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Incentive Spirometry and Breath Stacking

NCT02054039 · Status: UNKNOWN · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 118

Last updated 2014-02-25

No results posted yet for this study

Summary

\- Postoperative pulmonary complications in patients undergoing cardiac surgery are a major clinical problem, presenting negative impact on morbidity, mortality , length of hospital stay and health care costs. Although physical therapy has been widely used as a resource to improve lung function in the postoperative period, the adoption of routine procedures of physical therapy needs be discussed.

* Incentive spirometers are mechanical devices used to reduce postoperative pulmonary complications. In general, they are activated by an inspiratory effort, visualized by an uplifted plate or ball in a transparent cylinder during sustained inspiration.
* Breath Stacking is a technique allowing the patient inhale a greater volume of air, kept for a longer period of time using a one-way valve, thus promoting the accumulation of successive inspiratory volume and preventing exhalation.
* The objective of the study is to evaluate the effectiveness of two different techniques of respiratory therapy on both reducing postoperative pulmonary complications and improving lung function.
* Type of study : randomized clinical trial
* Hypothesis

1. Both techniques Trifllo II Incentive Spirometry ( IS) (Trifllo ® - II ) and Breath Stacking ( BS ) may present similar effectiveness on reducing pulmonary complications, improving lung function and respiratory muscle strength ( MIP and MEP), as well as reducing hospital stay .
2. Trifllo II Incentive Spirometry ( IS) (Trifllo ® - II ) may be more effective than Breath Stacking on reducing pulmonary complications, improving lung function and respiratory muscle strength, as well as reducing hospital stay.

Conditions

  • Postoperative Complications

Interventions

DEVICE

Incentive spirometry (IS)

Mechanical devices activated by an inspiratory effort, which is viewed by the elevation of a plateau or balls in a transparent cylinder having a calibrated scale that displays the inspired flow.

DEVICE

Breath Stacking (BS)

Equipment with a one-way valve that masks and promotes the accumulation of successive inspiratory volumes, preventing expiration

Sponsors & Collaborators

  • Federal University of São Paulo

    lead OTHER

Principal Investigators

  • Eliane Freitas, PhD · Federal University of São Paulo and University of Northern Parana

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-02-28
Primary Completion
2014-07-31
Completion
2014-12-31

Countries

  • Brazil

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02054039 on ClinicalTrials.gov