Procedures and Follow-up of Percutaneous Tracheostomy in Intensive Care Unit

• Conditions: Acute Respiratory Failure; Neurological Disease; Heart Failure
• Interventions: Procedure: Percutaneous tracheostomy

• Registration Number: NCT01792258
• Lead Sponsor: University of Genova

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.

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

• Study Start: 2012-06
• Study First Submitted: 2013-02-06
• Study First Submitted QC: 2013-02-12
• Study First Posted: 2013-02-15
• Status Verified: 2016-02
• Primary Completion: 2016-02
• Last Update Submitted: 2016-02-02
• Last Update Posted: 2016-02-03
• Study Completion: 2017-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

• age >18
• indication for tracheostomy

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Exclusion Criteria

• infectious disease of neck

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
critical ill patients	Percutaneous tracheostomy	The investigator will enroll all the critical ill patients undergoing percutaneous tracheostomy performed in ICU

Primary Outcome Measures

Name	Time	Method
Safety of percutaneous tracheostomy	at the beginning and at the end of the procedure

Secondary Outcome Measures

Name	Time	Method
Quality of life	at 3, 6 and 12 months after tracheostomy	The investigator will use the EURO-QOL
Early complications	in the first 24 hours from the end of the procedure	Early complications are:multiple intubation attempts (more than 1), accidental extubation, paratracheal insertion, injuries to blood vessels in the neck, oesophageal injury, accidental decannulation, malposition of the tracheostomy tube, tracheal cuff puncture, multiple punctures (more than 1), surgical conversion and percutaneous tracheostomy failure, minor bleeding (compressible), major bleeding (incompressible), pneumothorax
Mortality	at 3, 6 and 12 months from tracheostomy
Late complications	from the 2nd day ofter the procedure until the ICU discharge (expected average of 2 weeks)	Late complications are: minor bleeding (compressible), major bleeding (incompressible) tracheostomy puncture site infection, subglottic stenosis, fracture of a tracheal cartilage, granuloma.
Evaluation of organ function	At 3, 6 , and 12 months after tracheostomy	The investigator will perform a flexible fiberoptic laryngoscopy.
Quality of voice	At 3,6, 12 months after tracheostomy	the investigator will use a KAY elemetrics analyzer.

Trial Locations

Locations (1)

University of Genoa; 🇮🇹 Genoa, Italy