- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04013360
Acute Effect of Positive Expiratory Pressure Versus Breath Stacking Technique After Cardiac Surgery
April 7, 2020 updated by: Prof. Dr. Antônio Marcos Vargas da Silva, Universidade Federal de Santa Maria
Acute Effect of Positive Expiratory Pressure Versus Breath Stacking Technique After Cardiac Surgery: a Randomized Crossover Trial
This study evaluates the efficacy and safety of a single session of positive expiratory pressure and of breath stacking technique in patients after cardiac surgery.
The same patients will receive the two interventions, with an interval of 24 hours, and the acute effect of each will be verifed.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
Physiotherapy uses techniques and equipment that reduce postoperative pulmonary complications.
The technique called breath stacking consists of an instrumental feature composed of a unidirectional valve coupled to a face mask to promote the accumulation of successive inspiratory volumes.
The technique is used to prevent atelectasis and improve gas exchange.
Another therapy is called expiratory positive airway pressure (EPAP) that uses positive end expiratory pressure (PEEP) in spontaneously breathing patients, keeping the airway open during expiration.
The EPAP system consists of a face mask, a one-way valve and the expiratory resistor, which is responsible for resistance to expiratory flow, which will determine the level of PEEP.
Study Type
Interventional
Enrollment (Actual)
24
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Rio Grande Do Sul
-
Santa Maria, Rio Grande Do Sul, Brazil, 97105-900
- Federal University of Santa Maria
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
Patients with indication for coronary artery bypass grafting and valve replacement, with surgical procedure for median sternotomy.
Exclusion Criteria:
- incapacity to understand the Informed Consent Form.
- cognitive dysfunction that prevents the performance of evaluations or interventions,
- intolerance to the use of EPAP or BS mask
- with chronic obstructive pulmonary disease (COPD)
- cerebrovascular disease
- chronic-degenerative musculoskeletal disease
- chronic infectious disease
- in treatment with steroids, hormones or cancer chemotherapy
- hemodynamic complications (arrhythmia, myocardial infarction during the operation, with blood loss ≥ 20% of the total blood volume, defined by Mannuci, et al., 2007)
- mean arterial pressure <70 mmHg and reduced cardiac output, requiring the use of intra aortic balloon or vasoactive drugs
- tracheal intubation for more than 12 hours after admission to the ICU or reintubated
- individuals unable to maintain airway permeability.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Breath Stacking
Instrument composed of a one-way valve coupled to a face mask to promote the accumulation of successive inspiratory volumes.
|
The patients will perform the maneuver through successive inspiratory efforts for 20 s.
Subsequently, the expiratory branch will be unobstructed to allow expiration.
This maneuver will be repeated 5 times in each series, with intervals of 30 seconds between them.
The technique will be performed with the trunk inclined 30º in relation to the horizontal plane, in 3 series, with interval of 2 min completing 15 min of therapy.
Patients will perform exhalation of air through a facial mask containing an extrinsic positive expiratory pressure valve with a defined load of 10 cmH2O for 5 min.
During the application of the technique the patients will have a trunk inclined 30º and will be stimulated to breathe normally, without effort or deep and fast breaths.
|
Active Comparator: Expiratory Positive Airway Pressure
Therapeutic technique consisting of a face mask, a one-way valve and an expiratory resistor, responsible for resistance to expiratory flow, which will determine the level of pressure in the airway.
|
The patients will perform the maneuver through successive inspiratory efforts for 20 s.
Subsequently, the expiratory branch will be unobstructed to allow expiration.
This maneuver will be repeated 5 times in each series, with intervals of 30 seconds between them.
The technique will be performed with the trunk inclined 30º in relation to the horizontal plane, in 3 series, with interval of 2 min completing 15 min of therapy.
Patients will perform exhalation of air through a facial mask containing an extrinsic positive expiratory pressure valve with a defined load of 10 cmH2O for 5 min.
During the application of the technique the patients will have a trunk inclined 30º and will be stimulated to breathe normally, without effort or deep and fast breaths.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Tidal volume
Time Frame: 12 to 24 hours after removal of drains and 24 hours after primary intervention
|
It will be evaluated preoperatively and also before and after 10 minutes of each intervention, in the postoperative period.
This measurement will be obtained through the the division of the minute volume by the respiratory rate.
|
12 to 24 hours after removal of drains and 24 hours after primary intervention
|
Forced vital capacity (FVC)
Time Frame: 12 to 24 hours after removal of drains and 24 hours after primary intervention
|
It will be evaluated preoperatively and also before and after 10 minutes of each intervention, in the postoperative period, as recommended by the American Thoracic Society and European Respiratory Society (2006) and based on reproducibility and acceptability criteria, three maneuvers will be performed (variability <5%) and considered the best curve for the study.
|
12 to 24 hours after removal of drains and 24 hours after primary intervention
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Forced expiratory volume in the first second (FEV1)
Time Frame: 12 to 24 hours after removal of drains and 24 hours after primary intervention
|
It will be evaluated preoperatively and also before and after 10 minutes of each intervention, in the postoperative period, as recommended by the American Thoracic Society and European Respiratory Society (2006) and based on reproducibility and acceptability criteria, three maneuvers will be performed (variability <5%) and considered the best curve for the study.
|
12 to 24 hours after removal of drains and 24 hours after primary intervention
|
Peak expiratory flow (PEF)
Time Frame: 12 to 24 hours after removal of drains and 24 hours after primary intervention
|
It will be evaluated preoperatively and also before and after 10 minutes of each intervention, in the postoperative period, as recommended by the American Thoracic Society and European Respiratory Society (2006) and based on reproducibility and acceptability criteria, three maneuvers will be performed (variability <5%) and considered the best curve for the study.
|
12 to 24 hours after removal of drains and 24 hours after primary intervention
|
Forced expiratory flow between 25 and 75% of the curve of FVC (FEF25-75)
Time Frame: 12 to 24 hours after removal of drains and 24 hours after primary intervention
|
It will be evaluated preoperatively and also before and after 10 minutes of each intervention, in the postoperative period, as recommended by the American Thoracic Society and European Respiratory Society (2006) and based on reproducibility and acceptability criteria, three maneuvers will be performed (variability <5%) and considered the best curve for the study.
|
12 to 24 hours after removal of drains and 24 hours after primary intervention
|
Minute volume
Time Frame: 12 to 24 hours after removal of drains and 24 hours after primary intervention
|
It will be evaluated preoperatively and also before and after 10 minutes of each intervention.
To obtain the Minute Volume (MV), the patient will be instructed to inhale and exhale slowly for one minute and the value of MV and respiratory rate (RR) will be recorded.
The respiratory rate was measured by the movements of the rib cage during respiratory cycles performed in one minute.
The MV will be obtained by a Wright ® ventilometer (British Oxigen Company, London, England).
|
12 to 24 hours after removal of drains and 24 hours after primary intervention
|
Respiratory rate
Time Frame: 12 to 24 hours after removal of drains and 24 hours after primary intervention
|
They will be assessed at baseline, immediately after and 10 minutes after each intervention.
The respiratory rate was measured by the movements of the rib cage during respiratory cycles performed in one minute.
|
12 to 24 hours after removal of drains and 24 hours after primary intervention
|
Heart rate
Time Frame: 12 to 24 hours after removal of drains and 24 hours after primary intervention
|
They will be assessed at baseline, immediately after and 10 minutes after each intervention, through multi-parameter monitor.
|
12 to 24 hours after removal of drains and 24 hours after primary intervention
|
Peripheral Oxygen Saturation (SpO2)
Time Frame: 12 to 24 hours after removal of drains and 24 hours after primary intervention
|
They will be assessed at baseline, immediately after and 10 minutes after each intervention through the G-Tech® portable pulse oximeter.
|
12 to 24 hours after removal of drains and 24 hours after primary intervention
|
Blood pressure
Time Frame: 12 to 24 hours after removal of drains and 24 hours after primary intervention
|
They will be assessed at baseline, immediately after and 10 minutes after each intervention.
The blood pressure will be obtained through multi-parameter monitor.
|
12 to 24 hours after removal of drains and 24 hours after primary intervention
|
Heart work measurement
Time Frame: 12 to 24 hours after removal of drains and 24 hours after primary intervention
|
They will be assessed at baseline, immediately after and 10 minutes after each intervention through the calculation of the double product (multiplication of systolic blood pressure by heart rate).
|
12 to 24 hours after removal of drains and 24 hours after primary intervention
|
Thoracoabdominal mobility
Time Frame: 12 to 24 hours after removal of drains and 24 hours after primary intervention
|
Will be evaluated by thoracic and abdominal cirtometry
|
12 to 24 hours after removal of drains and 24 hours after primary intervention
|
Painful perception in the surgical incision
Time Frame: 12 to 24 hours after removal of drains and 24 hours after primary intervention
|
Will be assessed at baseline, immediately after and 10 minutes after each intervention through a Visual Analog Scale, a one-dimensional instrument for evaluation of pain intensity, with a range of 1 to 10.
|
12 to 24 hours after removal of drains and 24 hours after primary intervention
|
Degree of dyspnea
Time Frame: 12 to 24 hours after removal of drains and 24 hours after primary intervention
|
Will be assessed at baseline, immediately after and 10 minutes after each intervention, through the Modified Borg Scale, a vertical scale quantified from 0 to 10. Zero represents no symptoms and 10 represents maximum symptoms.
|
12 to 24 hours after removal of drains and 24 hours after primary intervention
|
Signs of respiratory discomfort (dizziness, tachypnea, sweating, use accessory musculature)
Time Frame: 12 to 24 hours after removal of drains and 24 hours after primary intervention
|
They will be assessed at baseline, immediately after and 10 minutes after each intervention, through clinical inspection.
|
12 to 24 hours after removal of drains and 24 hours after primary intervention
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
August 1, 2019
Primary Completion (Actual)
December 30, 2019
Study Completion (Actual)
February 4, 2020
Study Registration Dates
First Submitted
July 2, 2019
First Submitted That Met QC Criteria
July 6, 2019
First Posted (Actual)
July 9, 2019
Study Record Updates
Last Update Posted (Actual)
April 9, 2020
Last Update Submitted That Met QC Criteria
April 7, 2020
Last Verified
April 1, 2020
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 92331518.6.0000.5346
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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