Respiratory ComplicationNCT04631198
Effects of Conventional Physiotherapy and Thoracoabdominal Rebalancing in Post-operative of Myocardial Revascularization
A study testing Thoracoabdominal rebalancing in people with Respiratory Complication, run by Instituto de Cardiologia do Rio Grande do Sul at 1 site in Brazil.
Trial summary
When it comes to cardiovascular diseases, surgical or clinical treatment can be cited, and cardiac surgery is considered a complex and large treatment where it involves important organic repercussions that alter the physiological and hemodynamic mechanisms of patients, which can lead to a critical state… Read more about this study
- Who is it for?
- Ages 35 years and older
- Conditions the study is for
- Respiratory Complication
- What is being tested?
- Thoracoabdominal rebalancing
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 68 participants
- Where
- 1 siteBrazil
- Study dates
- 20 Jul 2020to 10 Dec 2022
- 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 35 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- The study will include individuals over 35 years of age who have undergone myocardial revascularization surgery surgery with prescribed physiotherapeutic treatment.
Who cannot join
- Patients who are intubated and / or remained on mechanical ventilation for more than 48 hours or who needed non-invasive mechanical ventilation before or during the collection period will be excluded.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of the Effects of Conventional Physiotherapy Versus Thoracoabdominal Rebalancing in Reducing Respiratory Complications in Post-operative Patients of Myocardial Revascularization Surgery
When it comes to cardiovascular diseases, surgical or clinical treatment can be cited, and cardiac surgery is considered a complex and large treatment where it involves important organic repercussions that alter the physiological and hemodynamic mechanisms of patients, which can lead to a critical state postoperatively, leading to possible complications that require intensive care at that time. Respiratory complications usually occur frequently in the postoperative period of these surgeries, causing a functional lung capacity to decrease by up to 20%, which may result in atelectasis, pneumonia, pleural effusion, among others. For this reason, physiotherapy usually plays an important role in the treatment of these patients, as it helps to reduce or treat these complications, in addition to promoting motor rehabilitation of patients before myocardial revascularization surgery. For this reason, this study aims to compare the effect of conventional physiotherapy techniques with the management of thoracoabdominal rebalancing in postoperative patients of coronary artery bypass graft. This is a randomized pilot trial in which patients who underwent coronary artery bypass surgery at the Institute of Cardiology of Rio Grande do Sul participate in the study. Patients selected for the control group (conventional physiotherapy) will be exposed to respiratory physiotherapy techniques such as vibrocompression, passive manual expiratory therapy, acceleration of expiratory flow, fractional inspiration in times, diaphragmatic breaths and aspiration when necessary, and patients selected for the intervention group, will appear on the management of thoracoabdominal rebalancing as abdominal supports and / or in the ileo-costal space, inspiratory aid, release of the scapular waist, thoracic swing, release of the pectoralis major and deltoid muscles together with aspiration, if necessary.
Read the detailed description
Compare the effect of conventional physiotherapy techniques with the management of thoracoabdominal rebalancing in postoperative myocardial revascularization surgery patients. It is a randomized pilot trial in which patients who have undergone myocardial revascularization surgery at the Institute of Cardiology of Rio Grande do Sul will participate in the study.
The study will include individuals over 35 years of age who have myocardial revascularization surgery with prescribed physiotherapeutic treatment, and will be excluded from patients whose patients were intubated and / or remained in mechanics for more than hours or, still, who required non-invasive mechanical norms before or during the collection period.
The work will be submitted to the Research Ethics Committee at the Cardiology Institute of Porto Alegre (CEP-ICFUC). All study participants will receive clear explanations regarding the research, and those who accept to participate in the study voluntarily, will sign the informed consent form, in two copies, one being made available to the participant and the other to researchers. Participants will not be paid, nor will they receive any assistance during or after the end of the survey (466/12).
The benefits of this research will be given in better conducts that prevent or reduce complications and / or respiratory discomfort as well as accelerate the patient's recovery, aiming at hospital discharge more quickly.
Patients selected for the control group (conventional physiotherapy) will be exposed to respiratory physiotherapy techniques such as vibrocompression, passive manual expiratory therapy, acceleration of expiratory flow, fractional inspiration in times, diaphragmatic breaths and aspiration when necessary, and patients selected for the group intervention, will be submitted to the handling of the thoracoabdominal rebalancing as abdominal supports and / or in the ileo-costal space, inspiratory aid, scapular waist release, thoracic swing, release of the pectoralis major and deltoid muscles together with aspiration if any need.
The research presents minimal risk for the participants, which are related to the measurement of variables and / or application of conventional physiotherapy techniques such as vibrocompression, acceleration of expiratory flow, passive manual expiratory therapy that may suggest some discomfort or pain when touching the chest in a sensation of pressure and vibration.
It is expected that patients submitted to the handling of thoracoabdominal rebalancing have lower scores on the pulmonary complications scales, Downes and Raphaelly respiratory discomfort scale and, consequently, show improvement in the other variables.
- Conditions
- Respiratory Complication
- Being tested
- Thoracoabdominal rebalancing
- Keywords
- Myocardial revascularization surgery, Physical therapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Thoracoabdominal rebalancingOther
the patients selected for the intervention group will be submitted to the handling of thoracoabdominal rebalancing as abdominal supports and / or in the ileo-costal space, inspiratory help, scapular waist release, thoracic swing, pectoralis major muscle release and deltoid together with aspiration if necessary.
| Study group | Role | What they receive |
|---|---|---|
| No Intervention: GROUP CONTROL | No intervention | Patients selected for the control group (conventional physiotherapy) will be exposed to respiratory physiotherapy techniques such as vibrocompression, manual passive expiratory therapy, expiratory flow acceleration, fractional inspiration in times, diaphragmatic breaths and aspiration when required |
| Active Comparator: INTERVENTION GROUP | Experimental | The patients selected for the intervention group will be submitted to the handling of thoracoabdominal rebalancing as abdominal supports and / or in the ileo-costal space, inspiratory help, scapular waist release, thoracic swing, pectoralis major muscle release and deltoid together with aspiration if necessary. Receives: Other: Thoracoabdominal rebalancing |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Downes and Raphaelly respiratory distress scale
Points 0-10, where 0 is better and 10 is worse
Measured: Immediately before and after 20 minutes
Secondary outcomes (5)
respiratory rate
irpm
Measured: Immediately before and after 20 minutes
peripheral saturation
SpO2
Measured: Immediately before and after 20 minutes
mean blood pressure
mmHg
Measured: Immediately before and after 20 minutes
Pulmonary auscultation assessment
Wheezing or snoring orstridor
Measured: Immediately before and after 20 minutes
heart rate
bpm
Measured: Immediately before and after 20 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Nov 2020
- Study start20 Jul 2020
- Primary completion10 Feb 2022
- Study completion10 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Respiratory ComplicationStudies 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
- Sequential
- Model description
- This is a pilot randomized clinical trial. The randomization technique for proposed proposals will be performed using a computer program (www.random.org) containing the coded distribution. The allocation confidentiality will be guaranteed by a randomization list that will be in a remote place, which will prevent the researcher from identifying which intervention will be specified by each patient. The generation of the sequence of numbers will be performed by a researcher "blind" to the study, after selection of the patients by the inclusion criteria. The sequence of numbers one used for randomization will be kept confidential until the exact moment of the beginning of the study. The randomization of the subjects in the proposed groups will be done in two blocks, in which the program will randomly distribute each new participant to one of the blocks: conventional physical therapy group and thoracoabdominal rebalancing group.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 68 participants (actual)
Sponsor and investigators
- Lead sponsor
- Instituto de Cardiologia do Rio Grande do Sul
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, KaroliniReis, Instituto de Cardiologia do Rio Grande do Sul
- Investigators
- Bruna Eibel, PhD, Study director, Instituto de Cardiologia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04631198
- Sponsor's protocol ID
- 5818/20
- Status last verified
- Apr 2023
- First submitted
- 19 Oct 2020
- Last updated
- 18 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Hulzebos EH, Van Meeteren NL, De Bie RA, Dagnelie PC, Helders PJ. Prediction of postoperative pulmonary complications on the basis of preoperative risk factors in patients who had undergone coronary artery bypass graft surgery. Phys Ther. 2003 Jan;83(1):8-16.
PubMed 12495408Cordeiro AM, Souza DC, Quinzani RH, Troster EJ. [Comparison between an upper airway obstruction score and airway endoscopy to detect airway injury associated with endotracheal intubation in children]. J Pediatr (Rio J). 2003 Nov-Dec;79(6):543-9. Portuguese.
PubMed 14685453Cavenaghi S, Ferreira LL, Marino LH, Lamari NM. Respiratory physiotherapy in the pre and postoperative myocardial revascularization surgery. Rev Bras Cir Cardiovasc. 2011 Jul-Sep;26(3):455-61. doi: 10.5935/1678-9741.20110022. English, Portuguese.
PubMed 22086584
Study at a glance
From the registry record, last updated by the sponsor on 18 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Effects of Conventional Physiotherapy Versus Thoracoabdominal Rebalancing in Reducing Respiratory Complications in Post-operative Patients of Myocardial Revascularization Surgery
- ClinicalTrials.gov ID
- NCT04631198
- Acronym / sponsor ID
- 5818/20
- Conditions
- Respiratory Complication
- Keywords
- Myocardial revascularization surgery, Physical therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 68 participants (actual)
- Lead sponsor
- Instituto de Cardiologia do Rio Grande do SulUniversity, hospital or other
- Study start
- 20 Jul 2020 (actual)
- Primary completion
- 10 Feb 2022 (actual)
- Study completion
- 10 Dec 2022 (actual)
- First posted
- 17 Nov 2020 (actual)
- 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.
When it comes to cardiovascular diseases, surgical or clinical treatment can be cited, and cardiac surgery is considered a complex and large treatment where it involves important organic repercussions that alter the physiological and hemodynamic mechanisms of patients, which can lead to a critical state postoperatively, leading to possible complications that require intensive care at that time. Respiratory complications usually occur frequently in the postoperative period of these surgeries, causing a functional lung capacity to decrease by up to 20%, which may result in atelectasis, pneumonia, pleural effusion, among others. For this reason, physiotherapy usually plays an important role in the treatment of these patients, as it helps to reduce or treat these complications, in addition to promoting motor rehabilitation of patients before myocardial revascularization surgery. For this reason, this study aims to compare the effect of conventional physiotherapy techniques with the management of thoracoabdominal rebalancing in postoperative patients of coronary artery bypass graft. This is a randomized pilot trial in which patients who underwent coronary artery bypass surgery at the Institute of Cardiology of Rio Grande do Sul participate in the study. Patients selected for the control group (conventional physiotherapy) will be exposed to respiratory physiotherapy techniques such as vibrocompression, passive manual expiratory therapy, acceleration of expiratory flow, fractional inspiration in times, diaphragmatic breaths and aspiration when necessary, and patients selected for the intervention group, will appear on the management of thoracoabdominal rebalancing as abdominal supports and / or in the ileo-costal space, inspiratory aid, release of the scapular waist, thoracic swing, release of the pectoralis major and deltoid muscles together with aspiration, if necessary.
Detailed description
Compare the effect of conventional physiotherapy techniques with the management of thoracoabdominal rebalancing in postoperative myocardial revascularization surgery patients. It is a randomized pilot trial in which patients who have undergone myocardial revascularization surgery at the Institute of Cardiology of Rio Grande do Sul will participate in the study.
The study will include individuals over 35 years of age who have myocardial revascularization surgery with prescribed physiotherapeutic treatment, and will be excluded from patients whose patients were intubated and / or remained in mechanics for more than hours or, still, who required non-invasive mechanical norms before or during the collection period.
The work will be submitted to the Research Ethics Committee at the Cardiology Institute of Porto Alegre (CEP-ICFUC). All study participants will receive clear explanations regarding the research, and those who accept to participate in the study voluntarily, will sign the informed consent form, in two copies, one being made available to the participant and the other to researchers. Participants will not be paid, nor will they receive any assistance during or after the end of the survey (466/12).
The benefits of this research will be given in better conducts that prevent or reduce complications and / or respiratory discomfort as well as accelerate the patient's recovery, aiming at hospital discharge more quickly.
Patients selected for the control group (conventional physiotherapy) will be exposed to respiratory physiotherapy techniques such as vibrocompression, passive manual expiratory therapy, acceleration of expiratory flow, fractional inspiration in times, diaphragmatic breaths and aspiration when necessary, and patients selected for the group intervention, will be submitted to the handling of the thoracoabdominal rebalancing as abdominal supports and / or in the ileo-costal space, inspiratory aid, scapular waist release, thoracic swing, release of the pectoralis major and deltoid muscles together with aspiration if any need.
The research presents minimal risk for the participants, which are related to the measurement of variables and / or application of conventional physiotherapy techniques such as vibrocompression, acceleration of expiratory flow, passive manual expiratory therapy that may suggest some discomfort or pain when touching the chest in a sensation of pressure and vibration.
It is expected that patients submitted to the handling of thoracoabdominal rebalancing have lower scores on the pulmonary complications scales, Downes and Raphaelly respiratory discomfort scale and, consequently, show improvement in the other variables.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- This is a pilot randomized clinical trial. The randomization technique for proposed proposals will be performed using a computer program (www.random.org) containing the coded distribution. The allocation confidentiality will be guaranteed by a randomization list that will be in a remote place, which will prevent the researcher from identifying which intervention will be specified by each patient. The generation of the sequence of numbers will be performed by a researcher "blind" to the study, after selection of the patients by the inclusion criteria. The sequence of numbers one used for randomization will be kept confidential until the exact moment of the beginning of the study. The randomization of the subjects in the proposed groups will be done in two blocks, in which the program will randomly distribute each new participant to one of the blocks: conventional physical therapy group and thoracoabdominal rebalancing group.
| Arm | Type | Receives |
|---|---|---|
| No Intervention: GROUP CONTROL | No intervention | –Patients selected for the control group (conventional physiotherapy) will be exposed to respiratory physiotherapy techniques such as vibrocompression, manual passive expiratory therapy, expiratory flow acceleration, fractional inspiration in times, diaphragmatic breaths and aspiration when required |
| Active Comparator: INTERVENTION GROUP | Experimental | Other: Thoracoabdominal rebalancingThe patients selected for the intervention group will be submitted to the handling of thoracoabdominal rebalancing as abdominal supports and / or in the ileo-costal space, inspiratory help, scapular waist release, thoracic swing, pectoralis major muscle release and deltoid together with aspiration if necessary. |
Who may qualify
- Ages
- 35 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- The study will include individuals over 35 years of age who have undergone myocardial revascularization surgery surgery with prescribed physiotherapeutic treatment.
Key exclusion criteria (1 listed)
- Patients who are intubated and / or remained on mechanical ventilation for more than 48 hours or who needed non-invasive mechanical ventilation before or during the collection period will be excluded.
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 |
|---|---|---|
| Thoracoabdominal rebalancingthe patients selected for the intervention group will be submitted to the handling of thoracoabdominal rebalancing as abdominal supports and / or in the ileo-costal space, inspiratory help, scapular waist release, thoracic swing, pectoralis major muscle release and deltoid together with aspiration if necessary. | Other | Active Comparator: INTERVENTION GROUP |
Primary outcome
Change in Downes and Raphaelly respiratory distress scale
Time frame: Immediately before and after 20 minutes
Points 0-10, where 0 is better and 10 is worse
5 secondary outcomes
respiratory rate
Time frame: Immediately before and after 20 minutes
peripheral saturation
Time frame: Immediately before and after 20 minutes
mean blood pressure
Time frame: Immediately before and after 20 minutes
Pulmonary auscultation assessment
Time frame: Immediately before and after 20 minutes
heart rate
Time frame: Immediately before and after 20 minutes
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 18 Apr 2023.
- Background: PubMed 12495408Hulzebos EH, Van Meeteren NL, De Bie RA, Dagnelie PC, Helders PJ. Prediction of postoperative pulmonary complications on the basis of preoperative risk factors in patients who had undergone coronary artery bypass graft surgery. Phys Ther. 2003 Jan;83(1):8-16.
- Background: PubMed 14685453Cordeiro AM, Souza DC, Quinzani RH, Troster EJ. [Comparison between an upper airway obstruction score and airway endoscopy to detect airway injury associated with endotracheal intubation in children]. J Pediatr (Rio J). 2003 Nov-Dec;79(6):543-9. Portuguese.
- Background: PubMed 22086584Cavenaghi S, Ferreira LL, Marino LH, Lamari NM. Respiratory physiotherapy in the pre and postoperative myocardial revascularization surgery. Rev Bras Cir Cardiovasc. 2011 Jul-Sep;26(3):455-61. doi: 10.5935/1678-9741.20110022. English, Portuguese.
- Individual participant dataSharing planned: No
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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.
Bruna Eibel, PhD study director
Instituto de Cardiologia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Thoracoabdominal rebalancing in people with Respiratory Complication, run by Instituto de Cardiologia do Rio Grande do Sul 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 1 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 18 Apr 2023. 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?
Change in Downes and Raphaelly respiratory distress scale (time frame: Immediately before and after 20 minutes). 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 NCT04631198, which also lists 3 linked publications.
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 18 Apr 2023.