Weaning of Mechanical VentilationPhase 4NCT01464567
Spontaneous Breathing Trials Using Pressure-Support or T-Tube in Chronic Obstructive Pulmonary Disease Patients Weaning Mechanical Ventilation
A Phase 4 study testing "T" Tube Spontaneous Breathing Trial and Pressure Support Ventilation in people with Weaning of Mechanical Ventilation and Chronic Obstructive Pulmonary Disease, run by Hospital Nossa Senhora da Conceicao at 2 sites in Brazil.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Weaning of Mechanical Ventilation, Chronic Obstructive Pulmonary Disease
- What is being tested?
- "T" Tube Spontaneous Breathing Trial and Pressure Support Ventilation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 190 participants
- Where
- 2 sitesBrazil
- Study dates
- Jan 2012to May 2016
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- COPD patients admitted to our ICU for Acute Respiratory Failure, submitted to Mechanical Ventilation for at least 48 hours
- 18 years or older
Who cannot join
- Tracheostomy
- Younger than 18 years
- Refuse to give informed consent
- Individuals who are already enrolled in another clinical trial
Trial locations and contacts
2 sites in 1 country.
Brazil2 sites
Hospital Nossa Senhora da Conceição
Porto Alegre, Rio Grande do Sul, 91350-200
Hospital Nossa Senhora da Conceição
Porto Alegre, Rio Grande do Sul
About this study
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
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.
- Being tested
- "T" Tube Spontaneous Breathing Trial, Pressure Support Ventilation
- Keywords
- Weaning, Chronic Obstructive Pulmonary Disease, Spontaneous Breathing Trial
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
"T" Tube Spontaneous Breathing TrialProcedure or surgery
"T" Tube ventilation for 30 minutes
Pressure Support VentilationProcedure or surgery
Pressure-Support Ventilation for 30 minutes
| Study group | Role | What they receive |
|---|---|---|
| "T" Tube Spontaneous Breathing Trial | Active comparator | Spontaneous Breathing Trial wuth "T" Tube for 30 minutes. Receives: Procedure: "T" Tube Spontaneous Breathing Trial |
| Pressure Support Ventilation | Experimental | Spontaneous Breathing Trial wuth Ventilation on Pressure-Support mode set at 10cmH2O for 30 minutes Receives: Procedure: Pressure Support Ventilation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Days Spent on Mechanical Ventilation
Measured: Participants will be followed for the duration of ICU stay, an expected average of 2 weeks
Secondary outcomes (2)
Mortality
Measured: Participants will be followed for the duration of hospital stay, an expected average of 4 weeks
Extubation success rate
Measured: Participants will be followed for the duration of ICU stay, an expected average of 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Nov 2011 (estimated)
- Study startJan 2012
- Primary completionMay 2016
- Study completionMay 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Weaning of Mechanical VentilationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 190 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital Nossa Senhora da Conceicao
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jose Augusto Santos Pellegrini, Hospital Nossa Senhora da Conceicao
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01464567
- Sponsor's protocol ID
- TVEDPOC-001
- Status last verified
- Nov 2016
- First submitted
- 24 Oct 2011
- Last updated
- 25 Nov 2016
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 30138422
Study at a glance
From the registry record, last updated by the sponsor on 25 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01464567
- Acronym / sponsor ID
- TVEDPOC-001
- Keywords
- Weaning, Chronic Obstructive Pulmonary Disease, Spontaneous Breathing Trial
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 190 participants (actual)
- Lead sponsor
- Hospital Nossa Senhora da ConceicaoUniversity, hospital or other
- Study start
- Jan 2012
- Primary completion
- May 2016 (actual)
- Study completion
- May 2016 (actual)
- First posted
- 3 Nov 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| "T" Tube Spontaneous Breathing Trial | Active comparator | Procedure: "T" Tube Spontaneous Breathing TrialSpontaneous Breathing Trial wuth "T" Tube for 30 minutes. |
| Pressure Support Ventilation | Experimental | Procedure: Pressure Support VentilationSpontaneous Breathing Trial wuth Ventilation on Pressure-Support mode set at 10cmH2O for 30 minutes |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- COPD patients admitted to our ICU for Acute Respiratory Failure, submitted to Mechanical Ventilation for at least 48 hours
- 18 years or older
Key exclusion criteria (4 listed)
- Tracheostomy
- Younger than 18 years
- Refuse to give informed consent
- Individuals who are already enrolled in another clinical trial
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| "T" Tube Spontaneous Breathing Trial"T" Tube ventilation for 30 minutes | Procedure or surgery | "T" Tube Spontaneous Breathing Trial |
| Pressure Support VentilationPressure-Support Ventilation for 30 minutes | Procedure or surgery | Pressure Support Ventilation |
Primary outcome
Days Spent on Mechanical Ventilation
Time frame: Participants will be followed for the duration of ICU stay, an expected average of 2 weeks
2 secondary outcomes
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Nov 2016.
- Derived from this study: PubMed 30138422Santos 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing "T" Tube Spontaneous Breathing Trial and Pressure Support Ventilation in people with Weaning of Mechanical Ventilation and Chronic Obstructive Pulmonary Disease, run by Hospital Nossa Senhora da Conceicao at 2 sites in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Nov 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the 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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01464567, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Nov 2016.