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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01899352
Recruitment Status : Unknown
Verified July 2013 by Paolo Pelosi, University of Genova.
Recruitment status was:  Not yet recruiting
First Posted : July 15, 2013
Last Update Posted : July 15, 2013
Sponsor:
Information provided by (Responsible Party):
Paolo Pelosi, University of Genova

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
Respiratory Failure Neurological Disease Heart Failure Airway Management Procedure: Tracheostomy Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated 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 : January 2014
Estimated Primary Completion Date : December 2016
Estimated Study Completion Date : January 2017

Arm Intervention/treatment
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.




Primary Outcome Measures :
  1. Mortality at ICU discharge [ Time Frame: within 2 days after discharge ]

Secondary Outcome Measures :
  1. Quality of Life [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: from day 2 until the discharge ]
  4. Procedural findings of percutaneous tracheostomy [ Time Frame: at the beginning and at the end of tracheostomy procedures ]
  5. Early complication [ Time Frame: in the first 24 hours from the end of the procedure ]


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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01899352


Contacts
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Contact: Paolo Pelosi, MD ppelosi@hotmail.com
Contact: Maria Vargas vargas.maria82@gmail.com

Locations
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Italy
Italian Society of Anesthesia, Analgesia, Resuscitation and Intensive Care Not yet recruiting
Assisi, Italy
Contact: Giulio Frova       giulio.frova@alice.it   
Principal Investigator: Giulio Frova         
Italian Society of Anesthesia, Analgesia, Resuscitation and Intensive Care
Assisi, Italy
Policlinico Vittoio Emanuele Not yet recruiting
Catania, Italy
Contact: Massimiliano Sorbello       maxsorbello@gmail.com   
Principal Investigator: Massi,iliano Sorbello         
Policlinico SS Annunziata Not yet recruiting
Chieti, Italy
Contact: Flavia Petrini       flavia.petrini@unich.it   
Principal Investigator: Flavia Petrini         
Intensive care unit - San Martino-IST Not yet recruiting
Genoa, Italy, 16132
Contact: Paolo Pelosi, MD       ppelosi@hotmail.com   
Contact: Maria Vargas, MD       vargas.maria82@gmail.com   
Principal Investigator: Paolo Pelosi, MD         
IRCCS Azienda Ospedaliera San Martino IST
Genoa, Italy, 16132
Centro Cardiologico Monzino Not yet recruiting
Milan, Italy
Contact: Guido Merli       guidomerli@gmail.com   
Principal Investigator: Guido Merli         
University of Naples "Federico II" Not yet recruiting
Naples, Italy, 80100
Contact: Maria Vargas, MD       vargas.maria82@gmail.com   
Principal Investigator: Maria Vargas, MD         
Ospedale Morgagni-Pierantoni Not yet recruiting
Rimini, Italy
Contact: Ruggero Corso, rmcorso@gmail.com         
Principal Investigator: Ruggero Corso         
Università Cattolica del Sacro Cuore Not yet recruiting
Rome, Italy
Contact: Massimo Antonelli       m.antonelli@rmunicatt.it   
Principal Investigator: Massimo Antonelli         
Università di Torino Not yet recruiting
Turin, Italy
Contact: Marco V Ranieri       marco.ranieri@unito.it   
Principal Investigator: Pierpaolo Terragni         
Sponsors and Collaborators
University of Genova

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Responsible Party: Paolo Pelosi, Professor-head of intensive care unit, University of Genova
ClinicalTrials.gov Identifier: NCT01899352     History of Changes
Other Study ID Numbers: PCF-TracheoTrial
First Posted: July 15, 2013    Key Record Dates
Last Update Posted: July 15, 2013
Last Verified: July 2013
Additional relevant MeSH terms:
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Respiratory Insufficiency
Nervous System Diseases
Respiration Disorders
Respiratory Tract Diseases