Effects of the Breath Stacking Technique After Upper Abdominal Surgery

Abdominal Surgery Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04418700
• Other study ID #: 11041019.0.0000.5346
• Status: Completed
• Phase: N/A
• Start date: June 1, 2020
• Est. completion date: March 31, 2021

Study information

• Verified date: April 2021
• Source: Universidade Federal de Santa Maria
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 32
• Est. completion date: March 31, 2021
• Est. primary completion date: March 31, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Abdominal Surgery

Intervention

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.

Locations

Country	Name	City	State
Brazil	Federal University of Santa Maria	Santa Maria	Rio Grande Do Sul

Sponsors (1)

Lead Sponsor	Collaborator
Universidade Federal de Santa Maria

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.
Primary	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	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.