Heart; Dysfunction Postoperative, Cardiac SurgeryNCT01457898
Non-invasive Mechanical Ventilation After Cardiac Surgery
A study testing VPAP II® in people with Heart; Dysfunction Postoperative, Cardiac Surgery, run by Irmandade Santa Casa de Misericórdia de Porto Alegre at 1 site in Brazil.
Trial summary
Non-invasive mechanical ventilation (NIV) has been used in hypoxic post-operative cardiac patients but more studies are necessary to clarify its respiratory and hemodynamic effects. Read more about this study
- Who is it for?
- Ages 20 to 85 years
- Conditions the study is for
- Heart; Dysfunction Postoperative, Cardiac Surgery
- What is being tested?
- VPAP II®
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 1 siteBrazil
- Study dates
- Apr 2008to May 2009
- Phase
- Interventional
- 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 20 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Oxygenation index (PaO2/FiO2)between 150 and 300 one hour after extubation following cardiac surgery.
- Swan-Ganz catheter
Who cannot join
- Invasive mechanical ventilation more than 24 hours
- Serious obstructive pulmonary chronic disease (FEV1<40%)
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Santa Casa de Misericórdia de Porto Alegre
Porto Alegre, Rio Grande do Sul, 90020-090
About this study
Official title: Effects of Non-invasive Mechanical Ventilation on Hemodynamics and Gas Exchanges Parameters After Cardiac Surgery in Patients With Relative Hypoxemia
Non-invasive mechanical ventilation (NIV) has been used in hypoxic post-operative cardiac patients but more studies are necessary to clarify its respiratory and hemodynamic effects. Therefore, the investigators objective was to study its effects in the oxygenation index (PaO2/FiO2) and in hemodynamic variables in this group of patients.
Read the detailed description
- Postoperative cardiac surgery patients having a Swan-Ganz catheter and showing a PaO2/FiO2 between 150 and 300 (with FIO2 0.31), one hour after extubation, were included.
- Then, the patients were randomized into two groups: control and intervention group. Intervention group used NIV with a bi-level positive airway pressure (an inspiratory pressure to generate a tidal volume of 6ml/kg and an expiratory pressure of 7cmH2O) with a FIO2 0.4. Control group used oxygen by Venturi mask(FIO2 0.4) in order to keep a good oxygenation.
- In both groups measurements were done in basal situation, one and three hours after beginning the treatment and one hour after stop the treatment (FiO2 0.31).
- Variables studied included: PaO2/FiO2, PaO2, PaCO2, heart rate (HR), mean arterial pressure (MAP), pulmonary capillary wedge pressure (PCWP) and cardiac output (CO).
- Being tested
- VPAP II®
- Keywords
- Cardiac surgery, Non-invasive ventilation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VPAP II®Device
Also called VPAP II -STA (Resmed®)
VPAP group:inspiratory pressure to generate 6ml/kg of weight and expiratory pressure of 7cmH2O plus oxygen therapy (FIO2=40%) during three hours.
| Study group | Role | What they receive |
|---|---|---|
| VPAP II® | Experimental | VPAP II® Group Receives: Device: VPAP II® |
What is being measured
The primary outcome is the main question the study is designed to answer.
Oxygenation index (PaO2/FiO2)
Measured: 5 hours
Secondary outcomes (4)
Heart rate (HR)
Measured: 5 hours
Mean arterial pressure (MAP)
Measured: 5 hours
Pulmonary capillary wedge pressure (PCWP)
Measured: 5 hours
Cardiac output (CO)
Measured: 5 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Oct 2011 (estimated)
- Study startApr 2008
- Primary completionMay 2009
- Study completionMay 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart; Dysfunction Postoperative, Cardiac SurgeryStudies 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 N/A
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- Irmandade Santa Casa de Misericórdia de Porto Alegre
- Sponsor type
- University, hospital or other
- Collaborators
- Federal University of Rio Grande do Sul
- Responsible party
- Principal investigator, Alessandra Preisig, Irmandade Santa Casa de Misericórdia de Porto Alegre
- Investigators
- Alessandra P Werlang, MsC, Principal investigator, Federal University of Rio Grande do Sul
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01457898
- Sponsor's protocol ID
- 1751/07
- Status last verified
- Oct 2011
- First submitted
- 19 Oct 2011
- Last updated
- 25 Oct 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Oct 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Non-invasive Mechanical Ventilation on Hemodynamics and Gas Exchanges Parameters After Cardiac Surgery in Patients With Relative Hypoxemia
- ClinicalTrials.gov ID
- NCT01457898
- Acronym / sponsor ID
- 1751/07
- Keywords
- Cardiac surgery, Non-invasive ventilation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- Irmandade Santa Casa de Misericórdia de Porto AlegreUniversity, hospital or other
- Collaborators
- Federal University of Rio Grande do Sul
- Study start
- Apr 2008
- Primary completion
- May 2009 (actual)
- Study completion
- May 2009 (actual)
- First posted
- 24 Oct 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.
Non-invasive mechanical ventilation (NIV) has been used in hypoxic post-operative cardiac patients but more studies are necessary to clarify its respiratory and hemodynamic effects. Therefore, the investigators objective was to study its effects in the oxygenation index (PaO2/FiO2) and in hemodynamic variables in this group of patients.
Detailed description
- Postoperative cardiac surgery patients having a Swan-Ganz catheter and showing a PaO2/FiO2 between 150 and 300 (with FIO2 0.31), one hour after extubation, were included.
- Then, the patients were randomized into two groups: control and intervention group. Intervention group used NIV with a bi-level positive airway pressure (an inspiratory pressure to generate a tidal volume of 6ml/kg and an expiratory pressure of 7cmH2O) with a FIO2 0.4. Control group used oxygen by Venturi mask(FIO2 0.4) in order to keep a good oxygenation.
- In both groups measurements were done in basal situation, one and three hours after beginning the treatment and one hour after stop the treatment (FiO2 0.31).
- Variables studied included: PaO2/FiO2, PaO2, PaCO2, heart rate (HR), mean arterial pressure (MAP), pulmonary capillary wedge pressure (PCWP) and cardiac output (CO).
Study design
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| VPAP II® | Experimental | Device: VPAP II®VPAP II® Group |
Who may qualify
- Ages
- 20 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Oxygenation index (PaO2/FiO2)between 150 and 300 one hour after extubation following cardiac surgery.
- Swan-Ganz catheter
Key exclusion criteria (2 listed)
- Invasive mechanical ventilation more than 24 hours
- Serious obstructive pulmonary chronic disease (FEV1<40%)
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 |
|---|---|---|
| VPAP II®Also: VPAP II -STA (Resmed®)VPAP group:inspiratory pressure to generate 6ml/kg of weight and expiratory pressure of 7cmH2O plus oxygen therapy (FIO2=40%) during three hours. | Device | VPAP II® |
Primary outcome
Oxygenation index (PaO2/FiO2)
Time frame: 5 hours
4 secondary outcomes
Heart rate (HR)
Time frame: 5 hours
Mean arterial pressure (MAP)
Time frame: 5 hours
Pulmonary capillary wedge pressure (PCWP)
Time frame: 5 hours
Cardiac output (CO)
Time frame: 5 hours
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 Oct 2011.
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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.
Alessandra P Werlang, MsC principal investigator
Federal University of Rio Grande do Sul
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing VPAP II® in people with Heart; Dysfunction Postoperative, Cardiac Surgery, run by Irmandade Santa Casa de Misericórdia de Porto Alegre at 1 site 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 2 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 Oct 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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.
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?
Oxygenation index (PaO2/FiO2) (time frame: 5 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 Oct 2011.