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

Hospital Nossa Senhora da Conceicao

Status and phase: Completed; Phase 4

Conditions: Chronic Obstructive Pulmonary Disease; Weaning of Mechanical Ventilation

Treatments: Procedure: "T" Tube Spontaneous Breathing Trial; Procedure: Pressure Support Ventilation

Study type: Interventional

Funder types: Other

Identifiers

NCT01464567

TVEDPOC-001

Details and patient eligibility

About

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.

Enrollment: 190 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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190 participants in 2 patient groups

"T" Tube Spontaneous Breathing Trial

Active Comparator group

Description:

Spontaneous Breathing Trial wuth "T" Tube for 30 minutes.

Treatment:

Procedure: "T" Tube Spontaneous Breathing Trial

Pressure Support Ventilation

Experimental group

Description:

Spontaneous Breathing Trial wuth Ventilation on Pressure-Support mode set at 10cmH2O for 30 minutes

Treatment:

Procedure: Pressure Support Ventilation