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

• Conditions: Traumatic Brain Injury; Weaning Failure; Mechanical Ventilation Complication

• Registration Number: NCT01713010
• Lead Sponsor: Federal University of Uberlandia

Brief 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.

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 Timeline

• Study Start: 2012-03
• Status Verified: 2012-10
• Study First Submitted: 2012-10-22
• Study First Submitted QC: 2012-10-23
• Study First Posted: 2012-10-24
• Last Update Submitted: 2012-10-24
• Last Update Posted: 2012-10-25
• Primary Completion: 2012-12
• Study Completion: 2012-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 40

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Federal University of Uberlandia; 🇧🇷 Uberlandia, Minas Gerais, Brazil