Abdominal SurgeryNCT04418700
Effects of the Breath Stacking Technique After Upper Abdominal Surgery
A study testing Breath Stacking in people with Abdominal Surgery, run by Universidade Federal de Santa Maria at 1 site in Brazil.
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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Abdominal Surgery
- What is being tested?
- Breath Stacking
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteBrazil
- Study dates
- 1 Jun 2020to 31 Mar 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients undergoing a surgical procedure that involves in an incision in the upper quadrants of the abdominal region.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Federal University of Santa Maria
Santa Maria, Rio Grande do Sul, 97105-900
About this study
Official title: 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.
Read the 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.
- Conditions
- Abdominal Surgery
- Being tested
- Breath Stacking
- Keywords
- surgery, abdomen, pulmonary ventilation, physical therapy techniques
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Breath StackingDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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 with portable pulse oximeter.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jun 2020
- Study start1 Jun 2020
- Primary completion31 Mar 2021
- Study completion31 Mar 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Abdominal SurgeryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidade Federal de Santa Maria
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Prof. Dr. Antônio Marcos Vargas da Silva, Universidade Federal de Santa Maria
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04418700
- Sponsor's protocol ID
- 11041019.0.0000.5346
- Status last verified
- Apr 2021
- First submitted
- 21 May 2020
- Last updated
- 26 Apr 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
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.
PubMed 35293484
Study at a glance
From the registry record, last updated by the sponsor on 26 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of the Breath Stacking Technique After Upper Abdominal Surgery: Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04418700
- Acronym / sponsor ID
- 11041019.0.0000.5346
- Conditions
- Abdominal Surgery
- Keywords
- surgery, abdomen, pulmonary ventilation, physical therapy techniques
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Universidade Federal de Santa MariaUniversity, hospital or other
- Study start
- 1 Jun 2020 (actual)
- Primary completion
- 31 Mar 2021 (actual)
- Study completion
- 31 Mar 2021 (actual)
- First posted
- 5 Jun 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Breath Stacking technique | Experimental | Device: Breath StackingThe 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. |
| 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients undergoing a surgical procedure that involves in an incision in the upper quadrants of the abdominal region.
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Breath StackingThe 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. | Device | Breath Stacking technique |
Primary outcome
Change from second postoperative day forced vital capacity (FVC) at 7th postoperative day or hospital discharge.
Time frame: The change in FVC will be evaluated on the 2nd postoperative day and up to 7th postoperative day.
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.
Change from second postoperative day tidal volume at 7th postoperative day or hospital discharge.
Time frame: The change in tidal volume will be evaluated on the 2nd postoperative day and up to 7th postoperative day.
Tidal volume will be obtained through the division of the minute volume by the respiratory rate.
15 secondary outcomes
Heart rate
Time frame: 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
Time frame: 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
Time frame: 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)
Time frame: 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
Time frame: It will be evaluated on the 2nd postoperative day and up to 7th postoperative day.
Thoracoabdominal mobility
Time frame: It will be evaluated on the 2nd postoperative day and up to 7th postoperative day.
Minute volume
Time frame: It will be evaluated on the 2nd postoperative day and up to 7th postoperative day.
Forced expiratory volume in the first second (FEV1)
Time frame: It will be evaluated on the 2nd postoperative day and up to 7th postoperative day.
FEV1 / FVC ratio (FEV1 / FVC)
Time frame: It will be evaluated on the 2nd postoperative day and up to 7th postoperative day.
Peak expiratory flow (PEF)
Time frame: 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)
Time frame: It will be evaluated on the 2nd postoperative day and up to 7th postoperative day.
Respiratory muscle strength
Time frame: These will be evaluated on the 2nd postoperative day and up to 7th postoperative day.
Degree of dyspnea
Time frame: 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)
Time frame: 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)
Time frame: 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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Apr 2021.
- Derived from this study: PubMed 35293484Fernandes 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Breath Stacking in people with Abdominal Surgery, run by Universidade Federal de Santa Maria at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from second postoperative day forced vital capacity (FVC) at 7th postoperative day or hospital discharge. (time frame: The change in FVC will be evaluated on the 2nd postoperative day and up to 7th postoperative day.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04418700, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Apr 2021.