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Clinical Trials/NCT01899352
NCT01899352UnknownNot Applicable

Procedures, Complications and Follow-up of Tracheostomy in Intensive Care Units - a Prospective Study by Italian Society of Anesthesia, Analgesia, Resuscitation and Intensive Care (SIAARTI)

University of Genova10 sites in 1 country1,000 target enrollmentStarted: January 1, 2014Last updated:
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Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Enrollment
1,000
Locations
10
Primary Endpoint
Mortality at ICU discharge
Study OverviewStudy DesignEligibility CriteriaArms & InterventionsOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

Brief Summary

Tracheostomy is worldwide used for critically ill patients. The aim of our study is to assess the mortality, quality of life, laryngeal function, procedures, early and late complications of tracheostomy performed for critically ill patients admitted in intensive care units.

Study Design

Study Type
Interventional
Allocation
Non Randomized
Intervention Model
Single Group
Masking
Single (Participant)

Eligibility Criteria

Ages
18 Years to 85 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • •age > 18 years
  • •indications for tracheostomy

Exclusion Criteria

  • •Infection/inflammation of neck tissue
  • •Previous neck surgery causing abnormal anatomy of the site
  • •Recent surgery of cervical spine

Arms & Interventions

Tracheostomy

Other

The investigators will enroll all the critical ill patients undergoing tracheostomy performed in intensive care units

Intervention: Tracheostomy (Procedure)

Outcomes

Primary Outcomes

Mortality at ICU discharge

Time Frame: within 2 days after discharge

Secondary Outcomes

  • Quality of Life(within 2 days after discharge, at 3, 6 and 12 months after tracheostomy)
  • Laryngeal organ function(within 2 days after discharge, at 3, 6 and 12 months after tracheostomy)
  • Late complications(from day 2 until the discharge)
  • Procedural findings of percutaneous tracheostomy(at the beginning and at the end of tracheostomy procedures)
  • Early complication(in the first 24 hours from the end of the procedure)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Paolo Pelosi

Professor-head of intensive care unit

University of Genova

Study Sites (10)

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