Procedures and Follow-up of Percutaneous Tracheostomy in Intensive Care Unit
Procedures, Complications and Follow-up of Percutaneous Tracheostomies in Intensive Care Unit
1 other identifier
observational
200
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jun 2012
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2012
CompletedFirst Submitted
Initial submission to the registry
February 6, 2013
CompletedFirst Posted
Study publicly available on registry
February 15, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2017
CompletedFebruary 3, 2016
February 1, 2016
3.7 years
February 6, 2013
February 2, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Safety of percutaneous tracheostomy
at the beginning and at the end of the procedure
Secondary Outcomes (6)
Early complications
in the first 24 hours from the end of the procedure
Late complications
from the 2nd day ofter the procedure until the ICU discharge (expected average of 2 weeks)
Quality of life
at 3, 6 and 12 months after tracheostomy
Evaluation of organ function
At 3, 6 , and 12 months after tracheostomy
Quality of voice
At 3,6, 12 months after tracheostomy
- +1 more secondary outcomes
Study Arms (1)
critical ill patients
The investigator will enroll all the critical ill patients undergoing percutaneous tracheostomy performed in ICU
Interventions
Percutaneous tracheostomies will be performed with the kit commercially available in the current clinical practice.
Eligibility Criteria
Criticall ill patients requiring percutaneous tracheostomy in intensive care unit
You may qualify if:
- age \>18
- indication for tracheostomy
You may not qualify if:
- infectious disease of neck
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Genoa
Genoa, Italy, 16132, Italy
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Paolo Pelosi
Universita degli Studi di Genova
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
February 6, 2013
First Posted
February 15, 2013
Study Start
June 1, 2012
Primary Completion
February 1, 2016
Study Completion
January 1, 2017
Last Updated
February 3, 2016
Record last verified: 2016-02