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Completed

NCT Number: NCT01464567

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

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.

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Key information

Conditions

Weaning of Mechanical Ventilation Chronic Disease Chronic Obstructive Pulmonary Disease Disease Attributes Lung Diseases Lung Diseases, Obstructive Pathologic Processes Pathological Conditions, Signs and Symptoms Pulmonary Disease, Chronic Obstructive Respiratory Tract Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Hospital Nossa Senhora da Conceição, Porto Alegre, Rio Grande do Sul, Brazil

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

"T" Tube Spontaneous Breathing Trial

Procedure

"T" Tube ventilation for 30 minutes

pressure support ventilation

Procedure

Pressure-Support Ventilation for 30 minutes

Primary outcomes

  1. Days Spent on Mechanical Ventilation

    Time frame: Participants will be followed for the duration of ICU stay, an expected average of 2 weeks

Secondary outcomes

  1. Mortality

    Time frame: Participants will be followed for the duration of hospital stay, an expected average of 4 weeks

  2. Extubation success rate

    Time frame: Participants will be followed for the duration of ICU stay, an expected average of 4 weeks

Sponsors and collaborators

Lead sponsor

Hospital Nossa Senhora da Conceicao

Other

Registry information

Official study title

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

Important dates

Study start
2012
Primary completion
2016
Study completion
2016
First posted
Nov 3, 2011
Registry last updated
Nov 25, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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