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

Sponsor
University of Genova (Other)
Overall Status
Unknown status
CT.gov ID
NCT01899352
Collaborator
(none)
1,000
Enrollment
11
Locations
1
Arm
36
Duration (Months)
90.9
Patients Per Site
2.5
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Procedure: Tracheostomy
 N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
1000 participants
Allocation:
Non-Randomized
Intervention Model:
Single Group Assignment
Masking:
Single (Participant)
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)
Study Start Date :
Jan 1, 2014
Anticipated Primary Completion Date :
Dec 1, 2016
Anticipated Study Completion Date :
Jan 1, 2017

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

  1. Mortality at ICU discharge [within 2 days after discharge]

Secondary Outcome Measures

  1. Quality of Life [within 2 days after discharge, at 3, 6 and 12 months after tracheostomy]

    Quality of life will be evaluated at 3, 6 and 12 months after the discharge from the intensive care unit.

  2. Laryngeal organ function [within 2 days after discharge, at 3, 6 and 12 months after tracheostomy]

    Laryngeal organ function will be evaluated at 3, 6 and 12 months after the discharge from intensive care unit.

  3. Late complications [from day 2 until the discharge]

  4. Procedural findings of percutaneous tracheostomy [at the beginning and at the end of tracheostomy procedures]

  5. Early complication [in the first 24 hours from the end of the procedure]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 85 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Italian Society of Anesthesia, Analgesia, Resuscitation and Intensive Care Assisi Italy
2 Italian Society of Anesthesia, Analgesia, Resuscitation and Intensive Care Assisi Italy
3 Policlinico Vittoio Emanuele Catania Italy
4 Policlinico SS Annunziata Chieti Italy
5 Intensive care unit - San Martino-IST Genoa Italy 16132
6 IRCCS Azienda Ospedaliera San Martino IST Genoa Italy 16132
7 Centro Cardiologico Monzino Milan Italy
8 University of Naples "Federico II" Naples Italy 80100
9 Ospedale Morgagni-Pierantoni Rimini Italy
10 Università Cattolica del Sacro Cuore Rome Italy
11 Università di Torino Turin Italy

Sponsors and Collaborators

  • University of Genova

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Paolo Pelosi, Professor-head of intensive care unit, University of Genova
ClinicalTrials.gov Identifier:
NCT01899352
Other Study ID Numbers:
  • PCF-TracheoTrial
First Posted:
Jul 15, 2013
Last Update Posted:
Jul 15, 2013
Last Verified:
Jul 1, 2013
Additional relevant MeSH terms:
Respiratory Insufficiency
Nervous System Diseases

Study Results

No Results Posted as of Jul 15, 2013