MedDataX Logo

Study of Variables Related to the Discontinuation of Mechanical Ventilation in Patients With Head Injury

NCT ID: NCT01713010

Last Updated: 2012-10-25

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

40 participants

Study Classification

OBSERVATIONAL

Study Start Date

2012-03-31

Study Completion Date

2012-12-31

Brief Summary

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

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

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

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.

Conditions

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

Traumatic Brain Injury Weaning Failure Mechanical Ventilation Complication

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

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 Design

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

Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Interventions

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

Predictive indexes of weaning from mechanical ventilation

Intervention Type OTHER

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

respiratory frequency to tidal volume (f/VT) airway occlusion pressure(P0.1)

Eligibility Criteria

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

Inclusion Criteria

* 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
* 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

Exclusion Criteria

* 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
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.

Federal University of Uberlandia

OTHER

Sponsor Role lead

Responsible Party

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

Camila Marques Dias

Physiotherapist

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Camila Marques Dias

Role: PRINCIPAL_INVESTIGATOR

Federal University of Uberlandia

Célia Regina Lopes

Role: STUDY_CHAIR

Federal University of Uberlandia

Locations

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

Federal University of Uberlandia

Uberlândia, Minas Gerais, Brazil

Site Status RECRUITING

Countries

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

Brazil

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

camila marques dias

Role: CONTACT

Phone: 55 34 33388655

Email: [email protected]

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Camila Marques Dias

Role: primary

Other Identifiers

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

11212PSC002

Identifier Type: -

Identifier Source: org_study_id