- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02990871
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
-
-
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
|
start of neurological rehabilitation between 3rd and 15th day after ABI
|
no-early rehabilitation
Patients started rehabilitative treatment after admission in Neuro-rehabilitation department
|
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.
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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