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

Heart Failure Clinical Trial

Official title:

Procedures, Complications and Follow-up of Percutaneous Tracheostomies in Intensive Care Unit

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01792258
• Other study ID #: 53/12
• Status: Recruiting
• Phase: N/A
• First received: February 6, 2013
• Last updated: February 2, 2016
• Start date: June 2012
• Est. completion date: January 2017

Study information

• Verified date: February 2016
• Source: University of Genova
• Contact: Paolo Pelosi, professor
• Phone: +39 010 5553136
• Email: ppelosi[@]hotmail.com
• Is FDA regulated: No
• Health authority: Italy: Ethics Committee
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: January 2017
• Est. primary completion date: February 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 82 Years

Eligibility

Inclusion Criteria:

• age >18

• indication for tracheostomy

Exclusion Criteria:

• infectious disease of neck

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Acute Respiratory Failure
• Heart Failure
• Nervous System Diseases
• Neurological Disease
• Respiratory Distress Syndrome, Adult
• Respiratory Insufficiency

Intervention

Procedure:
• Percutaneous tracheostomy
Percutaneous tracheostomies will be performed with the kit commercially available in the current clinical practice.

Locations

Country	Name	City	State
Italy	University of Genoa	Genoa

Sponsors (1)

Lead Sponsor	Collaborator
University of Genova

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety of percutaneous tracheostomy		at the beginning and at the end of the procedure	Yes
Secondary	Early complications	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	in the first 24 hours from the end of the procedure	Yes
Secondary	Late complications	Late complications are: minor bleeding (compressible), major bleeding (incompressible) tracheostomy puncture site infection, subglottic stenosis, fracture of a tracheal cartilage, granuloma.	from the 2nd day ofter the procedure until the ICU discharge (expected average of 2 weeks)	Yes
Secondary	Quality of life	The investigator will use the EURO-QOL	at 3, 6 and 12 months after tracheostomy	Yes
Secondary	Evaluation of organ function	The investigator will perform a flexible fiberoptic laryngoscopy.	At 3, 6 , and 12 months after tracheostomy	Yes
Secondary	Quality of voice	the investigator will use a KAY elemetrics analyzer.	At 3,6, 12 months after tracheostomy	Yes
Secondary	Mortality		at 3, 6 and 12 months from tracheostomy	Yes