NCT00678678

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.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 29, 2008

Completed
16 days until next milestone

First Posted

Study publicly available on registry

May 15, 2008

Completed
Last Updated

May 15, 2008

Status Verified

April 1, 2008

First QC Date

April 29, 2008

Last Update Submit

May 13, 2008

Conditions

Keywords

PhysiotherapyBreathing exercisesBariatric SurgeryLaparoscopy

Outcome Measures

Primary Outcomes (1)

  • spirometry, thoracoabdominal (cirtometry) and diaphragmatic motion

    preoperative and second postoperative day

Secondary Outcomes (1)

  • Hospital stay and postoperative pulmonary complications

Study Arms (2)

I - Spirometer

ACTIVE COMPARATOR
Device: Incentive Spirometry - RESPIRON

II - Kit Epap®

ACTIVE COMPARATOR

Device with Spring load by mask,produced by Brazil (critical med)

Device: Kit Epap®:

Interventions

Device that stimulates the deep breathing, flow-oriented

I - Spirometer

Device that providing constant positive pressure during expiration, given by spring load (cmH2O), using a face mask as an interface

Also known as: EPAP - End positive airway pressure, Spring Load by mask
II - Kit Epap®

Eligibility Criteria

Age18 Years - 65 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • Unable to perform the evaluation tests
  • Not signed the consentment term

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Meridional Hospital

Cariacica, Espírito Santo, 29101-000, Brazil

Location

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Sponsor Type
OTHER

Study Record Dates

First Submitted

April 29, 2008

First Posted

May 15, 2008

Last Updated

May 15, 2008

Record last verified: 2008-04

Locations