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

Brain Injury Clinical Trial

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02990871
• Other study ID #: tracheostomy_01
• Status: Active, not recruiting
• Phase: N/A
• First received: September 29, 2016
• Last updated: December 20, 2016
• Start date: May 2016

Study information

• Verified date: December 2016
• Source: Ospedale Generale Di Zona Moriggia-Pelascini
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: Ethics Committee
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 80
• Est. primary completion date: October 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Observational Model: Case Control, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Brain Injuries
• Brain Injury
• Neurological Rehabilitation
• Tracheostomy

Intervention

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

Locations

Country	Name	City	State
Italy	Ospedale Generale di Zona Moriggia Pelascini	Gravedona ed Uniti	CO

Sponsors (1)

Lead Sponsor	Collaborator
Ospedale Generale Di Zona Moriggia-Pelascini

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	decannulation time	number days between tracheostomy positioning and removal	at data collecting, an average of 1 day	No
Secondary	length of stay ICU	number days between admission and discharge from ICU	at data collecting, an average of 1 day	No
Secondary	decannulation time in NRiab	number days between NRehab admission and decannulation	at data collecting, an average of 1 day	No
Secondary	Coma Recovery Scale revised score at discharge		at data collecting, an average of 1 day	No
Secondary	Glasgow Coma Scale score at discharge		at data collecting, an average of 1 day	No
Secondary	Disability Rating Scale Score at discharge		at data collecting, an average of 1 day	No
Secondary	Levels of Cognitive Functioning score at discharge		at data collecting, an average of 1 day	No