Spontaneous Breathing Trials Using Pressure-Support or T-Tube in Chronic Obstructive Pulmonary Disease Patients Weaning Mechanical Ventilation
This study is currently recruiting participants.
Verified February 2013 by Hospital Nossa Senhora da Conceicao
Sponsor:
Hospital Nossa Senhora da Conceicao
Information provided by (Responsible Party):
Jose Augusto Santos Pellegrini, Hospital Nossa Senhora da Conceicao
ClinicalTrials.gov Identifier:
NCT01464567
First received: October 24, 2011
Last updated: February 5, 2013
Last verified: February 2013
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose
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: | March 2014 |
| Estimated Primary Completion Date: | January 2014 (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
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01464567
Contacts
| Contact: José Augusto S Pellegrini | 55 51 99588389 | gutopell@yahoo.com.br |
Locations
| Brazil | |
| 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
No publications provided
| 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: | February 5, 2013 |
| Health Authority: | Brazil: Ethics Committee |
Keywords provided by Hospital Nossa Senhora da Conceicao:
|
Weaning Chronic Obstructive Pulmonary Disease Spontaneous Breathing Trial |
Additional relevant MeSH terms:
|
Respiratory Aspiration Lung Diseases Respiration Disorders Pulmonary Disease, Chronic Obstructive |
Lung Diseases, Obstructive Respiratory Tract Diseases Signs and Symptoms, Respiratory Signs and Symptoms |
ClinicalTrials.gov processed this record on May 22, 2013