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

Traumatic Brain Injury Clinical Trial

— INDEXTBI  

Official title:

Evaluation of Integrated Predictive Index of Weaning From Mechanical Ventilation in Patients With Traumatic Brain Injury

Clinical Trial Details — Status: Unknown status

Administrative data

• NCT number: NCT01713010
• Other study ID #: 11212PSC002
• Status: Unknown status
• Phase: N/A
• First received: October 22, 2012
• Last updated: October 24, 2012
• Start date: March 2012
• Est. completion date: December 2012

Study information

• Verified date: October 2012
• Source: Federal University of Uberlandia
• Contact: camila marques dias
• Phone: 55 34 33388655
• Email: camilamd15[@]yahoo.com.br
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Unknown status
• Enrollment: 40
• Est. completion date: December 2012
• Est. primary completion date: December 2012
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Brain Injuries
• Brain Injuries, Traumatic
• Mechanical Ventilation Complication
• Traumatic Brain Injury
• Weaning Failure
• Wounds and Injuries

Intervention

Other:
• Predictive indexes of weaning from mechanical ventilation

Locations

Country	Name	City	State
Brazil	Federal University of Uberlandia	Uberlandia	Minas Gerais

Sponsors (1)

Lead Sponsor	Collaborator
Federal University of Uberlandia

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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