- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03042403
Effects of the Breath Stacking Technic in Healthy Individuals
February 1, 2017 updated by: Luciene Aparecida José Vaz, Federal University of Uberlandia
This study aims to Analyze and compere the hemodynamic and respiratory variables before, during and after the applying of technic as well as evaluate respiratory pressures generated during applying of this same technic and correlate them with the effort noticed by device user.
Study Overview
Detailed Description
The breath stacking technic (BS) is an inspiratory maneuver used for recruitment of collapsed alveoli and, consequently, improves oxygenation and, therefore, used by respiratory physiotherapy aiming promoting lung re-expansion being.
The BS was described by Marini as an attempt of optimizing vital capacity in little co-operative individuals and hemodynamics has been considered a way of incentive spirometry that provides high lung volume, in situations, in which, inspiratory maneuver duration can be as important as the volume reached, composing an alternative incentive of inspiration technic4.
The system used is composed by an interface (facial mask) connected to the patient, an inspiratory unidirectional valve and the respiratory branch which is kept occluded during the carrying out of maneuvers.
Study Type
Observational
Enrollment (Actual)
52
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 30 years (Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
52 healthy young volunteers The volunteers at the age of 18 to 30, sedentary: absence of neuromuscular and/or cardiac respiratory diseases were included, the smokers, overweight, claustrophobic or the ones with difficulty in carrying out the technic were excluded
Description
Inclusion Criteria:
- age of 18 to 30, sedentary, absence of neuromuscular and/or cardiac respiratory diseases
Exclusion Criteria:
- the smokers, overweight, claustrophobic or the ones with difficulty in carrying out the technic
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Breath stacking
During initial rest period, the volunteer remained seated for 10' in spontaneous breathing.
During carrying out of the breath stacking technic, the volunteer remained seated, being requested to hold the mask on his/her face not allowing air scape, The volunteer was oriented to inhale normally and exhale all the air during expiration for 20 seconds.
During the 20 seconds of applying of technic, in the three series the maximum inspiratory and expiratory pressures reached during the carrying out of technic.
In the final rest period, right after technic end, the volunteers remained seated for 10 minutes in spontaneous breathing and again the same variables of control at the 10th minute were assessed.
|
During initial rest period, the volunteer remained seated for 10' in spontaneous breathing.
Right after, the measurement of arterial pressure, of SpO2 (%), of heart rate, of respiratory frequency and applied to a modified effort perception Borg.
During carrying out of the breath stacking technic, the volunteer remained seated, being requested to hold the mask on his/her face not allowing air scape, The volunteer was oriented to inhale normally and exhale all the air during expiration for 20 seconds, and the variables were assessement again the same variables of control.
In the final rest period, right after technic end, the volunteers remained seated for 10 minutes in spontaneous breathing and again the same variables of control at the 10th minute were assessed.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
maximum inspiratory and expiratory pressures
Time Frame: During the intervention. They will be used to verify the average pressures generated during the execution of the technique. Time of the technique equal to 20 seconds.
|
connected to a manometer from brand Commercial Medica (Brazil) used to measure maximum inspiratory and expiratory pressures generated during carrying out of technic.
The volunteer was oriented to inhale normally and exhale all the air during expiration for 20 seconds.
|
During the intervention. They will be used to verify the average pressures generated during the execution of the technique. Time of the technique equal to 20 seconds.
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
modified effort perception Borg scale
Time Frame: Before, during and after the intervention. They will be used to compare the variation before, during and after the technique. Valuation time was 1 minute.
|
applied to a modified effort perception Borg scale with a score from 0 to 10, considering 0 the smallest effort noticed and 10 the biggest effort reported
|
Before, during and after the intervention. They will be used to compare the variation before, during and after the technique. Valuation time was 1 minute.
|
|
heart rate
Time Frame: Before, during and after the intervention. They will be used to compare the variation before, during and after the technique. Valuation time was 1 minute.
|
by palpation method of radial artery, of respiratory frequency by direct counting of thoracic movement
|
Before, during and after the intervention. They will be used to compare the variation before, during and after the technique. Valuation time was 1 minute.
|
|
peripheral oxygen saturation
Time Frame: Before, during and after the intervention. They will be used to compare the variation before, during and after the technique. Valuation time was 1 minute.
|
through a pulse oximeter
|
Before, during and after the intervention. They will be used to compare the variation before, during and after the technique. Valuation time was 1 minute.
|
|
systolic arterial pressure
Time Frame: Before, during and after the intervention. They will be used to compare the variation before, during and after the technique. Valuation time was 1 minute.
|
the measurement of systolic arterial pressure were assessed using an aneroid-type sphygmomanometer
|
Before, during and after the intervention. They will be used to compare the variation before, during and after the technique. Valuation time was 1 minute.
|
|
diastolic arterial pressure
Time Frame: Before, during and after the intervention. They will be used to compare the variation before, during and after the technique. Valuation time was 1 minute.
|
the measurement of systolic arterial pressure were assessed using an aneroid-type sphygmomanometer from the brand Lamedial Commercial
|
Before, during and after the intervention. They will be used to compare the variation before, during and after the technique. Valuation time was 1 minute.
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
October 1, 2012
Primary Completion (Actual)
January 1, 2013
Study Completion (Actual)
September 1, 2013
Study Registration Dates
First Submitted
January 24, 2017
First Submitted That Met QC Criteria
February 1, 2017
First Posted (Estimate)
February 3, 2017
Study Record Updates
Last Update Posted (Estimate)
February 3, 2017
Last Update Submitted That Met QC Criteria
February 1, 2017
Last Verified
February 1, 2017
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- CEP/UFU 364/11
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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