A Phase 4 interventional study of "T" Tube Spontaneous Breathing Trial and Pressure Support Ventilation in Weaning of Mechanical Ventilation and Chronic Obstructive Pulmonary Disease, sponsored by Hospital Nossa Senhora da Conceicao. Completed at 2 sites in Brazil. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2016-11-25.
Sponsored by Hospital Nossa Senhora da Conceicao · Phase 4, Interventional, and Supportive care
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.
3,303 studies on the registry are indexed under Lung Diseases; 355 are open to participants now.
This study's enrollment of 190 is above the median of 72 across 2,118 interventional studies indexed under Lung Diseases.
Browse Lung Diseases studies →Hospital Nossa Senhora da Conceicao is the lead sponsor of 21 studies on the registry; 5 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Spontaneous Breathing Trial wuth "T" Tube for 30 minutes.
Procedure: "T" Tube Spontaneous Breathing Trial
Spontaneous Breathing Trial wuth Ventilation on Pressure-Support mode set at 10cmH2O for 30 minutes
Procedure: Pressure Support Ventilation
"T" Tube ventilation for 30 minutes
Pressure-Support Ventilation for 30 minutes
Days Spent on Mechanical Ventilation
Time frame: Participants will be followed for the duration of ICU stay, an expected average of 2 weeks
Mortality
Time frame: Participants will be followed for the duration of hospital stay, an expected average of 4 weeks
Extubation success rate
Time frame: Participants will be followed for the duration of ICU stay, an expected average of 4 weeks
This study is completed, as verified in Nov 2016. You cannot join it, but the record below documents what was studied.
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Hospital Nossa Senhora da Conceicao