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

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2015 by Hospital Nossa Senhora da Conceicao
Information provided by (Responsible Party):
Jose Augusto Santos Pellegrini, Hospital Nossa Senhora da Conceicao
ClinicalTrials.gov Identifier:
First received: October 24, 2011
Last updated: May 29, 2015
Last verified: May 2015

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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:

Further study details as provided by Hospital Nossa Senhora da Conceicao:

Primary Outcome Measures:
  • Days Spent on Mechanical Ventilation [ Time Frame: Participants will be followed for the duration of ICU stay, an expected average of 2 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Mortality [ Time Frame: Participants will be followed for the duration of hospital stay, an expected average of 4 weeks ] [ Designated as safety issue: No ]
  • Extubation success rate [ Time Frame: Participants will be followed for the duration of ICU stay, an expected average of 4 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 190
Study Start Date: January 2012
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: September 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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


Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01464567

Contact: José Augusto S Pellegrini 55 51 99588389 gutopell@yahoo.com.br

Hospital Nossa Senhora da Conceição Recruiting
Porto Alegre, Rio Grande do Sul, Brazil, 91350-200
Contact    5199588389    gutopell@yahoo.com.br   
Principal Investigator: José Augusto S Pellegrini, M.D.         
Hospital Nossa Senhora da Conceição Recruiting
Porto Alegre, RS, Brazil
Contact: José Augusto Pellegrini    99588389    gutopell@yahoo.com.br   
Contact: Jose Pellegrini    99588389    gutopell@yahoo.com.br   
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 
Study First Received: October 24, 2011
Last Updated: May 29, 2015
Health Authority: Brazil: Ethics Committee

Keywords provided by 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 Tract Diseases

ClinicalTrials.gov processed this record on May 22, 2016