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

• Sponsor: Ospedale Generale Di Zona Moriggia-Pelascini (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT02990871
• Collaborator: (none)
• Enrollment: 80
• Location: 1

Study Details

Study Description

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	Phase
Brain Injury; Tracheostomy; Neurological Rehabilitation	Other: early neurological rehabilitation; Other: no-early neurological rehabilitation

Study Design

• Study Type: Observational
• Anticipated Enrollment: 80 participants
• Observational Model: Case-Control
• Time Perspective: Retrospective
• Study Start Date: May 1, 2016
• Actual Primary Completion Date: Oct 1, 2016

Arms and Interventions

Arm	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

Outcome Measures

Primary Outcome Measures

1. decannulation time [at data collecting, an average of 1 day]

   number days between tracheostomy positioning and removal

Secondary Outcome Measures

1. length of stay ICU [at data collecting, an average of 1 day]

   number days between admission and discharge from ICU

2. decannulation time in NRiab [at data collecting, an average of 1 day]

   number days between NRehab admission and decannulation

3. Coma Recovery Scale revised score at discharge [at data collecting, an average of 1 day]

4. Glasgow Coma Scale score at discharge [at data collecting, an average of 1 day]

5. Disability Rating Scale Score at discharge [at data collecting, an average of 1 day]

6. Levels of Cognitive Functioning score at discharge [at data collecting, an average of 1 day]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Ospedale Generale di Zona Moriggia Pelascini	Gravedona ed Uniti	CO	Italy	22015

Sponsors and Collaborators

• Ospedale Generale Di Zona Moriggia-Pelascini

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Ilaria Zivi, MD, Ospedale Generale Di Zona Moriggia-Pelascini
• ClinicalTrials.gov Identifier: NCT02990871
• Other Study ID Numbers: tracheostomy_01
• First Posted: Dec 13, 2016
• Last Update Posted: Dec 22, 2016
• Last Verified: Dec 1, 2016

• Additional relevant MeSH terms: Brain Injuries

Study Results

No Results Posted as of Dec 22, 2016