CardiopathyNCT02600182
Bilevel Positive Airway Pressure in Cardiac Surgery
A study testing Bilevel Positive Airway Pressure in people with Cardiopathy and Surgery, run by Prof. Dr. Antônio Marcos Vargas da Silva at 1 site in Brazil.
Trial summary
The purpose of this study was to determine the effects of Bilevel Positive Airway Pressure (BiPAP) on variables clinics, cardiorespiratory and physical functional in patients undergoing cardiac surgery at the University Hospital of Santa Maria. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cardiopathy, Surgery
- What is being tested?
- Bilevel Positive Airway Pressure
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteBrazil
- Study dates
- Dec 2015to May 2019
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Hospitalized patients in preoperative for coronary artery bypass or valve replacement.
Who cannot join
- Inability to understand or sign a free and informed consent form
- Chronic obstructive pulmonary disease (COPD)
- Cerebrovascular disease
- Musculoskeletal disease
- Chronic infectious disease
- Unstable angina
Show all 11Show fewer
- Treatment with steroids, hormones or chemotherapy for cancer
- Prolonged mechanical ventilation
- Unable of maintaining airway patency
- Severe hemodynamic instability
- Abdominal distension or vomiting.
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Federal University of Santa Maria
Santa Maria, Rio Grande do Sul, 97105-900
About this study
Official title: Effects of Bilevel Positive Airway Pressure in Postoperative Cardiac Surgery: A Randomized Clinical Trial
The purpose of this study was to determine the effects of Bilevel Positive Airway Pressure (BiPAP) on variables clinics, cardiorespiratory and physical functional in patients undergoing cardiac surgery at the University Hospital of Santa Maria.
Read the detailed description
This randomized controlled trial aimed to evaluate the effects of Bilevel Positive Airway Pressure (BiPAP) in patients undergoing heart surgery of valve replacement and coronary artery bypass graft on the variables clinics, cardiorespiratory and physical functional.These individuals were randomized to compose the control group (GC) and the BiPAP group (GBiPAP). The routine physical therapy was performed in both groups and in the BiPAPG two daily sessions of 20 minutes were applied with positive expiratory pressure of 10cmH2O and inspiratory of 15cmH2O. To verify the effect of this intervention, before and after the protocol patients underwent the following evaluations: the 6-minute walk test (6MWT), the heart rate variability, the manovacuometry, and cirtometry in the axillary line, umbilical line and the xiphoid appendix.
- Conditions
- Cardiopathy, Surgery
- Being tested
- Bilevel Positive Airway Pressure
- Keywords
- Thoracic surgery, Non-invasive ventilation, Physiotherapy
- Medical subject headings
- Heart Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bilevel Positive Airway PressureDevice
Also called BiPAP
Bilevel positive airway pressure twice per day during the hospital stay.
| Study group | Role | What they receive |
|---|---|---|
| Bilevel Positive Airway Pressure (BiPAP) | Experimental | The routine physical therapy will be performed in two groups (control and BiPAP). The BiPAP group will receive two daily sessions of 20 minutes, with positive expiratory pressure of 10cmH2O and inspiratory of 15cmH2O. Receives: Device: Bilevel Positive Airway Pressure |
| Control | No intervention | Routine physical therapy will be performed. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Peripheral Oxygen Saturation by pulse oximetry
Measured: up to 36 weeks
Secondary outcomes (7)
Vital Signs
Measured: up to 36 weeks
Length of stay
Measured: up to 36 weeks
Postoperative complications
Measured: up to 36 weeks
Six-minute walk test (6MWT)
Measured: up to 36 weeks
Heart rate variability by a pulse frequency meter
Measured: up to 36 weeks
Maximum inspiratory pressure by a digital pressure transducer (manovacuometry)
Measured: up to 36 weeks
Maximum expiratory pressure by a digital pressure transducer (manovacuometry)
Measured: up to 36 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Nov 2015 (estimated)
- Study startDec 2015
- Primary completionSep 2016
- Study completionMay 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CardiopathyStudies 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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Prof. Dr. Antônio Marcos Vargas da Silva
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Prof. Dr. Antônio Marcos Vargas da Silva, Universidade Federal de Santa Maria
- Investigators
- Antônio M Vargas da Silva, PhD, Principal investigator, Universidade Federal de Santa Maria
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02600182
- Sponsor's protocol ID
- FDAAA 801
- Status last verified
- Jan 2022
- First submitted
- 2 Nov 2015
- Last updated
- 6 Jan 2022
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 6 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Bilevel Positive Airway Pressure in Postoperative Cardiac Surgery: A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT02600182
- Acronym / sponsor ID
- FDAAA 801
- Conditions
- Cardiopathy, Surgery
- Keywords
- Thoracic surgery, Non-invasive ventilation, Physiotherapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Prof. Dr. Antônio Marcos Vargas da SilvaUniversity, hospital or other
- Study start
- Dec 2015
- Primary completion
- Sep 2016 (actual)
- Study completion
- May 2019 (actual)
- First posted
- 9 Nov 2015 (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.
The purpose of this study was to determine the effects of Bilevel Positive Airway Pressure (BiPAP) on variables clinics, cardiorespiratory and physical functional in patients undergoing cardiac surgery at the University Hospital of Santa Maria.
Detailed description
This randomized controlled trial aimed to evaluate the effects of Bilevel Positive Airway Pressure (BiPAP) in patients undergoing heart surgery of valve replacement and coronary artery bypass graft on the variables clinics, cardiorespiratory and physical functional.These individuals were randomized to compose the control group (GC) and the BiPAP group (GBiPAP). The routine physical therapy was performed in both groups and in the BiPAPG two daily sessions of 20 minutes were applied with positive expiratory pressure of 10cmH2O and inspiratory of 15cmH2O. To verify the effect of this intervention, before and after the protocol patients underwent the following evaluations: the 6-minute walk test (6MWT), the heart rate variability, the manovacuometry, and cirtometry in the axillary line, umbilical line and the xiphoid appendix.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Bilevel Positive Airway Pressure (BiPAP) | Experimental | Device: Bilevel Positive Airway PressureThe routine physical therapy will be performed in two groups (control and BiPAP). The BiPAP group will receive two daily sessions of 20 minutes, with positive expiratory pressure of 10cmH2O and inspiratory of 15cmH2O. |
| Control | No intervention | –Routine physical therapy will be performed. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Hospitalized patients in preoperative for coronary artery bypass or valve replacement.
Key exclusion criteria (11 listed)
- Inability to understand or sign a free and informed consent form
- Chronic obstructive pulmonary disease (COPD)
- Cerebrovascular disease
- Musculoskeletal disease
- Chronic infectious disease
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 |
|---|---|---|
| Bilevel Positive Airway PressureAlso: BiPAPBilevel positive airway pressure twice per day during the hospital stay. | Device | Bilevel Positive Airway Pressure (BiPAP) |
Primary outcome
Peripheral Oxygen Saturation by pulse oximetry
Time frame: up to 36 weeks
7 secondary outcomes
Vital Signs
Time frame: up to 36 weeks
Length of stay
Time frame: up to 36 weeks
Postoperative complications
Time frame: up to 36 weeks
Six-minute walk test (6MWT)
Time frame: up to 36 weeks
Heart rate variability by a pulse frequency meter
Time frame: up to 36 weeks
Maximum inspiratory pressure by a digital pressure transducer (manovacuometry)
Time frame: up to 36 weeks
Maximum expiratory pressure by a digital pressure transducer (manovacuometry)
Time frame: up to 36 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 6 Jan 2022.
- Individual participant dataSharing planned: Undecided
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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.
Antônio M Vargas da Silva, PhD principal investigator
Universidade Federal de Santa Maria
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Bilevel Positive Airway Pressure in people with Cardiopathy and Surgery, run by Prof. Dr. Antônio Marcos Vargas da Silva 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 1 inclusion and 11 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 6 Jan 2022. 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?
Peripheral Oxygen Saturation by pulse oximetry (time frame: up to 36 weeks). 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 6 Jan 2022.