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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: a Randomized Crossover Trial

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04013360
Enrollment
24
Registered
2019-07-09
Start date
2019-08-01
Completion date
2020-02-04
Last updated
2020-04-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cardiac Complication, Complication, Postoperative

Keywords

Cardiac Surgery, Positive End Expiratory Pressure, Physical Therapy Techniques, Pulmonary Funtcion

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.

Interventions

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.

Sponsors

Universidade Federal de Santa Maria
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Tidal volume12 to 24 hours after removal of drains and 24 hours after primary interventionIt 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)12 to 24 hours after removal of drains and 24 hours after primary interventionIt 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

MeasureTime frameDescription
Forced expiratory flow between 25 and 75% of the curve of FVC (FEF25-75)12 to 24 hours after removal of drains and 24 hours after primary interventionIt 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 volume12 to 24 hours after removal of drains and 24 hours after primary interventionIt 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 rate12 to 24 hours after removal of drains and 24 hours after primary interventionThey 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 rate12 to 24 hours after removal of drains and 24 hours after primary interventionThey will be assessed at baseline, immediately after and 10 minutes after each intervention, through multi-parameter monitor.
Peripheral Oxygen Saturation (SpO2)12 to 24 hours after removal of drains and 24 hours after primary interventionThey will be assessed at baseline, immediately after and 10 minutes after each intervention through the G-Tech® portable pulse oximeter.
Forced expiratory volume in the first second (FEV1)12 to 24 hours after removal of drains and 24 hours after primary interventionIt 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.
Heart work measurement12 to 24 hours after removal of drains and 24 hours after primary interventionThey 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 mobility12 to 24 hours after removal of drains and 24 hours after primary interventionWill be evaluated by thoracic and abdominal cirtometry
Painful perception in the surgical incision12 to 24 hours after removal of drains and 24 hours after primary interventionWill 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 dyspnea12 to 24 hours after removal of drains and 24 hours after primary interventionWill 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)12 to 24 hours after removal of drains and 24 hours after primary interventionThey will be assessed at baseline, immediately after and 10 minutes after each intervention, through clinical inspection.
Blood pressure12 to 24 hours after removal of drains and 24 hours after primary interventionThey will be assessed at baseline, immediately after and 10 minutes after each intervention. The blood pressure will be obtained through multi-parameter monitor.
Peak expiratory flow (PEF)12 to 24 hours after removal of drains and 24 hours after primary interventionIt 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.

Countries

Brazil

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026