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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01464567
First Posted: November 3, 2011
Last Update Posted: November 25, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Jose Augusto Santos Pellegrini, Hospital Nossa Senhora da Conceicao
October 24, 2011
November 3, 2011
November 25, 2016
January 2012
May 2016   (Final data collection date for primary outcome measure)
Days Spent on Mechanical Ventilation [ Time Frame: Participants will be followed for the duration of ICU stay, an expected average of 2 weeks ]
Same as current
Complete list of historical versions of study NCT01464567 on ClinicalTrials.gov Archive Site
  • Mortality [ Time Frame: Participants will be followed for the duration of hospital stay, an expected average of 4 weeks ]
  • Extubation success rate [ Time Frame: Participants will be followed for the duration of ICU stay, an expected average of 4 weeks ]
Same as current
Not Provided
Not Provided
 
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

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.

Not Provided
Interventional
Phase 4
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
  • Weaning of Mechanical Ventilation
  • Chronic Obstructive Pulmonary Disease
  • Procedure: "T" Tube Spontaneous Breathing Trial
    "T" Tube ventilation for 30 minutes
  • Procedure: Pressure Support Ventilation
    Pressure-Support Ventilation for 30 minutes
  • Active Comparator: "T" Tube Spontaneous Breathing Trial
    Spontaneous Breathing Trial wuth "T" Tube for 30 minutes.
    Intervention: Procedure: "T" Tube Spontaneous Breathing Trial
  • Experimental: Pressure Support Ventilation
    Spontaneous Breathing Trial wuth Ventilation on Pressure-Support mode set at 10cmH2O for 30 minutes
    Intervention: Procedure: Pressure Support Ventilation
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
190
May 2016
May 2016   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Brazil
 
 
NCT01464567
TVEDPOC-001
Yes
Not Provided
Not Provided
Jose Augusto Santos Pellegrini, Hospital Nossa Senhora da Conceicao
Hospital Nossa Senhora da Conceicao
Not Provided
Not Provided
Hospital Nossa Senhora da Conceicao
November 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP