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

This study is currently recruiting participants.
Verified October 2012 by Federal University of Uberlandia
Sponsor:
Information provided by (Responsible Party):
Camila Marques Dias, Federal University of Uberlandia
ClinicalTrials.gov Identifier:
NCT01713010
First received: October 22, 2012
Last updated: October 24, 2012
Last verified: October 2012
History of Changes
  Purpose

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.


Condition Intervention
Traumatic Brain Injury
Weaning Failure
Mechanical Ventilation Complication
 Other: Predictive indexes of weaning from mechanical ventilation

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Evaluation of Integrated Predictive Index of Weaning From Mechanical Ventilation in Patients With Traumatic Brain Injury

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Federal University of Uberlandia:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 40
Study Start Date: March 2012
Estimated Study Completion Date: December 2012
Estimated Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Intervention Details:
    Other: Predictive indexes of weaning from mechanical ventilation
    Other Names:
    • respiratory frequency to tidal volume (f/VT)
    • airway occlusion pressure(P0.1)
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.

Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01713010

Contacts
Contact: camila marques dias 55 34 33388655 camilamd15@yahoo.com.br

Locations
Brazil
Federal University of Uberlandia Recruiting
Uberlandia, Minas Gerais, Brazil, 38408-100
Contact: Camila Marques Dias     55 34 33388655     camilamd15@yahoo.com.br    
Sponsors and Collaborators
Federal University of Uberlandia
Investigators
Principal Investigator: Camila Marques Dias Federal University of Uberlandia
Study Chair: Célia Regina Lopes Federal University of Uberlandia
  More Information

No publications provided

Responsible Party: Camila Marques Dias, Physiotherapist, Federal University of Uberlandia
ClinicalTrials.gov Identifier: NCT01713010     History of Changes
Other Study ID Numbers: 11212PSC002
Study First Received: October 22, 2012
Last Updated: October 24, 2012
Health Authority: Brazil: National Committee of Ethics in Research

Keywords provided by Federal University of Uberlandia:
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

Additional relevant MeSH terms:
Brain Injuries
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
 Craniocerebral Trauma
Trauma, Nervous System
Wounds and Injuries

ClinicalTrials.gov processed this record on June 18, 2013