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Chest Physiotherapy After Bariatric Aurgery - A Comparison Between Incentive Spirometry and Expiratory Positive Airway Pressure (Epap)

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ClinicalTrials.gov Identifier: NCT00678678
Recruitment Status : Completed
First Posted : May 15, 2008
Last Update Posted : May 15, 2008
Sponsor:
Information provided by:
Universidade Metodista de Piracicaba

Study Description
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:

Objective: To compare the effects of the EPAP and the incentive spirometry flow-oriented in the pulmonary function after bariatric surgery.

Method: Twenty-eight women, non-smokers, with no lung disease and BMI of 35-49,99 kg/m2, undergoing bariatric surgery by laparoscopy, were studied. Before surgery the patients were divided in two groups: Spirometer Group (SG) (n=13) and EPAP Group (EG) (n=15). Pulmonary function was evaluated by spirometry, thoracoabdominal (cirtometry) and diaphragmatic motion, on the preoperative and on the second postoperative day. Physiotherapy started on the day of surgery, each modality (incentive spirometry or EPAP) performed lasting 15 minutes. The deambulation and active exercises of upper and lower limbs were standardized for groups.


Condition or disease Intervention/treatment Phase
Obesity Device: Incentive Spirometry - RESPIRON Device: Kit Epap®: Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Official Title: Chest Physiotherapy After Bariatric Surgery - a Comparison Between Incentive Spirometry and Epap

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Arms and Interventions
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Arm Intervention/treatment
Active Comparator: I - Spirometer Device: Incentive Spirometry - RESPIRON
Device that stimulates the deep breathing, flow-oriented
Active Comparator: II - Kit Epap®
Device with Spring load by mask,produced by Brazil (critical med)
 Device: Kit Epap®:
Device that providing constant positive pressure during expiration, given by spring load (cmH2O), using a face mask as an interface
Other Names:
  • EPAP - End positive airway pressure
  • Spring Load by mask


Outcome Measures
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Primary Outcome Measures :
  1. spirometry, thoracoabdominal (cirtometry) and diaphragmatic motion [ Time Frame: preoperative and second postoperative day ]

Secondary Outcome Measures :
  1. Hospital stay and postoperative pulmonary complications

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Obese with body mass index between: 35 e 50 kg/m2
  • Non-smokers
  • No lung disease

Exclusion Criteria:

  • Unable to perform the evaluation tests
  • Not signed the consentment term
Contacts and Locations
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00678678


Locations
Brazil
Meridional Hospital
Cariacica, Espirito Santo, Brazil, 29101-000
Sponsors and Collaborators
Universidade Metodista de Piracicaba
More Information
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

ClinicalTrials.gov Identifier: NCT00678678     History of Changes
Other Study ID Numbers: 01/07
First Posted: May 15, 2008    Key Record Dates
Last Update Posted: May 15, 2008
Last Verified: April 2008

Keywords provided by Universidade Metodista de Piracicaba:
Physiotherapy
Breathing exercises
Bariatric Surgery
Laparoscopy