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ClinicalTrials.gov ID

NCT01899352

Lead Sponsor

University of GenovaOTHER

Overall Status

Unknown status

Study Type

Interventional

Phase

Not Applicable

Enrollment

1,000Estimated

Last Update Posted

Jul 15, 2013Estimated

Start Date

Jan 2014

Primary Completion Date

Dec 2016Estimated

Completion Date

Jan 2017Estimated

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)

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.

• Respiratory Failure
• Neurological Disease
• Heart Failure
• Airway Management

• Tracheostomy

Ages Eligible for Study

Adult (18-64)Older Adult (65+)

Sexes Eligible for Study

All

Accepts Healthy Volunteers

No

Eligibility Criteria

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

Allocation

Non-Randomized

Interventional Model

Single Group Assignment

Masking

Single

Lead Sponsor

University of GenovaOTHER

maxsorbello@gmail.com

flavia.petrini@unich.it

guidomerli@gmail.com

vargas.maria82@gmail.com

m.antonelli@rmunicatt.it

marco.ranieri@unito.it