Acute Effect of EPAP and Noninvasive Ventilation on Pulmonary Function and Lung Regional Ventilation on Bariatric Surgery

NCT ID: NCT02577744

Last Updated: 2018-01-03

Study Results

Results pending

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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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-10-31

Study Completion Date

2018-12-31

Brief Summary

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Obesity is a non-communicable chronic disease of multifactorial, involving biological, historical, ecological, economic, social, cultural and political. Currently, bariatric surgery is considered an effective method of refractory obesity treatment, and only severe obesity effective treatment that leads to reduced long-term weight. It is well documented in the literature regarding the association of abdominal surgery and the incidence of respiratory complications and its main characteristics are: atelectasis, pneumonia, respiratory dysfunction and pleural effusion. All these respiratory complications can be minimized or avoided with the use of a respiratory therapy care protocol, since the pulmonary atelectasis is considered the main cause of complications. An arsenal of resources to physical therapy lung expansion, among these, the application of positive pressure through a valve EPAP (Expiratory positive airway Pressure) and the use of noninvasive ventilation, and aims to prevent and / or improve the complications resulting from postoperative. The electrical impedance tomography (EIT) is an alternate to allow assessment of the respiratory system, without suffering the same interference conditions of patients, such as pain and bed rest. TIE consists of a method that measures passively regional lung ventilation. The aim of this study is to compare the effects of the application of EPAP and NIV on pulmonary ventilation we post bariatric surgery. This is a randomized controlled trial where patients will be divided into two groups: EPAP and NIV and assessed by spirometry, manometer and TIE. The techniques will be applied in the 1st and 2nd postoperative day where they will be evaluated before, during and after the application of the techniques.

Detailed Description

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Conditions

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Bariatric Surgery Obesity Physical Therapy Modalities

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Noninvasive Ventilation

Noninvasive ventilation for 15 minutes with EPAP set at 10 cmH2O and IPAP adjusted to maintain a tidal volume of 6 ml / kg ideal weight.

Group Type ACTIVE_COMPARATOR

Noninvasive Ventilation

Intervention Type OTHER

Noninvasive ventilation for 15 minutes with EPAP set at 10 cmH2O and IPAP adjusted to maintain a tidal volume of 6 ml / kg ideal weight.

Expiratory Positive Air Pressure

Intervention Type OTHER

EPAP through facial mask with valve spring load for 15 minutes set at 10 cmH2O.

Expiratory Positive Air Pressure

EPAP through facial mask with valve spring load for 15 minutes set at 10 cmH2O.

Group Type ACTIVE_COMPARATOR

Noninvasive Ventilation

Intervention Type OTHER

Noninvasive ventilation for 15 minutes with EPAP set at 10 cmH2O and IPAP adjusted to maintain a tidal volume of 6 ml / kg ideal weight.

Expiratory Positive Air Pressure

Intervention Type OTHER

EPAP through facial mask with valve spring load for 15 minutes set at 10 cmH2O.

Interventions

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Noninvasive Ventilation

Noninvasive ventilation for 15 minutes with EPAP set at 10 cmH2O and IPAP adjusted to maintain a tidal volume of 6 ml / kg ideal weight.

Intervention Type OTHER

Expiratory Positive Air Pressure

EPAP through facial mask with valve spring load for 15 minutes set at 10 cmH2O.

Intervention Type OTHER

Other Intervention Names

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NIV EPAP

Eligibility Criteria

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Inclusion Criteria

* Patients undergoing bariatric surgery, of both sexes and aged between 20 and 50 years.

Exclusion Criteria

* severe lung disease;
* patients with congestive heart failure (NYHA Class III or IV);
* coronary artery disease;
* presented hemodynamic instability (MAP \<60 mmHg) or arrhythmias during the performance of techniques, plus any contraindications to perform the BS techniques, EPAP and NIV to consider: Trauma / facial injury that prevents the attachment of the mask, extreme anxiety, hypotension and lack of patient cooperation.
Minimum Eligible Age

20 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Universidade Federal de Pernambuco

OTHER

Sponsor Role lead

Responsible Party

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Sóstynis José de Albuquerque Silva

Acute Effect of Epap and Noninvasive Ventilation on Pulmonary Function and Lung Regional Ventilation on Bariatric Surgery

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Hospital das Clínicas

Recife, Pernambuco, Brazil

Site Status RECRUITING

Countries

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Brazil

Central Contacts

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Sóstynis JA Silva, Mastering

Role: CONTACT

+558199750784

Armele FD Andrade, Doctor

Role: CONTACT

Facility Contacts

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Célia Castro, Teaching and Research Manager

Role: primary

+5581 2126 3984

Other Identifiers

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38032414.3.0000.5208

Identifier Type: -

Identifier Source: org_study_id

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