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

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: Traumatic Brain Injury; Mechanical Ventilation Complication; Weaning Failure
• Intervention / Treatment: Other: Predictive indexes 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 Type: Observational
• Enrollment (Anticipated): 40

Contacts and Locations

Study Locations

• Brazil
  • Minas Gerais
    • Uberlandia, Minas Gerais, Brazil, 38408-100
      • Recruiting
      • Federal University of Uberlândia
      • Contact: Camila Marques Dias; Phone Number: 55 34 33388655; Email: camilamd15@yahoo.com.br

Participation Criteria

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

How is the study designed?

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.	8 months

Collaborators and Investigators

• 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

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:; Mechanical Ventilation; Traumatic Brain Injury; Respiration Disorders; Weaning Failure; Rapid Shallow Breathing Index; Keywords provided by Atlantic Health System:; Mechanical ventilation complication
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Brain Injuries; Wounds and Injuries; Brain Injuries, Traumatic
• Other Study ID Numbers: 11212PSC002