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

NCT02990871 | Unknown

• 1 other identifier: tracheostomy_01
• Study Type: observational
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Brain Injury; Tracheostomy; Neurological Rehabilitation

Outcome Measures

Primary Outcomes (1)

• decannulation time

  number days between tracheostomy positioning and removal

  at data collecting, an average of 1 day

Secondary Outcomes (6)

• length of stay ICU

  at data collecting, an average of 1 day

• decannulation time in NRiab

  at data collecting, an average of 1 day

• 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

Study Arms (2)

early rehabilitation

Patients started rehabilitative treatment during ICU hospitalization

Other: early neurological rehabilitation

no-early rehabilitation

Patients started rehabilitative treatment after admission in Neuro-rehabilitation department

Other: no-early neurological rehabilitation

Interventions

early neurological rehabilitation OTHER

start of neurological rehabilitation between 3rd and 15th day after ABI

early rehabilitation

no-early neurological rehabilitation OTHER

start of neurological rehabilitation between 20th and 90th day after ABI

no-early rehabilitation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with tracheostomy, affected by severe acquired brain injury, hospitalized in our Neurorehabilitation department.

You may qualify if:

• 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,

You may not qualify if:

• tracheostomy performed prior to admission to the ICU
• need for ventilation support.

Sponsors & Collaborators

• Ospedale Generale Di Zona Moriggia-Pelascini: lead

Study Sites (1)

Ospedale Generale di Zona Moriggia Pelascini

Gravedona Ed Uniti, CO, 22015, Italy

Location

MeSH Terms

Conditions

Brain Injuries

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: September 29, 2016
• First Posted: December 13, 2016
• Study Start: May 1, 2016
• Primary Completion: October 1, 2016
• Last Updated: December 22, 2016

Record last verified: 2016-12

Locations

IT (1)