Clinical trial NCT02577744: Acute Effect of EPAP and Noninvasive Ventilation on Pulmonary Function and Lung Regional Ventilation on Bariatric Surgery
Official title: 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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Bariatric Surgery
Obesity
Physical Therapy Modalities
Keywords: Electrical Impedance Tomography
Lead sponsor: Universidade Federal de Pernambuco
Sponsor class: OTHER
First posted: 2015-10-16
Enrollment: 30
Sex: ALL
Minimum age (years): 20
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Regional Pulmonary Ventilation
timeFrame: six months
Secondary outcomes:
measure: Effects of bariatric surgery on respiratory muscle strength
timeFrame: Six months
measure: Patient perception of evaluation and assessing the quality of postoperative recovery
timeFrame: Six months
measure: Effects of bariatric surgery on lung function
timeFrame: Six months
measure: Adverse effects of technical and EPAP NIV
timeFrame: Six months
measure: Therapeutic effect time of the EPAP and NIV
timeFrame: six months
Other outcomes:
Locations:
city: Recife
country: Brazil
facility: Hospital das Clínicas
state: Pernambuco
Study officials:
References: