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

NCT ID: NCT04013360

Last Updated: 2020-04-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 24 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-08-01
• Study Completion Date: 2020-02-04

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.

Conditions

Complication, Postoperative; Cardiac Complication

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Breath Stacking

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

Group Type: ACTIVE_COMPARATOR

Breath Stacking

Intervention Type: OTHER

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

Intervention Type: OTHER

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.

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.

Group Type: ACTIVE_COMPARATOR

Breath Stacking

Intervention Type: OTHER

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

Intervention Type: OTHER

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: OTHER

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.

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Universidade Federal de Santa Maria

OTHER

Sponsor Role: lead

Responsible Party

Prof. Dr. Antônio Marcos Vargas da Silva

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Federal University of Santa Maria

Santa Maria, Rio Grande do Sul, Brazil

Countries

Brazil

Other Identifiers

92331518.6.0000.5346

Identifier Type: -

Identifier Source: org_study_id