Skip to main content
Clinical Trials/NCT01464567
NCT01464567
Completed
Phase 4

Comparison Between Spontaneous Breathing Trials Through Pressure-Support Ventilation or "T" Tube in the Weaning of Mechanical Ventilation in Patients With Chronic Obstructive Pulmonary Disease: A Randomized Controlled Trial

Hospital Nossa Senhora da Conceicao1 site in 1 country190 target enrollmentJanuary 2012

Overview

Phase
Phase 4
Intervention
Not specified
Conditions
Weaning of Mechanical Ventilation
Sponsor
Hospital Nossa Senhora da Conceicao
Enrollment
190
Locations
1
Primary Endpoint
Days Spent on Mechanical Ventilation
Status
Completed
Last Updated
9 years ago

Overview

Brief Summary

Weaning of mechanical ventilation (MV) is an essential part in management of patients with Chronic Obstructive Pulmonary Disease (COPD) when critically ill. The best strategy to be used has not been established.

Objective: To compare the Spontaneous Breathing Trial (SBT) in Pressure Support Ventilation with SBT through "T" tube in weaning of MV in patients with COPD.

Design: Randomized Clinical Trial. Methods: This study will include patients with COPD, admitted to the Intensive Care Unit of Hospital Nossa Senhora da Conceição, undergoing MV for at least 48 hours. When considered by the care team ready for SBT, they will be randomized to one of the following strategies: SBT in Pressure Support or SBT through "T" Tube. The primary endpoint of this study will be the reduction in the days spent on MV. Other outcomes measured will be mortality, extubation and success rate, time to weaning of MV, length of ICU stay and incidence of tracheostomy.

Registry
clinicaltrials.gov
Start Date
January 2012
End Date
May 2016
Last Updated
9 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Jose Augusto Santos Pellegrini

Principal Investigator

Hospital Nossa Senhora da Conceicao

Eligibility Criteria

Inclusion Criteria

  • COPD patients admitted to our ICU for Acute Respiratory Failure, submitted to Mechanical Ventilation for at least 48 hours
  • 18 years or older

Exclusion Criteria

  • Tracheostomy
  • Younger than 18 years
  • Refuse to give informed consent
  • Individuals who are already enrolled in another clinical trial

Outcomes

Primary Outcomes

Days Spent on Mechanical Ventilation

Time Frame: Participants will be followed for the duration of ICU stay, an expected average of 2 weeks

Secondary Outcomes

  • Mortality(Participants will be followed for the duration of hospital stay, an expected average of 4 weeks)
  • Extubation success rate(Participants will be followed for the duration of ICU stay, an expected average of 4 weeks)

Study Sites (1)

Loading locations...

Similar Trials