Effects of the Breath Stacking Technique After Upper Abdominal Surgery

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: Completed
• Conditions: Abdominal Surgery
• Intervention / Treatment: Device: Breath Stacking

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: Interventional
• Enrollment (Actual): 32
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 63 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

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

Outcome Measure	Measure Description	Time Frame
Change from second postoperative day forced vital capacity (FVC) at 7th postoperative day or hospital discharge.	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.	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

Outcome Measure	Measure Description	Time Frame
Heart rate	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	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	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)	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	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	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	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)	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)	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)	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)	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	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	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)	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)	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

• Sponsor: Universidade Federal de Santa Maria

Publications and helpful links

General Publications

• Fernandes DDL, Righi NC, Rubin Neto LJ, Belle JM, Pippi CM, Ribas CZDM, Nichele LFI, Signori LU, Silva AMVD. Effects of the breath stacking technique after upper abdominal surgery: a randomized clinical trial. J Bras Pneumol. 2022 Mar 14;48(1):e20210280. doi: 10.36416/1806-3756/e20210280. eCollection 2022.

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2020
• Primary Completion (Actual): March 31, 2021
• Study Completion (Actual): March 31, 2021

Study Registration Dates

• First Submitted: May 21, 2020
• First Submitted That Met QC Criteria: June 2, 2020
• First Posted (Actual): June 5, 2020

Study Record Updates

• Last Update Posted (Actual): April 26, 2021
• Last Update Submitted That Met QC Criteria: April 23, 2021
• Last Verified: April 1, 2021

More Information

Terms related to this study

• Keywords: surgery; abdomen; pulmonary ventilation; physical therapy techniques
• Other Study ID 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