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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00678678
Other study ID # 01/07
Secondary ID
Status Completed
Phase N/A
First received April 29, 2008
Last updated May 13, 2008

Study information

Verified date April 2008
Source Universidade Metodista de Piracicaba
Contact n/a
Is FDA regulated No
Health authority Brazil: National Committee of Ethics in Research
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 0
Est. completion date
Est. primary completion date
Accepts healthy volunteers No
Gender Female
Age group 18 Years to 65 Years
Eligibility 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

Study Design

N/A


Related Conditions & MeSH terms


Intervention

Device:
Incentive Spirometry - RESPIRON
Device that stimulates the deep breathing, flow-oriented
Kit Epap®:
Device that providing constant positive pressure during expiration, given by spring load (cmH2O), using a face mask as an interface

Locations

Country Name City State
Brazil Meridional Hospital Cariacica Espirito Santo

Sponsors (1)

Lead Sponsor Collaborator
Universidade Metodista de Piracicaba

Country where clinical trial is conducted

Brazil, 

Outcome

Type Measure Description Time frame Safety issue
Primary spirometry, thoracoabdominal (cirtometry) and diaphragmatic motion preoperative and second postoperative day Yes
Secondary Hospital stay and postoperative pulmonary complications
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