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Completed

NCT Number: NCT04418700

Effects of the Breath Stacking Technique After Upper Abdominal Surgery

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.

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Key information

Conditions

Abdominal Surgery

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Federal University of Santa Maria

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

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Breath Stacking

Device

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.

Primary outcomes

  1. 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.

  2. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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).

  8. 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.

  9. 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.

  10. 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.

  11. 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.

  12. 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.

  13. 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.

  14. 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.

  15. 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.

Sponsors and collaborators

Lead sponsor

Universidade Federal de Santa Maria

Other

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Jun 5, 2020
Registry last updated
Apr 26, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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