Spontaneous Breathing Trials Using Pressure-Support or T-Tube in Chronic Obstructive Pulmonary Disease Patients Weaning Mechanical Ventilation

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Weaning of Mechanical Ventilation, Chronic Obstructive Pulmonary Disease

Intervention / Treatment
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* Procedure: T Tube Spontaneous Breathing Trial
* Procedure: Pressure Support Ventilation


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: T Tube Spontaneous Breathing Trial<br>Spontaneous Breathing Trial wuth T Tube for 30 minutes. | Procedure: T Tube Spontaneous Breathing Trial<br>* T Tube ventilation for 30 minutes<br>|
| Experimental: Pressure Support Ventilation<br>Spontaneous Breathing Trial wuth Ventilation on Pressure-Support mode set at 10cmH2O for 30 minutes | Procedure: Pressure Support Ventilation<br>* Pressure-Support Ventilation for 30 minutes<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Days Spent on Mechanical Ventilation |  | Participants will be followed for the duration of ICU stay, an expected average of 2 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Weaning, Chronic Obstructive Pulmonary Disease, Spontaneous Breathing Trial