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

NCT ID: NCT01899352

Last Updated: 2013-07-15

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

Clinical Phase

NA

Total Enrollment

1000 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-01-31

Study Completion Date

2017-01-31

Brief Summary

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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.

Detailed Description

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Conditions

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Respiratory Failure Neurological Disease Heart Failure Airway Management

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Blinding Strategy

SINGLE

Participants

Study Groups

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Tracheostomy

The investigators will enroll all the critical ill patients undergoing tracheostomy performed in intensive care units

Group Type OTHER

Tracheostomy

Intervention Type PROCEDURE

Percutaneous and surgical tracheostomies will be performed with the procedure currently available in clinical practice.

Interventions

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Tracheostomy

Percutaneous and surgical tracheostomies will be performed with the procedure currently available in clinical practice.

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

85 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-head of intensive care unit

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Italian Society of Anesthesia, Analgesia, Resuscitation and Intensive Care

Assisi, Italy, Italy

Site Status

Italian Society of Anesthesia, Analgesia, Resuscitation and Intensive Care

Assisi, Italy, Italy

Site Status

Policlinico Vittoio Emanuele

Catania, Italy, Italy

Site Status

Policlinico SS Annunziata

Chieti, Italy, Italy

Site Status

Intensive care unit - San Martino-IST

Genoa, Italy, Italy

Site Status

IRCCS Azienda Ospedaliera San Martino IST

Genoa, Italy, Italy

Site Status

Centro Cardiologico Monzino

Milan, Italy, Italy

Site Status

University of Naples "Federico II"

Naples, Italy, Italy

Site Status

Ospedale Morgagni-Pierantoni

Rimini, Italy, Italy

Site Status

Università Cattolica del Sacro Cuore

Rome, Italy, Italy

Site Status

Università di Torino

Turin, Italy, Italy

Site Status

Countries

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Italy

Central Contacts

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Paolo Pelosi, MD

Role: CONTACT

Maria Vargas

Role: CONTACT

Facility Contacts

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Giulio Frova

Role: primary

Massimiliano Sorbello

Role: primary

Flavia Petrini

Role: primary

Paolo Pelosi, MD

Role: primary

Maria Vargas, MD

Role: backup

Guido Merli

Role: primary

Maria Vargas, MD

Role: primary

Ruggero Corso, [email protected]

Role: primary

Massimo Antonelli

Role: primary

Marco V Ranieri

Role: primary

References

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Vargas M, Battaglini D, Antonelli M, Corso R, Frova G, Merli G, Petrini F, Ranieri MV, Sorbello M, Di Giacinto I, Terragni P, Brunetti I, Servillo G, Pelosi P. Follow-up short and long-term mortalities of tracheostomized critically ill patients in an Italian multi-center observational study. Sci Rep. 2024 Jan 28;14(1):2319. doi: 10.1038/s41598-024-52785-y.

Reference Type DERIVED
PMID: 38281994 (View on PubMed)

Other Identifiers

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PCF-TracheoTrial

Identifier Type: -

Identifier Source: org_study_id

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