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

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ClinicalTrials.gov Identifier: NCT02990871
Recruitment Status : Unknown
Verified December 2016 by Ilaria Zivi, Ospedale Generale Di Zona Moriggia-Pelascini.
Recruitment status was:  Active, not recruiting
First Posted : December 13, 2016
Last Update Posted : December 22, 2016
Sponsor:
Information provided by (Responsible Party):
Ilaria Zivi, Ospedale Generale Di Zona Moriggia-Pelascini

Brief Summary:
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.

Condition or disease Intervention/treatment
Brain Injury Tracheostomy Neurological Rehabilitation Other: early neurological rehabilitation Other: no-early neurological rehabilitation

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Study Type : Observational
Estimated Enrollment : 80 participants
Observational Model: Case-Control
Time Perspective: Retrospective
Study Start Date : May 2016
Actual Primary Completion Date : October 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Rehabilitation

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




Primary Outcome Measures :
  1. decannulation time [ Time Frame: at data collecting, an average of 1 day ]
    number days between tracheostomy positioning and removal


Secondary Outcome Measures :
  1. length of stay ICU [ Time Frame: at data collecting, an average of 1 day ]
    number days between admission and discharge from ICU

  2. decannulation time in NRiab [ Time Frame: at data collecting, an average of 1 day ]
    number days between NRehab admission and decannulation

  3. Coma Recovery Scale revised score at discharge [ Time Frame: at data collecting, an average of 1 day ]
  4. Glasgow Coma Scale score at discharge [ Time Frame: at data collecting, an average of 1 day ]
  5. Disability Rating Scale Score at discharge [ Time Frame: at data collecting, an average of 1 day ]
  6. Levels of Cognitive Functioning score at discharge [ Time Frame: at data collecting, an average of 1 day ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with tracheostomy, affected by severe acquired brain injury, hospitalized in our Neurorehabilitation department.
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02990871


Locations
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Italy
Ospedale Generale di Zona Moriggia Pelascini
Gravedona ed Uniti, CO, Italy, 22015
Sponsors and Collaborators
Ospedale Generale Di Zona Moriggia-Pelascini
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Responsible Party: Ilaria Zivi, MD, Ospedale Generale Di Zona Moriggia-Pelascini
ClinicalTrials.gov Identifier: NCT02990871    
Other Study ID Numbers: tracheostomy_01
First Posted: December 13, 2016    Key Record Dates
Last Update Posted: December 22, 2016
Last Verified: December 2016
Additional relevant MeSH terms:
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Brain Injuries
Wounds and Injuries
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Craniocerebral Trauma
Trauma, Nervous System