Use of Positive Pressure in Morbidly Obese Patients Undergoing Reduction Stomach Surgery
NCT ID: NCT01786681
Last Updated: 2013-02-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
40 participants
INTERVENTIONAL
2011-08-31
2011-12-31
Brief Summary
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It is believed that the application of these devices before, during or after surgery can help to improve the lungs and reduce pulmonary complications after surgery to reduce the stomach.
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Detailed Description
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Individuals with BMI between 40 and 55 kg/m2, aged between 25 and 55 years, were submitted to Roux-en-Y type gastric bypass by laparotomy. Patients showing a normal preoperative pulmonary function test were included, but those with hemodynamic instability, a hospital stay longer than three days or the presence of postoperative complications were excluded.
The volunteers were divided into four different groups:
Gpre: subjects treated with positive pressure in the BiPAP mode (Bi-Level Positive Airway Pressure) for one hour before surgery; Gpos: individuals treated with positive airway pressure (BiPAP) for one hour after surgery; Gpeep: individuals treated with 10 cm H2O of PEEP (Positive End Expiratory Pressure) during the surgical procedure.
Gcont: individuals treated with conventional physiotherapy (CP) according to the routine service of physiotherapy of the hospital, including the techniques of pulmonary re-expansion, breathing exercises (deep breaths or fractional), the use of incentive spirometry (Respiron®), bronchial hygiene resources if necessary (Flutter® and cough active or assisted) and assisted ambulation. It should be noted that the physiotherapist was blinded to the individual's participation in the groups, and all patients received conventional physiotherapy, independent of the group in which they were included.
The respiratory evaluation (preoperative and second postoperative days) consisted of collecting the anthropometric data, a pulmonary function test and a chest radiography (inspired and expired).
Conditions
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Study Design
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RANDOMIZED
FACTORIAL
TREATMENT
DOUBLE
Study Groups
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Positive pressure before surgery
Subjects treated with positive pressure in the BiPAP mode (Bi-Level Positive Airway Pressure) for one hour before bariatric surgery.
Positive pressure
Positive pressure during the surgery
Individuals treated with 10 cm H2O of PEEP (Positive End Expiratory Pressure) during the surgical procedure.
Positive pressure
Positive pressure after surgery
Subjects treated with positive pressure in the BiPAP mode (Bi-Level Positive Airway Pressure) for one hour after bariatric surgery.
Positive pressure
Control
Individuals treated with conventional physiotherapy according to the routine service of physiotherapy of the hospital.
No interventions assigned to this group
Interventions
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Positive pressure
Eligibility Criteria
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Inclusion Criteria
* Aged between 25 and 55 years
* Submitted to Roux-en-Y type gastric bypass by laparotomy
* Normal preoperative pulmonary function test
Exclusion Criteria
* Hospital stay longer than three days
* Presence of postoperative complications
25 Years
55 Years
ALL
Yes
Sponsors
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Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.
OTHER_GOV
Universidade Metodista de Piracicaba
OTHER
Responsible Party
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Eli Maria Pazzianotto Forti
PhD
Locations
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Universidade Metodista de Piracicaba (UNIMEP)
Piracicaba, São Paulo, Brazil
Countries
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Other Identifiers
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Leticia2011
Identifier Type: -
Identifier Source: org_study_id
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