Suspended

Procedures, Complications and Follow-up of Percutaneous Tracheostomies in Intensive Care Unit

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What is being collected

Procedure Data

Collected from today forward - Prospective
Procedure
Who is being recruted

Cardiovascular Diseases+1

+ Heart Diseases

+ Heart Failure

From 18 to 82 Years
+3 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Case-Only

Examining characteristics of individuals with a disease in order to identify genetic or environmental factors contributing to the condition.
Observational
Study Start: June 2012
See protocol details

Summary

Principal SponsorUniversity of Genova
Study ContactPaolo Pelosi, professorMore contacts
Last updated: February 3, 2016
Sourced from a government-validated database.Claim as a partner

Study start date: June 1, 2012

Actual date on which the first participant was enrolled.

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.

NCT01792258
Principal SponsorUniversity of Genova
Study ContactPaolo Pelosi, professorMore contacts
Last updated: February 3, 2016
Sourced from a government-validated database.Claim as a partner

Protocol

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

200 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Case-only

These studies focus only on individuals who have a specific disease. Researchers examine patterns—often genetic or environmental—to uncover what might be linked to the condition.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 18 to 82 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Cardiovascular DiseasesHeart DiseasesHeart FailureNervous System Diseases

Criteria

2 inclusion criteria required to participate
age > 18
indication for tracheostomy
1 exclusion criteria prevent from participating
infectious disease of neck

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

One single intervention group is designated in this study

This study does not include a placebo group 

Treatment Groups

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Recruiting

University of Genoa

Genoa, ItalyOpen University of Genoa in Google Maps
SuspendedOne Study Center