Traumatic Brain InjuryINDEXTBINCT01713010
Study of Variables Related to the Discontinuation of Mechanical Ventilation in Patients With Head Injury
An observational study of Traumatic Brain Injury and Weaning Failure, run by Federal University of Uberlandia at 1 site in Brazil.
Trial summary
The purpose of this study is to evaluate physiological variables to the decision about the appropriate time to discontinuation of mechanical ventilation in patients with traumatic brain injury. It is expected that these variables are effective in predicting the outcome of weaning from mechanical ventilation. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Traumatic Brain Injury, Weaning Failure, Mechanical Ventilation Complication
- What is being tested?
- Predictive indexes of weaning from mechanical ventilation
- How many people
- 40 participants
- Where
- 1 siteBrazil
- Study dates
- Mar 2012to Dec 2012
- 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 admitted to the intensive care unit with brain trauma in the process of weaning from mechanical ventilation.
Who may be able to join
- Traumatic Brain Injury (TBI)
- Patients using artificial airway (intubation and / or tracheostomy)
- Recovery from the acute phase of the disease underlying
- Both sexes
- Ventilation mode pressure support (PSV), pressure support (PS) required to ensure a tidal volume (VT) = 6 to 8 ml / kg
- Age over 18 years
Show all 13Show fewer
- Hemoglobin > 7 g/dL
- Duration of mechanical ventilation longer than 24 hours
- Body temperature < 38 degrees
- pH ≥ 7.30
- PaO2 ≥ 60 mmHg with FiO2 ≤ 0.4 and PEEP ≤ 8 cmH2O
- Glasgow Coma Scale ≥ 8 or tracheostomized
- Sedative agents minimum dosages to to maintain values of 2 or 3 on the Ramsay Scale
Who cannot join
- Admitted to the ICU with artificial airways held in other institutions
- Surgery scheduled for the next 72 hours
- Withdrawal of consent from parents at any stage of the research
Trial locations and contacts
1 site in 1 country.
Brazil1 site, 1 recruiting
- Recruiting
Federal University of Uberlandia
Uberlândia, Minas Gerais, 38408-100
Camila Marques Dias, 55 34 33388655, camilamd15@yahoo.com.br
About this study
Official title: Evaluation of Integrated Predictive Index of Weaning From Mechanical Ventilation in Patients With Traumatic Brain Injury
The purpose of this study is to evaluate physiological variables to the decision about the appropriate time to discontinuation of mechanical ventilation in patients with traumatic brain injury. It is expected that these variables are effective in predicting the outcome of weaning from mechanical ventilation.
Read the detailed description
The aim of this study is to evaluate the effectiveness of integrated pressure index of airway occlusion x index breathing fast and shallow (p 0.1 x f/VT) in predicting success and failure of weaning from mechanical ventilation in patients with traumatic brain injury.
- Being tested
- Predictive indexes of weaning from mechanical ventilation
- Keywords
- Keywords provided by Atlantic Health System:, Rapid Shallow Breathing Index, Mechanical Ventilation, Additional relevant MeSH terms:, Respiration Disorders, Traumatic Brain Injury, Weaning Failure, Mechanical ventilation complication
- Medical subject headings
- Brain Injuries, Traumatic, Respiration Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Predictive indexes of weaning from mechanical ventilationOther
Also called respiratory frequency to tidal volume (f/VT), airway occlusion pressure(P0.1)
What is being measured
The primary outcome is the main question the study is designed to answer.
Result weaning mechanical ventilation in patients with traumatic brain injury,analyzing success and failure of weaning by 0.1 p and f / VT.
Measured: 8 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Oct 2012 (estimated)
- Study startMar 2012
- Primary completionDec 2012 (estimated)
- Study completionDec 2012 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Traumatic 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 only
- Time perspective
- Prospective
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Federal University of Uberlandia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Camila Marques Dias, Federal University of Uberlandia
- Investigators
- Camila Marques Dias, Principal investigator, Federal University of UberlandiaCélia Regina Lopes, Study chair, Federal University of Uberlandia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01713010
- Sponsor's protocol ID
- 11212PSC002
- Acronym
- INDEXTBI
- Status last verified
- Oct 2012
- First submitted
- 22 Oct 2012
- Last updated
- 25 Oct 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 25 Oct 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Integrated Predictive Index of Weaning From Mechanical Ventilation in Patients With Traumatic Brain Injury
- ClinicalTrials.gov ID
- NCT01713010
- Acronym / sponsor ID
- INDEXTBI / 11212PSC002
- Keywords
- Keywords provided by Atlantic Health System:, Rapid Shallow Breathing Index, Mechanical Ventilation, Additional relevant MeSH terms:, Respiration Disorders, Traumatic Brain Injury, Weaning Failure, Mechanical ventilation complication
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Federal University of UberlandiaUniversity, hospital or other
- Study start
- Mar 2012
- Primary completion
- Dec 2012 (estimated)
- Study completion
- Dec 2012 (estimated)
- First posted
- 24 Oct 2012 (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.
The purpose of this study is to evaluate physiological variables to the decision about the appropriate time to discontinuation of mechanical ventilation in patients with traumatic brain injury. It is expected that these variables are effective in predicting the outcome of weaning from mechanical ventilation.
Detailed description
The aim of this study is to evaluate the effectiveness of integrated pressure index of airway occlusion x index breathing fast and shallow (p 0.1 x f/VT) in predicting success and failure of weaning from mechanical ventilation in patients with traumatic brain injury.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients admitted to the intensive care unit with brain trauma in the process of weaning from mechanical ventilation.
Key inclusion criteria (13 listed)
- Traumatic Brain Injury (TBI)
- Patients using artificial airway (intubation and / or tracheostomy)
- Recovery from the acute phase of the disease underlying
- Both sexes
- Ventilation mode pressure support (PSV), pressure support (PS) required to ensure a tidal volume (VT) = 6 to 8 ml / kg
Key exclusion criteria (3 listed)
- Admitted to the ICU with artificial airways held in other institutions
- Surgery scheduled for the next 72 hours
- Withdrawal of consent from parents at any stage of the research
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 |
|---|---|---|
| Predictive indexes of weaning from mechanical ventilationAlso: respiratory frequency to tidal volume (f/VT), airway occlusion pressure(P0.1) | Other | – |
Primary outcome
Result weaning mechanical ventilation in patients with traumatic brain injury,analyzing success and failure of weaning by 0.1 p and f / VT.
Time frame: 8 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Oct 2012.
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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.
Camila Marques Dias principal investigator
Federal University of Uberlandia
Célia Regina Lopes study chair
Federal University of Uberlandia
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 Traumatic Brain Injury and Weaning Failure, run by Federal University of Uberlandia at 1 site in Brazil.
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 13 inclusion and 3 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 25 Oct 2012. 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 Brazil. 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?
Contact camila marques dias (55 34 33388655, camilamd15@yahoo.com.br), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Result weaning mechanical ventilation in patients with traumatic brain injury,analyzing success and failure of weaning by 0.1 p and f / VT. (time frame: 8 months). 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 25 Oct 2012.