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

Complication, Postoperative Clinical Trial

Official title:

Acute Effect of Positive Expiratory Pressure Versus Breath Stacking Technique After Cardiac Surgery: a Randomized Crossover Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04013360
• Other study ID #: 92331518.6.0000.5346
• Status: Completed
• Phase: N/A
• Start date: August 1, 2019
• Est. completion date: February 4, 2020

Study information

• Verified date: April 2020
• Source: Universidade Federal de Santa Maria
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: February 4, 2020
• Est. primary completion date: December 30, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Cardiac Complication
• Complication, Postoperative
• Postoperative Complications

Intervention

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.
• 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.

Locations

Country	Name	City	State
Brazil	Federal University of Santa Maria	Santa Maria	Rio Grande Do Sul

Sponsors (1)

Lead Sponsor	Collaborator
Universidade Federal de Santa Maria

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	12 to 24 hours after removal of drains and 24 hours after primary intervention
Primary	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.	12 to 24 hours after removal of drains and 24 hours after primary intervention
Secondary	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.	12 to 24 hours after removal of drains and 24 hours after primary intervention
Secondary	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.	12 to 24 hours after removal of drains and 24 hours after primary intervention
Secondary	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.	12 to 24 hours after removal of drains and 24 hours after primary intervention
Secondary	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).	12 to 24 hours after removal of drains and 24 hours after primary intervention
Secondary	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.	12 to 24 hours after removal of drains and 24 hours after primary intervention
Secondary	Heart rate	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
Secondary	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.	12 to 24 hours after removal of drains and 24 hours after primary intervention
Secondary	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.	12 to 24 hours after removal of drains and 24 hours after primary intervention
Secondary	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).	12 to 24 hours after removal of drains and 24 hours after primary intervention
Secondary	Thoracoabdominal mobility	Will be evaluated by thoracic and abdominal cirtometry	12 to 24 hours after removal of drains and 24 hours after primary intervention
Secondary	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.	12 to 24 hours after removal of drains and 24 hours after primary intervention
Secondary	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.	12 to 24 hours after removal of drains and 24 hours after primary intervention
Secondary	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.	12 to 24 hours after removal of drains and 24 hours after primary intervention