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

Study Overview
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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.

Official Title
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Acute Effect of EPAP and Noninvasive Ventilation on Pulmonary Function, Regional Lung Ventilation and Respiratory Mechanics on Patients Submitted Bariatric Surgery Evaluated by Spirometry and Electric Impedance Tomography: A Clinical Trial Controlled Randomized

Conditions
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Bariatric Surgery, Obesity, Physical Therapy Modalities

Intervention / Treatment
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* Other: Noninvasive Ventilation
* Other: Expiratory Positive Air Pressure


Participation Criteria
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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.

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Noninvasive Ventilation<br>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. | Other: Noninvasive Ventilation<br>* 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.<br>* Other names: NIV;Other: Expiratory Positive Air Pressure<br>* EPAP through facial mask with valve spring load for 15 minutes set at 10 cmH2O.<br>* Other names: EPAP;|
| Active Comparator: Expiratory Positive Air Pressure<br>EPAP through facial mask with valve spring load for 15 minutes set at 10 cmH2O. | Other: Noninvasive Ventilation<br>* 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.<br>* Other names: NIV;Other: Expiratory Positive Air Pressure<br>* EPAP through facial mask with valve spring load for 15 minutes set at 10 cmH2O.<br>* Other names: EPAP;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Regional Pulmonary Ventilation | Assessment of regional ventilation through the variables of electrical impedance tomography , Delta Z (impedance variation) in the anterior and posterior region, and right and left lung. | six months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Effects of bariatric surgery on respiratory muscle strength | Assessment of maximum inspiratory pressure by manometer before and after bariatric surgery . | Six months | 
| Patient perception of evaluation and assessing the quality of postoperative recovery | Evaluation by applying the Global Quality of recovery -40 questionnaire (QoR -40) at 24 and 48 hours after the surgical procedure. | Six months | 
| Effects of bariatric surgery on lung function | Evaluation by spirometry, considering the variables, CV, FEV1, FVC, PEF, FEV1/FVC, FEF 25-75 %. | Six months | 
| Adverse effects of technical and EPAP NIV | Through evaluation of open questions about the occurrence of adverse effects during the technique, such as headache, nausea, dizziness, discomfort, nausea and vomiting. | Six months | 
| Therapeutic effect time of the EPAP and NIV | Quantify the therapeutic effect of time of the technical EPAP and NIV by analyzing the variables of the impedance electrical tomography , Average electrical impedance at the end of expiration (MIEFE) and monitoring this baseline during the post technique period at times 5 and 30 minutes post intervention. | six months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Electrical Impedance Tomography