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

October 24, 2012 updated by: Camila Marques Dias, Federal University of Uberlandia

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Anticipated)

40

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
    • Minas Gerais
      • Uberlandia, Minas Gerais, Brazil, 38408-100
        • Recruiting
        • Federal University of Uberlândia
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients admitted to the intensive care unit with brain trauma in the process of weaning from mechanical ventilation.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
8 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Federal University of Uberlandia

Investigators

  • Principal Investigator: Camila Marques Dias, Federal University of Uberlândia
  • Study Chair: Célia Regina Lopes, Federal University of Uberlândia

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2012

Primary Completion (Anticipated)

December 1, 2012

Study Completion (Anticipated)

December 1, 2012

Study Registration Dates

First Submitted

October 22, 2012

First Submitted That Met QC Criteria

October 23, 2012

First Posted (Estimate)

October 24, 2012

Study Record Updates

Last Update Posted (Estimate)

October 25, 2012

Last Update Submitted That Met QC Criteria

October 24, 2012

Last Verified

October 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 11212PSC002

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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