Clinical trial NCT04013360: 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
Overall status: COMPLETED
Phase: NA
Conditions: Complication, Postoperative
Cardiac Complication
Keywords: Cardiac Surgery
Positive End Expiratory Pressure
Physical Therapy Techniques
Pulmonary Funtcion
Lead sponsor: Universidade Federal de Santa Maria
Sponsor class: OTHER
First posted: 2019-07-09
Enrollment: 24
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Tidal volume
timeFrame: 12 to 24 hours after removal of drains and 24 hours after primary intervention
measure: Forced vital capacity (FVC)
timeFrame: 12 to 24 hours after removal of drains and 24 hours after primary intervention
Secondary outcomes:
measure: Forced expiratory volume in the first second (FEV1)
timeFrame: 12 to 24 hours after removal of drains and 24 hours after primary intervention
measure: Peak expiratory flow (PEF)
timeFrame: 12 to 24 hours after removal of drains and 24 hours after primary intervention
measure: Forced expiratory flow between 25 and 75% of the curve of FVC (FEF25-75)
timeFrame: 12 to 24 hours after removal of drains and 24 hours after primary intervention
measure: Minute volume
timeFrame: 12 to 24 hours after removal of drains and 24 hours after primary intervention
measure: Respiratory rate
timeFrame: 12 to 24 hours after removal of drains and 24 hours after primary intervention
measure: Heart rate
timeFrame: 12 to 24 hours after removal of drains and 24 hours after primary intervention
measure: Peripheral Oxygen Saturation (SpO2)
timeFrame: 12 to 24 hours after removal of drains and 24 hours after primary intervention
measure: Blood pressure
timeFrame: 12 to 24 hours after removal of drains and 24 hours after primary intervention
measure: Heart work measurement
timeFrame: 12 to 24 hours after removal of drains and 24 hours after primary intervention
measure: Thoracoabdominal mobility
timeFrame: 12 to 24 hours after removal of drains and 24 hours after primary intervention
measure: Painful perception in the surgical incision
timeFrame: 12 to 24 hours after removal of drains and 24 hours after primary intervention
measure: Degree of dyspnea
timeFrame: 12 to 24 hours after removal of drains and 24 hours after primary intervention
measure: Signs of respiratory discomfort (dizziness, tachypnea, sweating, use accessory musculature)
timeFrame: 12 to 24 hours after removal of drains and 24 hours after primary intervention
Other outcomes:
Locations:
city: Santa Maria
country: Brazil
facility: Federal University of Santa Maria
state: Rio Grande Do Sul
Study officials:
References: