Procedures and Follow-up of Percutaneous Tracheostomy in Intensive Care Unit
|ClinicalTrials.gov Identifier: NCT01792258|
Recruitment Status : Unknown
Verified February 2016 by Paolo Pelosi, University of Genova.
Recruitment status was: Recruiting
First Posted : February 15, 2013
Last Update Posted : February 3, 2016
|Condition or disease||Intervention/treatment|
|Acute Respiratory Failure Neurological Disease Heart Failure||Procedure: Percutaneous tracheostomy|
|Study Type :||Observational|
|Estimated Enrollment :||200 participants|
|Official Title:||Procedures, Complications and Follow-up of Percutaneous Tracheostomies in Intensive Care Unit|
|Study Start Date :||June 2012|
|Estimated Primary Completion Date :||February 2016|
|Estimated Study Completion Date :||January 2017|
critical ill patients
The investigator will enroll all the critical ill patients undergoing percutaneous tracheostomy performed in ICU
Procedure: Percutaneous tracheostomy
Percutaneous tracheostomies will be performed with the kit commercially available in the current clinical practice.
- Safety of percutaneous tracheostomy [ Time Frame: at the beginning and at the end of the procedure ]
- Early complications [ Time Frame: in the first 24 hours from the end of the procedure ]Early complications are:multiple intubation attempts (more than 1), accidental extubation, paratracheal insertion, injuries to blood vessels in the neck, oesophageal injury, accidental decannulation, malposition of the tracheostomy tube, tracheal cuff puncture, multiple punctures (more than 1), surgical conversion and percutaneous tracheostomy failure, minor bleeding (compressible), major bleeding (incompressible), pneumothorax
- Late complications [ Time Frame: from the 2nd day ofter the procedure until the ICU discharge (expected average of 2 weeks) ]Late complications are: minor bleeding (compressible), major bleeding (incompressible) tracheostomy puncture site infection, subglottic stenosis, fracture of a tracheal cartilage, granuloma.
- Quality of life [ Time Frame: at 3, 6 and 12 months after tracheostomy ]The investigator will use the EURO-QOL
- Evaluation of organ function [ Time Frame: At 3, 6 , and 12 months after tracheostomy ]The investigator will perform a flexible fiberoptic laryngoscopy.
- Quality of voice [ Time Frame: At 3,6, 12 months after tracheostomy ]the investigator will use a KAY elemetrics analyzer.
- Mortality [ Time Frame: at 3, 6 and 12 months from tracheostomy ]
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): NCT01792258
|Contact: Paolo Pelosi, professor||+39 010 email@example.com|
|University of Genoa||Recruiting|
|Genoa, Italy, 16132|
|Contact: Paolo Pelosi, professor +39 010 555 3136 firstname.lastname@example.org|
|Principal Investigator: Paolo Pelosi, professor|
|Sub-Investigator: Maria Vargas, MD|
|Sub-Investigator: Iole Brunetti, md|
|Principal Investigator:||Paolo Pelosi||University of Genoa|