Brain InjuryNCT02990871
Efficacy of an Early Rehabilitation on Decannulation Time of Patients With Severe Acquired Brain Injury
An observational study of Brain Injury and Tracheostomy, run by Ospedale Generale Di Zona Moriggia-Pelascini at 1 site in Italy.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Brain Injury, Tracheostomy, Neurological Rehabilitation
- What is being tested?
- early neurological rehabilitation and no-early neurological rehabilitation
- How many people
- 80 participants
- Where
- 1 siteItaly
- Study dates
- May 2016to Oct 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with tracheostomy, affected by severe acquired brain injury, hospitalized in our Neurorehabilitation department.
Who may be able to join
- 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,
Who cannot join
- tracheostomy performed prior to admission to the ICU
- need for ventilation support.
Trial locations and contacts
1 site in 1 country.
Italy1 site
Ospedale Generale di Zona Moriggia Pelascini
Gravedona Ed Uniti, CO, 22015
About this study
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
- Being tested
- early neurological rehabilitation, no-early neurological rehabilitation
- Medical subject headings
- Brain Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
early neurological rehabilitationOther
start of neurological rehabilitation between 3rd and 15th day after ABI
no-early neurological rehabilitationOther
start of neurological rehabilitation between 20th and 90th day after ABI
| Study group | Role | What they receive |
|---|---|---|
| early rehabilitation | Patients started rehabilitative treatment during ICU hospitalization Receives: Other: early neurological rehabilitation | |
| no-early rehabilitation | Patients started rehabilitative treatment after admission in Neuro-rehabilitation department Receives: Other: no-early neurological rehabilitation |
What is being measured
The primary outcome is the main question the study is designed to answer.
decannulation time
number days between tracheostomy positioning and removal
Measured: at data collecting, an average of 1 day
Secondary outcomes (6)
length of stay ICU
number days between admission and discharge from ICU
Measured: at data collecting, an average of 1 day
decannulation time in NRiab
number days between NRehab admission and decannulation
Measured: at data collecting, an average of 1 day
Coma Recovery Scale revised score at discharge
Measured: at data collecting, an average of 1 day
Glasgow Coma Scale score at discharge
Measured: at data collecting, an average of 1 day
Disability Rating Scale Score at discharge
Measured: at data collecting, an average of 1 day
Levels of Cognitive Functioning score at discharge
Measured: at data collecting, an average of 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Dec 2016 (estimated)
- Study startMay 2016
- Primary completionOct 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Brain InjuryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ospedale Generale Di Zona Moriggia-Pelascini
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ilaria Zivi, Ospedale Generale Di Zona Moriggia-Pelascini
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02990871
- Sponsor's protocol ID
- tracheostomy_01
- Status last verified
- Dec 2016
- First submitted
- 29 Sep 2016
- Last updated
- 22 Dec 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Dec 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of an Early Rehabilitation on Decannulation Time of Patients With Severe Acquired Brain Injury
- ClinicalTrials.gov ID
- NCT02990871
- Acronym / sponsor ID
- tracheostomy_01
- Conditions
- Brain Injury, Tracheostomy, Neurological Rehabilitation
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Ospedale Generale Di Zona Moriggia-PelasciniUniversity, hospital or other
- Study start
- May 2016
- Primary completion
- Oct 2016 (actual)
- First posted
- 13 Dec 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| early rehabilitation | – | Other: early neurological rehabilitationPatients started rehabilitative treatment during ICU hospitalization |
| no-early rehabilitation | – | Other: no-early neurological rehabilitationPatients started rehabilitative treatment after admission in Neuro-rehabilitation department |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with tracheostomy, affected by severe acquired brain injury, hospitalized in our Neurorehabilitation department.
Key inclusion criteria (4 listed)
- 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,
Key exclusion criteria (2 listed)
- tracheostomy performed prior to admission to the ICU
- need for ventilation support.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| early neurological rehabilitationstart of neurological rehabilitation between 3rd and 15th day after ABI | Other | early rehabilitation |
| no-early neurological rehabilitationstart of neurological rehabilitation between 20th and 90th day after ABI | Other | no-early rehabilitation |
Primary outcome
decannulation time
Time frame: at data collecting, an average of 1 day
number days between tracheostomy positioning and removal
6 secondary outcomes
length of stay ICU
Time frame: at data collecting, an average of 1 day
decannulation time in NRiab
Time frame: at data collecting, an average of 1 day
Coma Recovery Scale revised score at discharge
Time frame: at data collecting, an average of 1 day
Glasgow Coma Scale score at discharge
Time frame: at data collecting, an average of 1 day
Disability Rating Scale Score at discharge
Time frame: at data collecting, an average of 1 day
Levels of Cognitive Functioning score at discharge
Time frame: at data collecting, an average of 1 day
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Dec 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Brain Injury and Tracheostomy, run by Ospedale Generale Di Zona Moriggia-Pelascini at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 22 Dec 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
decannulation time (time frame: at data collecting, an average of 1 day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Dec 2016.