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

April 7, 2020 updated by: Prof. Dr. Antônio Marcos Vargas da Silva, Universidade Federal de Santa Maria

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
24

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
    • Rio Grande Do Sul
      • Santa Maria, Rio Grande Do Sul, Brazil, 97105-900
        • Federal University of Santa Maria

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: Breath Stacking
Instrument composed of a one-way valve coupled to a face mask to promote the accumulation of successive inspiratory volumes.
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.
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.
Active Comparator: 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.
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.
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Tidal volume
Time Frame: 12 to 24 hours after removal of drains and 24 hours after primary intervention
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)
Time Frame: 12 to 24 hours after removal of drains and 24 hours after primary intervention
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 Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Forced expiratory volume in the first second (FEV1)
Time Frame: 12 to 24 hours after removal of drains and 24 hours after primary intervention
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
Peak expiratory flow (PEF)
Time Frame: 12 to 24 hours after removal of drains and 24 hours after primary intervention
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
Forced expiratory flow between 25 and 75% of the curve of FVC (FEF25-75)
Time Frame: 12 to 24 hours after removal of drains and 24 hours after primary intervention
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
Minute volume
Time Frame: 12 to 24 hours after removal of drains and 24 hours after primary intervention
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
Respiratory rate
Time Frame: 12 to 24 hours after removal of drains and 24 hours after primary intervention
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
Heart rate
Time Frame: 12 to 24 hours after removal of drains and 24 hours after primary intervention
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
Peripheral Oxygen Saturation (SpO2)
Time Frame: 12 to 24 hours after removal of drains and 24 hours after primary intervention
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
Blood pressure
Time Frame: 12 to 24 hours after removal of drains and 24 hours after primary intervention
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
Heart work measurement
Time Frame: 12 to 24 hours after removal of drains and 24 hours after primary intervention
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
Thoracoabdominal mobility
Time Frame: 12 to 24 hours after removal of drains and 24 hours after primary intervention
Will be evaluated by thoracic and abdominal cirtometry
12 to 24 hours after removal of drains and 24 hours after primary intervention
Painful perception in the surgical incision
Time Frame: 12 to 24 hours after removal of drains and 24 hours after primary intervention
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
Degree of dyspnea
Time Frame: 12 to 24 hours after removal of drains and 24 hours after primary intervention
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
Signs of respiratory discomfort (dizziness, tachypnea, sweating, use accessory musculature)
Time Frame: 12 to 24 hours after removal of drains and 24 hours after primary intervention
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Universidade Federal de Santa Maria

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 1, 2019

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 30, 2019

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 4, 2020

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 2, 2019

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 6, 2019

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 9, 2019

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 9, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 7, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 92331518.6.0000.5346

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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