NCT01899352

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
1,000

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2014

Typical duration for not_applicable

Geographic Reach
1 country

11 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 2, 2013

Completed
13 days until next milestone

First Posted

Study publicly available on registry

July 15, 2013

Completed
6 months until next milestone

Study Start

First participant enrolled

January 1, 2014

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2016

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2017

Completed
Last Updated

July 15, 2013

Status Verified

July 1, 2013

Enrollment Period

2.9 years

First QC Date

July 2, 2013

Last Update Submit

July 10, 2013

Conditions

Respiratory FailureNeurological DiseaseHeart FailureAirway Management

Outcome Measures

Primary Outcomes (1)

  • Mortality at ICU discharge

    within 2 days after discharge

Secondary Outcomes (5)

  • Quality of Life

    within 2 days after discharge, at 3, 6 and 12 months after tracheostomy

  • Laryngeal organ function

    within 2 days after discharge, at 3, 6 and 12 months after tracheostomy

  • Late complications

    from day 2 until the discharge

  • Procedural findings of percutaneous tracheostomy

    at the beginning and at the end of tracheostomy procedures

  • Early complication

    in the first 24 hours from the end of the procedure

Study Arms (1)

Tracheostomy

OTHER

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

Procedure: Tracheostomy

Interventions

TracheostomyPROCEDURE

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

Tracheostomy

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • age \> 18 years
  • indications for tracheostomy

You may not qualify if:

  • Infection/inflammation of neck tissue
  • Previous neck surgery causing abnormal anatomy of the site
  • Recent surgery of cervical spine

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (11)

Italian Society of Anesthesia, Analgesia, Resuscitation and Intensive Care

Assisi, Italy, Italy

Location

Italian Society of Anesthesia, Analgesia, Resuscitation and Intensive Care

Assisi, Italy, Italy

Location

Policlinico Vittoio Emanuele

Catania, Italy, Italy

Location

Policlinico SS Annunziata

Chieti, Italy, Italy

Location

Intensive care unit - San Martino-IST

Genoa, Italy, 16132, Italy

Location

IRCCS Azienda Ospedaliera San Martino IST

Genoa, Italy, 16132, Italy

Location

Centro Cardiologico Monzino

Milan, Italy, Italy

Location

University of Naples "Federico II"

Naples, Italy, 80100, Italy

Location

Ospedale Morgagni-Pierantoni

Rimini, Italy, Italy

Location

Università Cattolica del Sacro Cuore

Rome, Italy, Italy

Location

Università di Torino

Turin, Italy, Italy

Location

Related Publications (1)

  • 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.

    PMID: 38281994DERIVED

MeSH Terms

Conditions

Respiratory InsufficiencyNervous System DiseasesHeart Failure

Interventions

Tracheostomy

Condition Hierarchy (Ancestors)

Respiration DisordersRespiratory Tract DiseasesHeart DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

Airway ManagementTherapeuticsOstomySurgical Procedures, OperativeOtorhinolaryngologic Surgical ProceduresThoracic Surgical Procedures

Central Study Contacts

Paolo Pelosi, MD

CONTACT

ppelosi@hotmail.com

Maria Vargas

CONTACT

vargas.maria82@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor-head of intensive care unit

Study Record Dates

First Submitted

July 2, 2013

First Posted

July 15, 2013

Study Start

January 1, 2014

Primary Completion

December 1, 2016

Study Completion

January 1, 2017

Last Updated

July 15, 2013

Record last verified: 2013-07

Locations

IT(11)