Procedures, Complications and Follow-up of Tracheostomy in Intensive Care Units.

Not Applicable

• Conditions: Respiratory Failure; Neurological Disease; Heart Failure; Airway Management
• Interventions: Procedure: Tracheostomy

• Registration Number: NCT01899352
• Lead Sponsor: University of Genova

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Status Verified: 2013-07
• Study First Submitted: 2013-07-02
• Study First Submitted QC: 2013-07-10
• Last Update Submitted: 2013-07-10
• Study First Posted: 2013-07-15
• Last Update Posted: 2013-07-15
• Study Start: 2014-01
• Primary Completion: 2016-12
• Study Completion: 2017-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 1000

Inclusion Criteria

• age > 18 years
• indications for tracheostomy

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Exclusion Criteria

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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Mortality at ICU discharge	within 2 days after discharge

Secondary Outcome Measures

Name	Time	Method
Quality of Life	within 2 days after discharge, at 3, 6 and 12 months after tracheostomy	Quality of life will be evaluated at 3, 6 and 12 months after the discharge from the intensive care unit.
Laryngeal organ function	within 2 days after discharge, at 3, 6 and 12 months after tracheostomy	Laryngeal organ function will be evaluated at 3, 6 and 12 months after the discharge from intensive care unit.
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

Trial Locations

Locations (10)

Centro Cardiologico Monzino; 🇮🇹 Milan, Italy

University of Naples "Federico II"; 🇮🇹 Naples, Italy

Ospedale Morgagni-Pierantoni; 🇮🇹 Rimini, Italy

Università Cattolica del Sacro Cuore; 🇮🇹 Rome, Italy

Policlinico Vittoio Emanuele; 🇮🇹 Catania, Italy

Italian Society of Anesthesia, Analgesia, Resuscitation and Intensive Care; 🇮🇹 Assisi, Italy

Policlinico SS Annunziata; 🇮🇹 Chieti, Italy

Intensive care unit - San Martino-IST; 🇮🇹 Genoa, Italy

IRCCS Azienda Ospedaliera San Martino IST; 🇮🇹 Genoa, Italy

Università di Torino; 🇮🇹 Turin, Italy