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

NCT04013360 | Completed DMC

• 1 other identifier: 92331518.6.0000.5346
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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.

Conditions

Complication, Postoperative; Cardiac Complication

Keywords

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

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (13)

• Forced expiratory volume in the first second (FEV1)

  12 to 24 hours after removal of drains and 24 hours after primary intervention

• Peak expiratory flow (PEF)

  12 to 24 hours after removal of drains and 24 hours after primary intervention

• 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 intervention

• Minute volume

  12 to 24 hours after removal of drains and 24 hours after primary intervention

• Respiratory rate

  12 to 24 hours after removal of drains and 24 hours after primary intervention

Study Arms (2)

Breath Stacking

ACTIVE COMPARATOR

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

Other: Breath Stacking; Other: Expiratory Positive Airway Pressure

Expiratory Positive Airway Pressure

ACTIVE COMPARATOR

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; Other: Expiratory Positive Airway Pressure

Interventions

Breath Stacking 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.

Breath Stacking; Expiratory Positive Airway Pressure

Expiratory Positive Airway Pressure 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.

Breath Stacking; Expiratory Positive Airway Pressure

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with indication for coronary artery bypass grafting and valve replacement, with surgical procedure for median sternotomy.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Universidade Federal de Santa Maria: lead

Study Sites (1)

Federal University of Santa Maria

Santa Maria, Rio Grande do Sul, 97105-900, Brazil

Location

MeSH Terms

Conditions

Postoperative Complications

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: July 2, 2019
• First Posted: July 9, 2019
• Study Start: August 1, 2019
• Primary Completion: December 30, 2019
• Study Completion: February 4, 2020
• Last Updated: April 9, 2020

Record last verified: 2020-04

Locations

BR (1)