MedDataX Logo

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

NCT ID: NCT02990871

Last Updated: 2016-12-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Total Enrollment

80 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-05-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Brain Injury Tracheostomy Neurological Rehabilitation

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

CASE_CONTROL

Study Time Perspective

RETROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

early rehabilitation

Patients started rehabilitative treatment during ICU hospitalization

early neurological rehabilitation

Intervention Type OTHER

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

no-early rehabilitation

Patients started rehabilitative treatment after admission in Neuro-rehabilitation department

no-early neurological rehabilitation

Intervention Type OTHER

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

early neurological rehabilitation

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

Intervention Type OTHER

no-early neurological rehabilitation

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

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Ospedale Generale Di Zona Moriggia-Pelascini

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Ilaria Zivi

MD

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Ospedale Generale di Zona Moriggia Pelascini

Gravedona Ed Uniti, CO, Italy

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Italy

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

tracheostomy_01

Identifier Type: -

Identifier Source: org_study_id