Effects of the Breath Stacking Technique After Upper Abdominal Surgery

Study Overview
=================
Brief Summary
-----------------
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.

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.

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

Conditions
-----------------
Abdominal Surgery

Intervention / Treatment
-----------------
* Device: Breath Stacking


Participation Criteria
=================
Eligibility Criteria
-----------------
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.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Breath Stacking technique<br>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<br>* 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.<br>|
| No Intervention: Routine physical therapy<br>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. | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
surgery, abdomen, pulmonary ventilation, physical therapy techniques