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

Not Applicable

• Conditions: Bariatric Surgery; Obesity; Physical Therapy Modalities
• Interventions: Other: Noninvasive Ventilation; Other: Expiratory Positive Air Pressure

• Registration Number: NCT02577744
• Lead Sponsor: Universidade Federal de Pernambuco

Brief Summary

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

Not available

Study Timeline

• Study Start: 2015-10
• Study First Submitted: 2015-10-12
• Study First Submitted QC: 2015-10-13
• Study First Posted: 2015-10-16
• Status Verified: 2017-12
• Last Update Submitted: 2017-12-29
• Primary Completion: 2018-01
• Last Update Posted: 2018-01-03
• Study Completion: 2018-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 30

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Noninvasive Ventilation	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.
Noninvasive Ventilation	Expiratory Positive Air Pressure	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	Expiratory Positive Air Pressure	EPAP through facial mask with valve spring load for 15 minutes set at 10 cmH2O.
Expiratory Positive Air Pressure	Noninvasive Ventilation	EPAP through facial mask with valve spring load for 15 minutes set at 10 cmH2O.

Primary Outcome Measures

Name	Time	Method
Regional Pulmonary Ventilation	six months	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.

Secondary Outcome Measures

Name	Time	Method
Effects of bariatric surgery on respiratory muscle strength	Six months	Assessment of maximum inspiratory pressure by manometer before and after bariatric surgery .
Patient perception of evaluation and assessing the quality of postoperative recovery	Six months	Evaluation by applying the Global Quality of recovery -40 questionnaire (QoR -40) at 24 and 48 hours after the surgical procedure.
Effects of bariatric surgery on lung function	Six months	Evaluation by spirometry, considering the variables, CV, FEV1, FVC, PEF, FEV1/FVC, FEF 25-75 %.
Adverse effects of technical and EPAP NIV	Six months	Through evaluation of open questions about the occurrence of adverse effects during the technique, such as headache, nausea, dizziness, discomfort, nausea and vomiting.
Therapeutic effect time of the EPAP and NIV	six months	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.

Trial Locations

Locations (1)

Hospital das Clínicas; 🇧🇷 Recife, Pernambuco, Brazil