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

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

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01464567

Enrollment

190

Registered

2011-11-03

Start date

2012-01-31

Completion date

2016-05-31

Last updated

2016-11-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Obstructive Pulmonary Disease, Weaning of Mechanical Ventilation

Keywords

Weaning, Chronic Obstructive Pulmonary Disease, Spontaneous Breathing Trial

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.

Interventions

PROCEDURET Tube Spontaneous Breathing Trial

T Tube ventilation for 30 minutes

PROCEDUREPressure Support Ventilation

Pressure-Support Ventilation for 30 minutes

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

SUPPORTIVE_CARE

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Design outcomes

Primary

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

Secondary

Measure	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

Countries

Brazil

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 23, 2026