Efficacy of an Early Rehabilitation on Decannulation Time of Patients With Severe Acquired Brain Injury

December 20, 2016 updated by: Ilaria Zivi, Ospedale Generale Di Zona Moriggia-Pelascini
All the patients hospitalized in the neuro-rehabilitation after a severe acquired brain injury carrying a tracheal cannula will be retrospectively analyzed. Patients coming from emergency department started a rehabilitative treatment during their hospitalization in ICU. Patients transferred from an external ICU started the rehabilitation in neurorehabilitation department. Aim of the study is to evaluate if an early rehabilitation, started since the acute stage of the damage, is able to reduce the decannulation time in this group of patients.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

80

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
    • CO
      • Gravedona ed Uniti, CO, Italy, 22015
        • Ospedale Generale di Zona Moriggia Pelascini

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients with tracheostomy, affected by severe acquired brain injury, hospitalized in our Neurorehabilitation department.

Description

Inclusion Criteria:

  • presence of a tracheostomy at admission in NRehab
  • patient moved from an ICU
  • GCS≤11 at admission in ICU
  • tracheostomy performed for decreased mental status due to the ABI,

Exclusion Criteria:

  • tracheostomy performed prior to admission to the ICU
  • need for ventilation support.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Control
  • Time Perspectives: Retrospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
early rehabilitation
Patients started rehabilitative treatment during ICU hospitalization
Other: early neurological rehabilitation
start of neurological rehabilitation between 3rd and 15th day after ABI
no-early rehabilitation
Patients started rehabilitative treatment after admission in Neuro-rehabilitation department
Other: no-early neurological rehabilitation
start of neurological rehabilitation between 20th and 90th day after ABI

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
decannulation time
Time Frame: at data collecting, an average of 1 day
number days between tracheostomy positioning and removal
at data collecting, an average of 1 day

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
length of stay ICU
Time Frame: at data collecting, an average of 1 day
number days between admission and discharge from ICU
at data collecting, an average of 1 day
decannulation time in NRiab
Time Frame: at data collecting, an average of 1 day
number days between NRehab admission and decannulation
at data collecting, an average of 1 day
Coma Recovery Scale revised score at discharge
Time Frame: at data collecting, an average of 1 day
at data collecting, an average of 1 day
Glasgow Coma Scale score at discharge
Time Frame: at data collecting, an average of 1 day
at data collecting, an average of 1 day
Disability Rating Scale Score at discharge
Time Frame: at data collecting, an average of 1 day
at data collecting, an average of 1 day
Levels of Cognitive Functioning score at discharge
Time Frame: at data collecting, an average of 1 day
at data collecting, an average of 1 day

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ospedale Generale Di Zona Moriggia-Pelascini

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2016

Primary Completion (Actual)

October 1, 2016

Study Completion

December 6, 2022

Study Registration Dates

First Submitted

September 29, 2016

First Submitted That Met QC Criteria

December 8, 2016

First Posted (Estimate)

December 13, 2016

Study Record Updates

Last Update Posted (Estimate)

December 22, 2016

Last Update Submitted That Met QC Criteria

December 20, 2016

Last Verified

December 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • tracheostomy_01

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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