Effects of the Breath Stacking Technique After Upper Abdominal Surgery

April 23, 2021 updated by: Prof. Dr. Antônio Marcos Vargas da Silva, Universidade Federal de Santa Maria

Effects of the Breath Stacking Technique After Upper Abdominal Surgery: Randomized Controlled Trial

This study evaluates the effects of the breath stacking technique in patients after upper abdominal surgery. Half of the patients receive routine physical therapy associated with the Breath Stacking technique, while the other half will receive only routine physical therapy.

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

This randomized controlled study aims to evaluate the effects of the Breath Stacking technique in patients undergoing upper abdominal surgery on clinical, physiological and cardiopulmonary variables. These individuals were randomized to compose the control group (CG) and the intervention group (GBS). The routine physical therapy was performed in both groups and in the GBS two daily sessions of up to 20 minutes of Breath Stacking technique were applied. To verify the effect of this intervention, before and after the protocol, patients underwent the following evaluations: algometry, cirtometry in the axillary line , umbilical line and the xiphoid process, ventilometry, spirometry and manovacuometry.

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.
32

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

14 years to 61 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients undergoing a surgical procedure that involves in an incision in the upper quadrants of the abdominal region.

Exclusion Criteria:

  • Intolerance to the use of BS mask.
  • Chronic obstructive pulmonary disease (COPD), Asthma, Chron's disease.
  • Liver trauma severe with hemodynamic repercussions.
  • Patients undergoing esophagectomy.
  • Sepsis with complications postoperative hemodynamics.
  • Need for surgical reintervention.
  • Forwarded to Intensive Care Unit or need for mechanical ventilation after discharge from the anesthetic recovery.
  • Cognitive dysfunction that makes it impossible to understand and execute evaluations and intervention.

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: Parallel 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.
Experimental: Breath Stacking technique

The intervention group will receive routine physical therapy associated with the Breath Stacking technique in 2 daily sessions of up to 20 minutes.

The technique consists of an Instrument composed of a one-way valve coupled to a face mask to promote the accumulation of successive inspiratory volumes.
Device: 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.
No Intervention: Routine physical therapy
The control group will receive only routine physical therapy. Routine physiotherapy consists of breathing exercises, using techniques bronchial hygiene and pulmonary reexpansion, and motor physiotherapy through exercise passive, active-assisted or active mobilization, stretching, training activities of daily living, positioning and removal of the bed and guidelines for post-discharge.

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
Change from second postoperative day forced vital capacity (FVC) at 7th postoperative day or hospital discharge.
Time Frame: The change in FVC will be evaluated on the 2nd postoperative day and up to 7th postoperative day.
The FVC will be evaluated 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.
The change in FVC will be evaluated on the 2nd postoperative day and up to 7th postoperative day.
Change from second postoperative day tidal volume at 7th postoperative day or hospital discharge.
Time Frame: The change in tidal volume will be evaluated on the 2nd postoperative day and up to 7th postoperative day.
Tidal volume will be obtained through the division of the minute volume by the respiratory rate.
The change in tidal volume will be evaluated on the 2nd postoperative day and up to 7th postoperative day.

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
Heart rate
Time Frame: It will be evaluated on the 2nd postoperative day and up to 7th postoperative day. This variable will also be measured before and after the first and last BS session.
It will be evaluated with portable pulse oximeter.
It will be evaluated on the 2nd postoperative day and up to 7th postoperative day. This variable will also be measured before and after the first and last BS session.
Respiratory rate
Time Frame: It will be evaluated on the 2nd postoperative day and up to 7th postoperative day. This variable will also be measured before and after the first and last BS session.
The respiratory rate will be measured by the movements of the rib cage during respiratory cycles performed in one minute.
It will be evaluated on the 2nd postoperative day and up to 7th postoperative day. This variable will also be measured before and after the first and last BS session.
Blood pressure
Time Frame: These will be evaluated on the 2nd postoperative day and up to 7th postoperative day. These will also be measured before and after the first and last BS session.
Systolic and diastolic blood pressure will be verified by a stethoscope and sphygmomanometer.
These will be evaluated on the 2nd postoperative day and up to 7th postoperative day. These will also be measured before and after the first and last BS session.
Peripheral oxygen saturation (SpO2)
Time Frame: It will be evaluated on the 2nd postoperative day and up to 7th postoperative day. This variable will also be measured before and after the first and last BS session.
It will be evaluated with portable pulse oximeter.
It will be evaluated on the 2nd postoperative day and up to 7th postoperative day. This variable will also be measured before and after the first and last BS session.
Painful perception in the surgical incision
Time Frame: It will be evaluated on the 2nd postoperative day and up to 7th postoperative day.
The digital algometer will be used, which constitutes a dynamometer that exerts pressure with a rubber tip 1 cm in diameter on the skin, at a 90º angle, determining the pain threshold.
It will be evaluated on the 2nd postoperative day and up to 7th postoperative day.
Thoracoabdominal mobility
Time Frame: It will be evaluated on the 2nd postoperative day and up to 7th postoperative day.
The measuring tape will be positioned in three anatomical points: axillary fold, xiphoid appendix and umbilical line. The measurements will be performed at rest, after maximum inspiration and after maximum expiration.
It will be evaluated on the 2nd postoperative day and up to 7th postoperative day.
Minute volume
Time Frame: It will be evaluated on the 2nd postoperative day and up to 7th postoperative day.
To obtain the minute volume (MV), the patient will be instructed to inhale and exhale slowly using the Wright ® ventilometer (British Oxygen Company, London, England).
It will be evaluated on the 2nd postoperative day and up to 7th postoperative day.
Forced expiratory volume in the first second (FEV1)
Time Frame: It will be evaluated on the 2nd postoperative day and up to 7th postoperative day.
It will be evaluated 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.
It will be evaluated on the 2nd postoperative day and up to 7th postoperative day.
FEV1 / FVC ratio (FEV1 / FVC)
Time Frame: It will be evaluated on the 2nd postoperative day and up to 7th postoperative day.
It will be evaluated 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.
It will be evaluated on the 2nd postoperative day and up to 7th postoperative day.
Peak expiratory flow (PEF)
Time Frame: It will be evaluated on the 2nd postoperative day and up to 7th postoperative day.
It will be evaluated 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.
It will be evaluated on the 2nd postoperative day and up to 7th postoperative day.
Forced expiratory flow between 25 and 75% of the curve of FVC (FEF25-75)
Time Frame: It will be evaluated on the 2nd postoperative day and up to 7th postoperative day.
It will be evaluated 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.
It will be evaluated on the 2nd postoperative day and up to 7th postoperative day.
Respiratory muscle strength
Time Frame: These will be evaluated on the 2nd postoperative day and up to 7th postoperative day.
The maximal inspiratory and expiratory pressures will be evaluated with manovacuometer.
These will be evaluated on the 2nd postoperative day and up to 7th postoperative day.
Degree of dyspnea
Time Frame: It will be evaluated before and after the application of the BS technique (therefore, only in GBS) on the 2nd postoperative day and up to 7th postoperative day.
It will be evaluated using the modified Borg Scale, a vertical scale quantified from 0 to 10. Zero represents no symptoms and 10 represents the maximum of symptoms.
It will be evaluated before and after the application of the BS technique (therefore, only in GBS) on the 2nd postoperative day and up to 7th postoperative day.
Rates of signs of respiratory discomfort (dizziness, tachypnea, sweating, use accessory musculature)
Time Frame: These will be evaluated before and after the application of the BS technique (therefore, only in GBS) on the 2nd postoperative day and up to 7th postoperative day.
Evaluated through clinical inspection.
These will be evaluated before and after the application of the BS technique (therefore, only in GBS) on the 2nd postoperative day and up to 7th postoperative day.
Rates of gastrointestinal symptoms (pain abdominal, nausea, vomiting)
Time Frame: These will be evaluated before and after the application of the BS technique (therefore, only in GBS) on the 2nd postoperative day and up to 7th postoperative day.
Evaluated through clinical inspection.
These will be evaluated before and after the application of the BS technique (therefore, only in GBS) on the 2nd postoperative day and up to 7th postoperative day.

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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.
June 1, 2020

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.
March 31, 2021

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.
March 31, 2021

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).
May 21, 2020

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.
June 2, 2020

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.
June 5, 2020

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 26, 2021

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 23, 2021

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, 2021

More Information

Terms related to this study

Keywords

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.
  • 11041019.0.0000.5346

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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