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

NCT02990871 — Unknown, 80 participants, Ospedale Generale Di Zona Moriggia-Pelascini

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Registry	NCT02990871
Status	Unknown
Study type	Observational
Enrollment	80 (Estimated)
Sponsor	Ospedale Generale Di Zona Moriggia-Pelascini (Other)
Conditions	Brain Injury, Tracheostomy, Neurological Rehabilitation
Interventions	early neurological rehabilitation, no-early neurological rehabilitation (Other)
Dates	start 2016-05-01, primary completion 2016-10-01, first posted 2016-12-13, last updated 2016-12-22
Locations	1 site in Italy

-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.

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+Arms and interventions

Arm	Type	Interventions	Description
early rehabilitation		Other: early neurological rehabilitation	Patients started rehabilitative treatment during ICU hospitalization
no-early rehabilitation		Other: no-early neurological rehabilitation	Patients started rehabilitative treatment after admission in Neuro-rehabilitation department

early neurological rehabilitation (Other): start of neurological rehabilitation between 3rd and 15th day after ABI
no-early neurological rehabilitation (Other): start of neurological rehabilitation between 20th and 90th day after ABI

+Outcome measures

Primary outcomes

decannulation time [at data collecting, an average of 1 day]: number days between tracheostomy positioning and removal

Secondary outcomes

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

+Eligibility

Sex: All, ages: 18 Years to any

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.

+Locations (1)

Facility	City	Country	Status
Ospedale Generale di Zona Moriggia Pelascini	Gravedona Ed Uniti, CO	Italy