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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT01899352
Other study ID # PCF-TracheoTrial
Secondary ID
Status Not yet recruiting
Phase N/A
First received July 2, 2013
Last updated July 10, 2013
Start date January 2014
Est. completion date January 2017

Study information

Verified date July 2013
Source University of Genova
Contact Paolo Pelosi, MD
Email ppelosi@hotmail.com
Is FDA regulated No
Health authority Italy: Etical Committee, University of Genoa
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

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

Study Design

Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Single Blind (Subject)


Intervention

Procedure:
Tracheostomy
Percutaneous and surgical tracheostomies will be performed with the procedure currently available in clinical practice.

Locations

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

Sponsors (1)

Lead Sponsor Collaborator
University of Genova

Country where clinical trial is conducted

Italy, 

Outcome

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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