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出境医 / 临床实验 / Acute Effect of Positive Expiratory Pressure Versus Breath Stacking Technique After Cardiac Surgery

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

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.

Condition or disease Intervention/treatment Phase
Complication, Postoperative Cardiac Complication Other: Breath Stacking Other: Expiratory Positive Airway Pressure Not Applicable

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 Design
Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 24 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Acute Effect of Positive Expiratory Pressure Versus Breath Stacking Technique After Cardiac Surgery: a Randomized Crossover Trial
Actual Study Start Date : August 1, 2019
Actual Primary Completion Date : December 30, 2019
Actual Study Completion Date : February 4, 2020
Arms and Interventions
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.
 Other: Breath Stacking
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.

Other: Expiratory Positive Airway Pressure
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.
 Other: Breath Stacking
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.

Other: Expiratory Positive Airway Pressure
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.
Outcome Measures
Primary Outcome Measures :
  1. 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.

  2. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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).

  5. 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.

  6. 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.

  7. 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.

  8. 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.

  9. 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).

  10. 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

  11. 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. 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.

  13. 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.


Eligibility Criteria
Layout table for eligibility information
Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Contacts and Locations

Locations
Layout table for location information
Brazil
Federal University of Santa Maria
Santa Maria, Rio Grande Do Sul, Brazil, 97105-900
Sponsors and Collaborators
Universidade Federal de Santa Maria
Tracking Information
First Submitted Date  ICMJE July 2, 2019
First Posted Date  ICMJE July 9, 2019
Last Update Posted Date April 9, 2020
Actual Study Start Date  ICMJE August 1, 2019
Actual Primary Completion Date December 30, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 7, 2020)
  • 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.
  • 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.
Original Primary Outcome Measures  ICMJE
 (submitted: July 6, 2019) 		Tidal volume [ Time Frame: 12 to 24 hours after removal of drains or 24 hours after primary intervention ]
It will be evaluated preoperatively and also before and after 10 minutes of each ntervention, in the postoperative period. This measurement will be obtained through the the division of the minute volume by the respiratory rate (TV= VM/RR)
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: April 7, 2020)
  • 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.
  • 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.
  • 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.
  • 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).
  • 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.
  • 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.
  • 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.
  • 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.
  • 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).
  • 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
  • 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.
  • 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.
  • 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.
Original Secondary Outcome Measures  ICMJE
 (submitted: July 6, 2019)
  • Lung capacities [ Time Frame: 12 to 24 hours after removal of drains or 24 hours after primary intervention ]
    Will be evaluated by spirometry, before and immediately after intervention, 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. The values of forced vital capacity (FVC), forced expiratory volume in the first second (FEV1), FEV1 / FVC (FEV1 / FVC), peak expiratory flow (PEF) and forced expiratory flow between 25 and 75% of the curve of FVC (FEF25-75).
  • Minute volume [ Time Frame: 12 to 24 hours after removal of drains or 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).
  • Maximal inspiratory and expiratory pressure [ Time Frame: Preoperative period and 48 hours after removal drains ]
    Will be evaluated by digital manuvacuometer in the preoperative period and at the end of the second intervention
  • Respiratory rate [ Time Frame: 12 to 24 hours after removal of drains or 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.
  • Heart rate [ Time Frame: 12 to 24 hours after removal of drains or 24 hours after primary intervention ]
    They will be assessed at baseline, immediately after and 10 minutes after each intervention, through multi-parameter monitor.
  • Peripheral Oxygen Saturation (SpO2) [ Time Frame: 12 to 24 hours after removal of drains or 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.
  • Blood pressure [ Time Frame: 12 to 24 hours after removal of drains or 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.
  • Heart work measurement [ Time Frame: 12 to 24 hours after removal of drains or 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).
  • Thoracoabdominal mobility [ Time Frame: 12 to 24 hours after removal of drains or 24 hours after primary intervention ]
    Will be evaluated by thoracic and abdominal cirtometry
  • Painful perception in the surgical ncision [ Time Frame: 12 to 24 hours after removal of drains or 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.
  • Degree of dyspnea [ Time Frame: 12 to 24 hours after removal of drains or 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.
  • Signs of respiratory discomfort (dizziness, tachypnea, sweating, use accessory musculature) [ Time Frame: 12 to 24 hours after removal of drains or 24 hours after primary intervention ]
    They will be assessed at baseline, immediately after and 10 minutes after each intervention, through clinical inspection.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Acute Effect of Positive Expiratory Pressure Versus Breath Stacking Technique After Cardiac Surgery
Official Title  ICMJE Acute Effect of Positive Expiratory Pressure Versus Breath Stacking Technique After Cardiac Surgery: a Randomized Crossover Trial
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Complication, Postoperative
  • Cardiac Complication
Intervention  ICMJE
  • Other: Breath Stacking
    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.
  • Other: Expiratory Positive Airway Pressure
    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.
Study Arms  ICMJE
  • Active Comparator: Breath Stacking
    Instrument composed of a one-way valve coupled to a face mask to promote the accumulation of successive inspiratory volumes.
    Interventions:
    • Other: Breath Stacking
    • Other: Expiratory Positive Airway Pressure
  • 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.
    Interventions:
    • Other: Breath Stacking
    • Other: Expiratory Positive Airway Pressure
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: July 6, 2019) 		24
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE February 4, 2020
Actual Primary Completion Date December 30, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE Child, Adult, Older Adult
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Brazil
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04013360
Other Study ID Numbers  ICMJE 92331518.6.0000.5346
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party Prof. Dr. Antônio Marcos Vargas da Silva, Universidade Federal de Santa Maria
Study Sponsor  ICMJE Universidade Federal de Santa Maria
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Universidade Federal de Santa Maria
Verification Date April 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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