Clinical trial NCT04418700: Effects of the Breath Stacking Technique After Upper Abdominal Surgery
Official title: Effects of the Breath Stacking Technique After Upper Abdominal Surgery: Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Abdominal Surgery
Keywords: surgery
abdomen
pulmonary ventilation
physical therapy techniques
Lead sponsor: Universidade Federal de Santa Maria
Sponsor class: OTHER
First posted: 2020-06-05
Enrollment: 32
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Change from second postoperative day forced vital capacity (FVC) at 7th postoperative day or hospital discharge.
timeFrame: The change in FVC will be evaluated on the 2nd postoperative day and up to 7th postoperative day.
measure: Change from second postoperative day tidal volume at 7th postoperative day or hospital discharge.
timeFrame: The change in tidal volume will be evaluated on the 2nd postoperative day and up to 7th postoperative day.
Secondary outcomes:
measure: Heart rate
timeFrame: 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.
measure: Respiratory rate
timeFrame: 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.
measure: Blood pressure
timeFrame: 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.
measure: Peripheral oxygen saturation (SpO2)
timeFrame: 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.
measure: Painful perception in the surgical incision
timeFrame: It will be evaluated on the 2nd postoperative day and up to 7th postoperative day.
measure: Thoracoabdominal mobility
timeFrame: It will be evaluated on the 2nd postoperative day and up to 7th postoperative day.
measure: Minute volume
timeFrame: It will be evaluated on the 2nd postoperative day and up to 7th postoperative day.
measure: Forced expiratory volume in the first second (FEV1)
timeFrame: It will be evaluated on the 2nd postoperative day and up to 7th postoperative day.
measure: FEV1 / FVC ratio (FEV1 / FVC)
timeFrame: It will be evaluated on the 2nd postoperative day and up to 7th postoperative day.
measure: Peak expiratory flow (PEF)
timeFrame: It will be evaluated on the 2nd postoperative day and up to 7th postoperative day.
measure: Forced expiratory flow between 25 and 75% of the curve of FVC (FEF25-75)
timeFrame: It will be evaluated on the 2nd postoperative day and up to 7th postoperative day.
measure: Respiratory muscle strength
timeFrame: These will be evaluated on the 2nd postoperative day and up to 7th postoperative day.
measure: Degree of dyspnea
timeFrame: 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.
measure: Rates of signs of respiratory discomfort (dizziness, tachypnea, sweating, use accessory musculature)
timeFrame: 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.
measure: Rates of gastrointestinal symptoms (pain abdominal, nausea, vomiting)
timeFrame: 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.
Other outcomes:
Locations:
city: Santa Maria
country: Brazil
facility: Federal University of Santa Maria
state: Rio Grande Do Sul
Study officials:
References:
citation: 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.