PneumoniaNCT01416519
Physiotherapy Technique Decreases Respiratory Complications After Cardiac Operation
A study testing Continuous Positive Airway Pressure (CPAP) facial mask and Assisted deep inspiration technique in people with Pneumonia and Pleural Effusion, run by Santa Casa de Votuporanga at 1 site in Brazil.
Trial summary
The objective of this study is to assess whether there is a difference between a care protocol with the use of incentive spirometry (Voldyne ®) and another with the application of NIV (non invasive ventilation with single-level pressure) as a form of therapy. Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Pneumonia, Pleural Effusion, Atelectasis
- What is being tested?
- Continuous Positive Airway Pressure (CPAP) facial mask and Assisted deep inspiration technique
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteBrazil
- Study dates
- Sep 2011to Jan 2014
- 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 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients with indication for elective coronary artery bypass surgery who agreed to participate and signed the informed consent.
Who cannot join
- patients with hemodynamic instability during the physiotherapy care
- those who fail to complete all visits to the proposed protocol (whatever the reason)
- extubation after 12 hours of ICU admission
- major intraoperative hemorrhage
- major bleeding in ICU requiring return to the operating room
- cardiopulmonary arrest
- contraindication to positive pressure (undrained pneumothorax, bronchopleural fistula, hemoptysis, vomiting) or intolerance to the method
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Incentive Spirometry Decreases Respiratory Complications After Myocardial Revascularization
The objective of this study is to assess whether there is a difference between a care protocol with the use of incentive spirometry (Voldyne ®) and another with the application of NIV (non invasive ventilation with single-level pressure) as a form of therapy. The main focus of the study is to determine the incidence of pulmonary complications in each technique.
Read the detailed description
Coronary artery bypass graft (CABG) can prolong and improve the quality of life of patients with ischemic coronary syndrome but with the advancement of medical intervention to eligible patients for this procedure are those with more comorbidities where conservation and palliative therapies have been tried without success.
Patients undergoing CABG often develop pulmonary complications such as atelectasis, restrictive ventilatory defect, decreased lung compliance, increased shunt and changes in gas exchange leading to probable hypoxemia. In an attempt to reduce the harmful effects and pulmonary complications arising from surgical procedures is instituted extensive physiotherapy program that tracks and monitors such patients from the preoperative to the postoperative immediate transfer to the ward and hospital discharge.
The objective of this study is to assess whether there is a difference between a care protocol with the use of incentive spirometry (Voldyne ®) and another with the application of NIV (non invasive ventilation with single-level pressure) as a form of therapy. The main focus of the study is to determine the incidence of pulmonary complications in each technique.
- Conditions
- Pneumonia, Pleural Effusion, Atelectasis
- Being tested
- Continuous Positive Airway Pressure (CPAP) facial mask, Assisted deep inspiration technique
- Keywords
- Continuous Positive Airway Pressure, Cough, Oxygen Inhalation Therapy
- Medical subject headings
- Pneumonia, Pleural Effusion, Pulmonary Atelectasis, Cough
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Continuous Positive Airway Pressure (CPAP) facial maskProcedure or surgery
Also called CPAP
After extubation, starting non-invasive ventilation with face mask (1 hour) followed by assisted cough maneuver. Total of 18 calls in 72 hours distributed as long the patient was extubated.
Assisted deep inspiration techniqueProcedure or surgery
Also called Voldyne
After extubation, starting early supplemental oxygen with Venturi (FiO2 50%) with gradual weaning, applying assisted deep inspiration technique with Voldyne(R) with four sets of 10 repetitions and assisted cough maneuver. Total of 18 calls in 72 hours distributed as long the patient was extubated.
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Experimental | After extubation, starting non-invasive ventilation with face mask (1 hour) followed by assisted cough maneuver. Total of 18 calls in 72 hours distributed as long the patient was extubated. Receives: Procedure: Continuous Positive Airway Pressure (CPAP) facial mask |
| Group 2 | Experimental | After extubation, starting early supplemental oxygen with Venturi (FiO2 50%) with gradual weaning, applying assisted deep inspiration technique with Voldyne(R) with four sets of 10 repetitions and assisted cough maneuver. Total of 18 calls in 72 hours distributed as long the patient was extubated. Receives: Procedure: Assisted deep inspiration technique |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pulmonary complications
Occurrence of pulmonary complications such as pneumonia, atelectasis or pleural effusion diagnosed with chest X-rays by ICU doctor.
Measured: 72 hours
Secondary outcomes (1)
Exams
Assessment of (Sat O2) capillary saturation, (ABG) arterial blood gases.
Measured: 72 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Aug 2011 (estimated)
- Study startSep 2011
- Primary completionJan 2014
- Study completionJan 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PneumoniaStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Santa Casa de Votuporanga
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Marcos Aurelio Barboza de Oliveira, Santa Casa de Votuporanga
- Investigators
- Marcos Aurelio Barboza de Oliveira, MD, Principal investigator, Santa Casa Votuporanga
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01416519
- Sponsor's protocol ID
- U1111-1123-6476
- Other IDs
- 0035/2010
- Status last verified
- Nov 2014
- First submitted
- 12 Aug 2011
- Last updated
- 19 Nov 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 19 Nov 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Incentive Spirometry Decreases Respiratory Complications After Myocardial Revascularization
- ClinicalTrials.gov ID
- NCT01416519
- Acronym / sponsor ID
- U1111-1123-6476
- Conditions
- Pneumonia, Pleural Effusion, Atelectasis
- Keywords
- Continuous Positive Airway Pressure, Cough, Oxygen Inhalation Therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Santa Casa de VotuporangaUniversity, hospital or other
- Study start
- Sep 2011
- Primary completion
- Jan 2014 (actual)
- Study completion
- Jan 2014 (actual)
- First posted
- 15 Aug 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.
The objective of this study is to assess whether there is a difference between a care protocol with the use of incentive spirometry (Voldyne ®) and another with the application of NIV (non invasive ventilation with single-level pressure) as a form of therapy. The main focus of the study is to determine the incidence of pulmonary complications in each technique.
Detailed description
Coronary artery bypass graft (CABG) can prolong and improve the quality of life of patients with ischemic coronary syndrome but with the advancement of medical intervention to eligible patients for this procedure are those with more comorbidities where conservation and palliative therapies have been tried without success.
Patients undergoing CABG often develop pulmonary complications such as atelectasis, restrictive ventilatory defect, decreased lung compliance, increased shunt and changes in gas exchange leading to probable hypoxemia. In an attempt to reduce the harmful effects and pulmonary complications arising from surgical procedures is instituted extensive physiotherapy program that tracks and monitors such patients from the preoperative to the postoperative immediate transfer to the ward and hospital discharge.
The objective of this study is to assess whether there is a difference between a care protocol with the use of incentive spirometry (Voldyne ®) and another with the application of NIV (non invasive ventilation with single-level pressure) as a form of therapy. The main focus of the study is to determine the incidence of pulmonary complications in each technique.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1 | Experimental | Procedure: Continuous Positive Airway Pressure (CPAP) facial maskAfter extubation, starting non-invasive ventilation with face mask (1 hour) followed by assisted cough maneuver. Total of 18 calls in 72 hours distributed as long the patient was extubated. |
| Group 2 | Experimental | Procedure: Assisted deep inspiration techniqueAfter extubation, starting early supplemental oxygen with Venturi (FiO2 50%) with gradual weaning, applying assisted deep inspiration technique with Voldyne(R) with four sets of 10 repetitions and assisted cough maneuver. Total of 18 calls in 72 hours distributed as long the patient was extubated. |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Patients with indication for elective coronary artery bypass surgery who agreed to participate and signed the informed consent.
Key exclusion criteria (7 listed)
- patients with hemodynamic instability during the physiotherapy care
- those who fail to complete all visits to the proposed protocol (whatever the reason)
- extubation after 12 hours of ICU admission
- major intraoperative hemorrhage
- major bleeding in ICU requiring return to the operating room
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 |
|---|---|---|
| Continuous Positive Airway Pressure (CPAP) facial maskAlso: CPAPAfter extubation, starting non-invasive ventilation with face mask (1 hour) followed by assisted cough maneuver. Total of 18 calls in 72 hours distributed as long the patient was extubated. | Procedure or surgery | Group 1 |
| Assisted deep inspiration techniqueAlso: VoldyneAfter extubation, starting early supplemental oxygen with Venturi (FiO2 50%) with gradual weaning, applying assisted deep inspiration technique with Voldyne(R) with four sets of 10 repetitions and assisted cough maneuver. Total of 18 calls in 72 hours distributed as long the patient was extubated. | Procedure or surgery | Group 2 |
Primary outcome
Pulmonary complications
Time frame: 72 hours
Occurrence of pulmonary complications such as pneumonia, atelectasis or pleural effusion diagnosed with chest X-rays by ICU doctor.
1 secondary outcome
Exams
Time frame: 72 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 19 Nov 2014.
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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.
Marcos Aurelio Barboza de Oliveira, MD principal investigator
Santa Casa Votuporanga
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Continuous Positive Airway Pressure (CPAP) facial mask and Assisted deep inspiration technique in people with Pneumonia and Pleural Effusion, run by Santa Casa de Votuporanga 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 7 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 19 Nov 2014. 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?
Pulmonary complications (time frame: 72 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 19 Nov 2014.