Procedures and Follow-up of Percutaneous Tracheostomy in Intensive Care Unit

NCT ID: NCT01792258

Last Updated: 2016-02-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

200 participants

Study Classification

OBSERVATIONAL

Study Start Date

2012-06-30

Study Completion Date

2017-01-31

Brief Summary

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Tracheostomy is worldwide performed in Intensive Care Unit (ICU). According to the current literature, indication for percutaneous tracheostomy (PDT) in ICU are: difficult prolonged weaning, prolonged mechanical ventilation, loss of airway reflex, copious secretions, upper airway obstruction. Many studies have focused on the comparison between different PDT techniques and complication. The aim of our study is to evaluate the procedural features, complications, ICU mortality, quality of life, post-discharge mortality of patients undergoing different PDT techniques performed in ICU.

Detailed Description

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Conditions

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Acute Respiratory Failure Neurological Disease Heart Failure

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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critical ill patients

The investigator will enroll all the critical ill patients undergoing percutaneous tracheostomy performed in ICU

Percutaneous tracheostomy

Intervention Type PROCEDURE

Percutaneous tracheostomies will be performed with the kit commercially available in the current clinical practice.

Interventions

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Percutaneous tracheostomy

Percutaneous tracheostomies will be performed with the kit commercially available in the current clinical practice.

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* age \>18
* indication for tracheostomy

Exclusion Criteria

* infectious disease of neck
Minimum Eligible Age

18 Years

Maximum Eligible Age

82 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Genova

OTHER

Sponsor Role lead

Responsible Party

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Paolo Pelosi

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Paolo Pelosi

Role: PRINCIPAL_INVESTIGATOR

Universita degli Studi di Genova

Locations

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University of Genoa

Genoa, Italy, Italy

Site Status RECRUITING

Countries

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Italy

Central Contacts

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Paolo Pelosi, professor

Role: CONTACT

+39 010 5553136

Facility Contacts

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Paolo Pelosi, professor

Role: primary

+39 010 555 3136

Other Identifiers

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53/12

Identifier Type: -

Identifier Source: org_study_id

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