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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03042403
Other study ID # CEP/UFU 364/11
Secondary ID
Status Completed
Phase N/A
First received January 24, 2017
Last updated February 1, 2017
Start date October 2012
Est. completion date September 2013

Study information

Verified date February 2017
Source Federal University of Uberlandia
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 52
Est. completion date September 2013
Est. primary completion date January 2013
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 30 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Other:
Breath stacking
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.

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Federal University of Uberlandia

Outcome

Type Measure Description Time frame Safety issue
Primary 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. 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 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 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.
Secondary heart rate 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.
Secondary peripheral oxygen saturation 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.
Secondary systolic arterial pressure 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.
Secondary diastolic arterial pressure 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.
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