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

This study has been completed.
Sponsor:
Information provided by:
Universidade Metodista de Piracicaba
ClinicalTrials.gov Identifier:
NCT00678678
First received: April 29, 2008
Last updated: May 13, 2008
Last verified: April 2008
History of Changes
  Purpose

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 Intervention
Obesity
 Device: Incentive Spirometry - RESPIRON
Device: Kit Epap®:

Study Type: Interventional
Official Title: Chest Physiotherapy After Bariatric Surgery - a Comparison Between Incentive Spirometry and Epap

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Universidade Metodista de Piracicaba:

Primary Outcome Measures:
  • spirometry, thoracoabdominal (cirtometry) and diaphragmatic motion [ Time Frame: preoperative and second postoperative day ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Hospital stay and postoperative pulmonary complications
Arms Assigned Interventions
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

  Eligibility
Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Genders 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00678678

Locations
Brazil
Meridional Hospital
Cariacica, Espirito Santo, Brazil, 29101-000
Sponsors and Collaborators
Universidade Metodista de Piracicaba
  More Information

ClinicalTrials.gov Identifier: NCT00678678     History of Changes
Other Study ID Numbers: 01/07 
Study First Received: April 29, 2008
Last Updated: May 13, 2008
Health Authority: Brazil: National Committee of Ethics in Research

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

ClinicalTrials.gov processed this record on September 27, 2016