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Status unknownNCT02990871Updated Dec 22, 2016

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

An observational study in Brain Injury, Tracheostomy and Neurological Rehabilitation, sponsored by Ospedale Generale Di Zona Moriggia-Pelascini. Status unknown at 1 site in Italy. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2016-12-22.

Sponsored by Ospedale Generale Di Zona Moriggia-Pelascini · Observational

The sponsor has not verified this record recently (last verified Dec 2016), so the status shown — last known as Active, not recruiting — may be out of date.
Study type
Observational
Model
Case-control
Time perspective
Retrospective
Enrollment
80
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Brain Injury
  • Tracheostomy
  • Neurological Rehabilitation

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03

In context

Brain Injuries

2,113 studies on the registry are indexed under Brain Injuries; 385 are open to participants now.

This study's planned enrollment of 80 is below the median of 100 across 690 observational studies indexed under Brain Injuries.

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Lead sponsor

Ospedale Generale Di Zona Moriggia-Pelascini is the lead sponsor of 36 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

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

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

Exclusion Criteria:

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

Observational model
Case-control
Time perspective
Retrospective
Enrollment
80 participants (estimated)
Patient registry
No

Groups and cohorts

  • 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

  • Otherearly neurological rehabilitation

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

  • Otherno-early neurological rehabilitation

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

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What researchers measure

Primary outcomes

  1. decannulation time

    number days between tracheostomy positioning and removal

    Time frame: at data collecting, an average of 1 day

Secondary outcomes

  1. length of stay ICU

    number days between admission and discharge from ICU

    Time frame: at data collecting, an average of 1 day

  2. decannulation time in NRiab

    number days between NRehab admission and decannulation

    Time frame: at data collecting, an average of 1 day

  3. Coma Recovery Scale revised score at discharge

    Time frame: at data collecting, an average of 1 day

  4. Glasgow Coma Scale score at discharge

    Time frame: at data collecting, an average of 1 day

  5. Disability Rating Scale Score at discharge

    Time frame: at data collecting, an average of 1 day

  6. Levels of Cognitive Functioning score at discharge

    Time frame: at data collecting, an average of 1 day

07

Study locations

1 site
  • Ospedale Generale di Zona Moriggia Pelascini
    Gravedona ed Uniti, CO 22015, Italy
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 22, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT02990871
Lead sponsor
Ospedale Generale Di Zona Moriggia-Pelascini
Responsible party
Ilaria Zivi (MD, Ospedale Generale Di Zona Moriggia-Pelascini) — Principal investigator
First posted
Dec 13, 2016
Start date
May 2016
Primary completion
Oct 2016
Last update
Dec 22, 2016

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Dec 2016. You cannot join it, but the record below documents what was studied.

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