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

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ClinicalTrials.gov Identifier: NCT01464567
Recruitment Status : Completed
First Posted : November 3, 2011
Last Update Posted : November 25, 2016
Information provided by (Responsible Party):

Study Description
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.

Condition or disease Intervention/treatment Phase
Weaning of Mechanical Ventilation Chronic Obstructive Pulmonary Disease Procedure: "T" Tube Spontaneous Breathing Trial Procedure: Pressure Support Ventilation Phase 4

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 190 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official 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
Study Start Date : January 2012
Primary Completion Date : May 2016
Study Completion Date : May 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: COPD Lung Diseases
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Active Comparator: "T" Tube Spontaneous Breathing Trial
Spontaneous Breathing Trial wuth "T" Tube for 30 minutes.
Procedure: "T" Tube Spontaneous Breathing Trial
"T" Tube ventilation for 30 minutes
Experimental: Pressure Support Ventilation
Spontaneous Breathing Trial wuth Ventilation on Pressure-Support mode set at 10cmH2O for 30 minutes
Procedure: Pressure Support Ventilation
Pressure-Support Ventilation for 30 minutes

Outcome Measures

Primary Outcome Measures :
  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 Outcome Measures :
  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 ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01464567

Hospital Nossa Senhora da Conceição
Porto Alegre, Rio Grande do Sul, Brazil, 91350-200
Hospital Nossa Senhora da Conceição
Porto Alegre, RS, Brazil
Sponsors and Collaborators
Hospital Nossa Senhora da Conceicao
More Information

Responsible Party: Jose Augusto Santos Pellegrini, Principal Investigator, Hospital Nossa Senhora da Conceicao
ClinicalTrials.gov Identifier: NCT01464567     History of Changes
Other Study ID Numbers: TVEDPOC-001
First Posted: November 3, 2011    Key Record Dates
Last Update Posted: November 25, 2016
Last Verified: November 2016

Keywords provided by Jose Augusto Santos Pellegrini, Hospital Nossa Senhora da Conceicao:
Chronic Obstructive Pulmonary Disease
Spontaneous Breathing Trial

Additional relevant MeSH terms:
Lung Diseases
Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Respiratory Aspiration
Respiratory Tract Diseases
Respiration Disorders
Pathologic Processes