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Acute Effect of Positive Expiratory Pressure Versus Breath Stacking Technique After Cardiac Surgery

Primary Purpose

Complication, Postoperative, Cardiac Complication

Status
Completed
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Breath Stacking
Expiratory Positive Airway Pressure
Sponsored by
Universidade Federal de Santa Maria
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Complication, Postoperative focused on measuring Cardiac Surgery, Positive End Expiratory Pressure, Physical Therapy Techniques, Pulmonary Funtcion

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Federal University of Santa Maria

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Breath Stacking

Expiratory Positive Airway Pressure

Arm Description

Instrument composed of a one-way valve coupled to a face mask to promote the accumulation of successive inspiratory volumes.

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.

Outcomes

Primary Outcome Measures

Tidal volume
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.
Forced vital capacity (FVC)
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.

Secondary Outcome Measures

Forced expiratory volume in the first second (FEV1)
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.
Peak expiratory flow (PEF)
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.
Forced expiratory flow between 25 and 75% of the curve of FVC (FEF25-75)
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.
Minute volume
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).
Respiratory rate
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.
Heart rate
They will be assessed at baseline, immediately after and 10 minutes after each intervention, through multi-parameter monitor.
Peripheral Oxygen Saturation (SpO2)
They will be assessed at baseline, immediately after and 10 minutes after each intervention through the G-Tech® portable pulse oximeter.
Blood pressure
They will be assessed at baseline, immediately after and 10 minutes after each intervention. The blood pressure will be obtained through multi-parameter monitor.
Heart work measurement
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).
Thoracoabdominal mobility
Will be evaluated by thoracic and abdominal cirtometry
Painful perception in the surgical incision
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.
Degree of dyspnea
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.
Signs of respiratory discomfort (dizziness, tachypnea, sweating, use accessory musculature)
They will be assessed at baseline, immediately after and 10 minutes after each intervention, through clinical inspection.

Full Information

First Posted
July 2, 2019
Last Updated
April 7, 2020
Sponsor
Universidade Federal de Santa Maria
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1. Study Identification

Unique Protocol Identification Number
NCT04013360
Brief Title
Acute Effect of Positive Expiratory Pressure Versus Breath Stacking Technique After Cardiac Surgery
Official Title
Acute Effect of Positive Expiratory Pressure Versus Breath Stacking Technique After Cardiac Surgery: a Randomized Crossover Trial
Study Type
Interventional

2. Study Status

Record Verification Date
April 2020
Overall Recruitment Status
Completed
Study Start Date
August 1, 2019 (Actual)
Primary Completion Date
December 30, 2019 (Actual)
Study Completion Date
February 4, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universidade Federal de Santa Maria

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Complication, Postoperative, Cardiac Complication
Keywords
Cardiac Surgery, Positive End Expiratory Pressure, Physical Therapy Techniques, Pulmonary Funtcion

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
24 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Breath Stacking
Arm Type
Active Comparator
Arm Description
Instrument composed of a one-way valve coupled to a face mask to promote the accumulation of successive inspiratory volumes.
Arm Title
Expiratory Positive Airway Pressure
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Breath Stacking
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Expiratory Positive Airway Pressure
Intervention Description
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.
Primary Outcome Measure Information:
Title
Tidal volume
Description
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.
Time Frame
12 to 24 hours after removal of drains and 24 hours after primary intervention
Title
Forced vital capacity (FVC)
Description
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.
Time Frame
12 to 24 hours after removal of drains and 24 hours after primary intervention
Secondary Outcome Measure Information:
Title
Forced expiratory volume in the first second (FEV1)
Description
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.
Time Frame
12 to 24 hours after removal of drains and 24 hours after primary intervention
Title
Peak expiratory flow (PEF)
Description
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.
Time Frame
12 to 24 hours after removal of drains and 24 hours after primary intervention
Title
Forced expiratory flow between 25 and 75% of the curve of FVC (FEF25-75)
Description
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.
Time Frame
12 to 24 hours after removal of drains and 24 hours after primary intervention
Title
Minute volume
Description
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).
Time Frame
12 to 24 hours after removal of drains and 24 hours after primary intervention
Title
Respiratory rate
Description
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.
Time Frame
12 to 24 hours after removal of drains and 24 hours after primary intervention
Title
Heart rate
Description
They will be assessed at baseline, immediately after and 10 minutes after each intervention, through multi-parameter monitor.
Time Frame
12 to 24 hours after removal of drains and 24 hours after primary intervention
Title
Peripheral Oxygen Saturation (SpO2)
Description
They will be assessed at baseline, immediately after and 10 minutes after each intervention through the G-Tech® portable pulse oximeter.
Time Frame
12 to 24 hours after removal of drains and 24 hours after primary intervention
Title
Blood pressure
Description
They will be assessed at baseline, immediately after and 10 minutes after each intervention. The blood pressure will be obtained through multi-parameter monitor.
Time Frame
12 to 24 hours after removal of drains and 24 hours after primary intervention
Title
Heart work measurement
Description
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).
Time Frame
12 to 24 hours after removal of drains and 24 hours after primary intervention
Title
Thoracoabdominal mobility
Description
Will be evaluated by thoracic and abdominal cirtometry
Time Frame
12 to 24 hours after removal of drains and 24 hours after primary intervention
Title
Painful perception in the surgical incision
Description
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.
Time Frame
12 to 24 hours after removal of drains and 24 hours after primary intervention
Title
Degree of dyspnea
Description
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.
Time Frame
12 to 24 hours after removal of drains and 24 hours after primary intervention
Title
Signs of respiratory discomfort (dizziness, tachypnea, sweating, use accessory musculature)
Description
They will be assessed at baseline, immediately after and 10 minutes after each intervention, through clinical inspection.
Time Frame
12 to 24 hours after removal of drains and 24 hours after primary intervention

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
Federal University of Santa Maria
City
Santa Maria
State/Province
Rio Grande Do Sul
ZIP/Postal Code
97105-900
Country
Brazil

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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Acute Effect of Positive Expiratory Pressure Versus Breath Stacking Technique After Cardiac Surgery

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