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

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)

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT01899352
• Other study ID #: PCF-TracheoTrial
• 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)

Related Conditions & MeSH terms

• Airway Management
• Heart Failure
• Nervous System Diseases
• Neurological Disease
• Respiratory Failure
• Respiratory Insufficiency

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