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

Phase 4

Completed

• Conditions: Weaning of Mechanical Ventilation; Chronic Obstructive Pulmonary Disease
• Interventions: Procedure: "T" Tube Spontaneous Breathing Trial; Procedure: Pressure Support Ventilation

• Registration Number: NCT01464567
• Lead Sponsor: Hospital Nossa Senhora da Conceicao

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2011-10-24
• Study First Submitted QC: 2011-11-02
• Study First Posted: 2011-11-03
• Study Start: 2012-01
• Primary Completion: 2016-05
• Study Completion: 2016-05
• Status Verified: 2016-11
• Last Update Submitted: 2016-11-23
• Last Update Posted: 2016-11-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 190

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
"T" Tube Spontaneous Breathing Trial	"T" Tube Spontaneous Breathing Trial	Spontaneous Breathing Trial wuth "T" Tube for 30 minutes.
Pressure Support Ventilation	Pressure Support Ventilation	Spontaneous Breathing Trial wuth Ventilation on Pressure-Support mode set at 10cmH2O for 30 minutes

Primary Outcome Measures

Name	Time	Method
Days Spent on Mechanical Ventilation	Participants will be followed for the duration of ICU stay, an expected average of 2 weeks

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Hospital Nossa Senhora da Conceição; 🇧🇷 Porto Alegre, RS, Brazil