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

Primary Purpose

Weaning of Mechanical Ventilation, Chronic Obstructive Pulmonary Disease

Status
Completed
Phase
Phase 4
Locations
Brazil
Study Type
Interventional
Intervention
"T" Tube Spontaneous Breathing Trial
Pressure Support Ventilation
Sponsored by
Hospital Nossa Senhora da Conceicao
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Weaning of Mechanical Ventilation focused on measuring Weaning, Chronic Obstructive Pulmonary Disease, Spontaneous Breathing Trial

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Hospital Nossa Senhora da Conceição
  • Hospital Nossa Senhora da Conceição

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

"T" Tube Spontaneous Breathing Trial

Pressure Support Ventilation

Arm Description

Spontaneous Breathing Trial wuth "T" Tube for 30 minutes.

Spontaneous Breathing Trial wuth Ventilation on Pressure-Support mode set at 10cmH2O for 30 minutes

Outcomes

Primary Outcome Measures

Days Spent on Mechanical Ventilation

Secondary Outcome Measures

Mortality
Extubation success rate

Full Information

First Posted
October 24, 2011
Last Updated
November 23, 2016
Sponsor
Hospital Nossa Senhora da Conceicao
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1. Study Identification

Unique Protocol Identification Number
NCT01464567
Brief Title
Spontaneous Breathing Trials Using Pressure-Support or T-Tube in Chronic Obstructive Pulmonary Disease Patients Weaning Mechanical Ventilation
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 Type
Interventional

2. Study Status

Record Verification Date
November 2016
Overall Recruitment Status
Completed
Study Start Date
January 2012 (undefined)
Primary Completion Date
May 2016 (Actual)
Study Completion Date
May 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hospital Nossa Senhora da Conceicao

4. Oversight

Data Monitoring Committee
Yes

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Weaning of Mechanical Ventilation, Chronic Obstructive Pulmonary Disease
Keywords
Weaning, Chronic Obstructive Pulmonary Disease, Spontaneous Breathing Trial

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
190 (Actual)

8. Arms, Groups, and Interventions

Arm Title
"T" Tube Spontaneous Breathing Trial
Arm Type
Active Comparator
Arm Description
Spontaneous Breathing Trial wuth "T" Tube for 30 minutes.
Arm Title
Pressure Support Ventilation
Arm Type
Experimental
Arm Description
Spontaneous Breathing Trial wuth Ventilation on Pressure-Support mode set at 10cmH2O for 30 minutes
Intervention Type
Procedure
Intervention Name(s)
"T" Tube Spontaneous Breathing Trial
Intervention Description
"T" Tube ventilation for 30 minutes
Intervention Type
Procedure
Intervention Name(s)
Pressure Support Ventilation
Intervention Description
Pressure-Support Ventilation for 30 minutes
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
Mortality
Time Frame
Participants will be followed for the duration of hospital stay, an expected average of 4 weeks
Title
Extubation success rate
Time Frame
Participants will be followed for the duration of ICU stay, an expected average of 4 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Hospital Nossa Senhora da Conceição
City
Porto Alegre
State/Province
Rio Grande do Sul
ZIP/Postal Code
91350-200
Country
Brazil
Facility Name
Hospital Nossa Senhora da Conceição
City
Porto Alegre
State/Province
RS
Country
Brazil

12. IPD Sharing Statement

Citations:
PubMed Identifier
30138422
Citation
Santos Pellegrini JA, Boniatti MM, Boniatti VC, Zigiotto C, Viana MV, Nedel WL, Marques LDS, Dos Santos MC, de Almeida CB, Dal' Pizzol CP, Ziegelmann PK, Rios Vieira SR. Pressure-support ventilation or T-piece spontaneous breathing trials for patients with chronic obstructive pulmonary disease - A randomized controlled trial. PLoS One. 2018 Aug 23;13(8):e0202404. doi: 10.1371/journal.pone.0202404. eCollection 2018.
Results Reference
derived

Learn more about this trial

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

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