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

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)

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.

Study Overview

• Status: Unknown
• Conditions: Heart Failure; Respiratory Failure; Airway Management; Neurological Disease
• Intervention / Treatment: Procedure: Tracheostomy

• Study Type: Interventional
• Enrollment (Anticipated): 1000
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Italy
  • Assisi, Italy
    • Italian Society of Anesthesia, Analgesia, Resuscitation and Intensive Care
  • Catania, Italy
    • Policlinico Vittoio Emanuele
  • Chieti, Italy
    • Policlinico SS Annunziata
  • Genoa, Italy, 16132
    • Intensive care unit - San Martino-IST
  • Genoa, Italy, 16132
    • IRCCS Azienda Ospedaliera San Martino IST
  • Milan, Italy
    • Centro Cardiologico Monzino
  • Naples, Italy, 80100
    • University of Naples "Federico II"
  • Rimini, Italy
    • Ospedale Morgagni-Pierantoni
  • Rome, Italy
    • Universita Cattolica del Sacro Cuore
  • Turin, Italy
    • Università di Torino

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: Single

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Tracheostomy; The investigators will enroll all the critical ill patients undergoing tracheostomy performed in intensive care units	Procedure: Tracheostomy; Percutaneous and surgical tracheostomies will be performed with the procedure currently available in clinical practice.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Mortality at ICU discharge	within 2 days after discharge

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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

Collaborators and Investigators

• Sponsor: University of Genova

Study record dates

Study Major Dates

• Study Start: January 1, 2014
• Primary Completion (Anticipated): December 1, 2016
• Study Completion (Anticipated): January 1, 2017

Study Registration Dates

• First Submitted: July 2, 2013
• First Submitted That Met QC Criteria: July 10, 2013
• First Posted (Estimate): July 15, 2013

Study Record Updates

• Last Update Posted (Estimate): July 15, 2013
• Last Update Submitted That Met QC Criteria: July 10, 2013
• Last Verified: July 1, 2013

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Respiration Disorders; Respiratory Insufficiency; Nervous System Diseases
• Other Study ID Numbers: PCF-TracheoTrial