Effects of the Breath Stacking Technique After Upper Abdominal Surgery

NCT04418700 | Completed DMC

• 1 other identifier: 11041019.0.0000.5346
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

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.

Conditions

Abdominal Surgery

Keywords

surgery; abdomen; pulmonary ventilation; physical therapy techniques

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (15)

• Heart rate

  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

  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

  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 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

  It will be evaluated on the 2nd postoperative day and up to 7th postoperative day.

Study Arms (2)

Breath Stacking technique

EXPERIMENTAL

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

Routine physical therapy

NO INTERVENTION

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.

Interventions

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.

Breath Stacking technique

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients undergoing a surgical procedure that involves in an incision in the upper quadrants of the abdominal region.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Universidade Federal de Santa Maria: lead

Study Sites (1)

Federal University of Santa Maria

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

Location

Related Publications (1)

• 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.

  PMID: 35293484 DERIVED

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: May 21, 2020
• First Posted: June 5, 2020
• Study Start: June 1, 2020
• Primary Completion: March 31, 2021
• Study Completion: March 31, 2021
• Last Updated: April 26, 2021

Record last verified: 2021-04

Locations

BR (1)