Hemodynamic InstabilityNCT03042403
Effects of the Breath Stacking Technic in Healthy Individuals
An observational study of Hemodynamic Instability, run by Federal University of Uberlandia.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 30 yearsHealthy volunteers can take part
- Conditions the study is for
- Hemodynamic Instability
- What is being tested?
- Breath stacking
- How many people
- 52 participants
- Where
- No sites listed yet
- Study dates
- Oct 2012to Sep 2013
- Phase
- Observational
- 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 30 years
- All sexes
- Healthy volunteers accepted
- Adult
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
Who may be able to join
- age of 18 to 30, sedentary, absence of neuromuscular and/or cardiac respiratory diseases
Who cannot join
- the smokers, overweight, claustrophobic or the ones with difficulty in carrying out the technic
About this study
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.
Read the 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.
- Conditions
- Hemodynamic Instability
- Being tested
- Breath stacking
- Keywords
- hemodynamics, physiotherapy, breath stacking
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Breath stackingOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Breath stacking |
What is being measured
The primary outcome is the main question the study is designed to answer.
maximum inspiratory and expiratory pressures
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.
Measured: 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 outcomes (5)
modified effort perception Borg scale
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
Measured: 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
by palpation method of radial artery, of respiratory frequency by direct counting of thoracic movement
Measured: 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
through a pulse oximeter
Measured: 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
the measurement of systolic arterial pressure were assessed using an aneroid-type sphygmomanometer
Measured: 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
the measurement of systolic arterial pressure were assessed using an aneroid-type sphygmomanometer from the brand Lamedial Commercial
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Feb 2017 (estimated)
- Study startOct 2012
- Primary completionJan 2013
- Study completionSep 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hemodynamic InstabilityStudies 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
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- Federal University of Uberlandia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Luciene Aparecida José Vaz, Federal University of Uberlandia
- Investigators
- Celia R Lopes, Principal investigator, Federal University of Uberlandia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03042403
- Sponsor's protocol ID
- CEP/UFU 364/11
- Status last verified
- Feb 2017
- First submitted
- 24 Jan 2017
- Last updated
- 3 Feb 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of the Breath Stacking Technic in Healthy Individuals
- ClinicalTrials.gov ID
- NCT03042403
- Acronym / sponsor ID
- CEP/UFU 364/11
- Conditions
- Hemodynamic Instability
- Keywords
- hemodynamics, physiotherapy, breath stacking
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- Federal University of UberlandiaUniversity, hospital or other
- Study start
- Oct 2012
- Primary completion
- Jan 2013 (actual)
- Study completion
- Sep 2013 (actual)
- First posted
- 3 Feb 2017 (estimated)
- 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 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.
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 design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Breath stacking | – | Other: Breath stackingDuring 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. |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- 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
Key inclusion criteria (1 listed)
- age of 18 to 30, sedentary, absence of neuromuscular and/or cardiac respiratory diseases
Key exclusion criteria (1 listed)
- the smokers, overweight, claustrophobic or the ones with difficulty in carrying out the technic
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 stackingDuring 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. | Other | Breath stacking |
Primary outcome
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.
5 secondary outcomes
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.
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.
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.
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.
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.
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 3 Feb 2017.
- Individual participant dataSharing planned: No
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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.
Celia R Lopes principal investigator
Federal University of Uberlandia
Questions about this trial
What is this clinical trial studying?
An observational study of Hemodynamic Instability, run by Federal University of Uberlandia.
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 1 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 3 Feb 2017. Status can change between updates, so confirm with the study contact before making plans.
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?
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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 3 Feb 2017.