Heart Failure Clinical Trial
Official title:
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)
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.
Status | Not yet recruiting |
Enrollment | 1000 |
Est. completion date | January 2017 |
Est. primary completion date | December 2016 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years to 85 Years |
Eligibility |
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 |
Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Single Blind (Subject)
Country | Name | City | State |
---|---|---|---|
Italy | Italian Society of Anesthesia, Analgesia, Resuscitation and Intensive Care | Assisi | |
Italy | Italian Society of Anesthesia, Analgesia, Resuscitation and Intensive Care | Assisi | |
Italy | Policlinico Vittoio Emanuele | Catania | |
Italy | Policlinico SS Annunziata | Chieti | |
Italy | Intensive care unit - San Martino-IST | Genoa | |
Italy | IRCCS Azienda Ospedaliera San Martino IST | Genoa | |
Italy | Centro Cardiologico Monzino | Milan | |
Italy | University of Naples "Federico II" | Naples | |
Italy | Ospedale Morgagni-Pierantoni | Rimini | |
Italy | Università Cattolica del Sacro Cuore | Rome | |
Italy | Università di Torino | Turin |
Lead Sponsor | Collaborator |
---|---|
University of Genova |
Italy,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Mortality at ICU discharge | within 2 days after discharge | Yes | |
Secondary | Quality of Life | Quality of life will be evaluated at 3, 6 and 12 months after the discharge from the intensive care unit. | within 2 days after discharge, at 3, 6 and 12 months after tracheostomy | Yes |
Secondary | Laryngeal organ function | Laryngeal organ function will be evaluated at 3, 6 and 12 months after the discharge from intensive care unit. | within 2 days after discharge, at 3, 6 and 12 months after tracheostomy | Yes |
Secondary | Late complications | from day 2 until the discharge | Yes | |
Secondary | Procedural findings of percutaneous tracheostomy | at the beginning and at the end of tracheostomy procedures | Yes | |
Secondary | Early complication | in the first 24 hours from the end of the procedure | Yes |
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