclusion Criteria:

  • infectious disease of neck

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Safety of percutaneous tracheostomy
Time Frame: at the beginning and at the end of the procedure
at the beginning and at the end of the procedure

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
in the first 24 hours from the end of the procedure
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.
from the 2nd day ofter the procedure until the ICU discharge (expected average of 2 weeks)
Quality of life
Time Frame: at 3, 6 and 12 months after tracheostomy
The investigator will use the EURO-QOL
at 3, 6 and 12 months after tracheostomy
Evaluation of organ function
Time Frame: At 3, 6 , and 12 months after tracheostomy
The investigator will perform a flexible fiberoptic laryngoscopy.
At 3, 6 , and 12 months after tracheostomy
Quality of voice
Time Frame: At 3,6, 12 months after tracheostomy
the investigator will use a KAY elemetrics analyzer.
At 3,6, 12 months after tracheostomy
Mortality
Time Frame: at 3, 6 and 12 months from tracheostomy
at 3, 6 and 12 months from tracheostomy

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Genova

Investigators

  • Principal Investigator: Paolo Pelosi, Università degli Studi di Genova

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2012

Primary Completion (Anticipated)

February 1, 2016

Study Completion (Anticipated)

January 1, 2017

Study Registration Dates

First Submitted

February 6, 2013

First Submitted That Met QC Criteria

February 12, 2013

First Posted (Estimate)

February 15, 2013

Study Record Updates

Last Update Posted (Estimate)

February 3, 2016

Last Update Submitted That Met QC Criteria

February 2, 2016

Last Verified

February 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 53/12

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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