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Clinical Trials/NCT02577744
NCT02577744
Unknown
Not Applicable

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

Universidade Federal de Pernambuco1 site in 1 country30 target enrollmentOctober 2015

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Bariatric Surgery
Sponsor
Universidade Federal de Pernambuco
Enrollment
30
Locations
1
Primary Endpoint
Regional Pulmonary Ventilation
Last Updated
8 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
October 2015
End Date
December 2018
Last Updated
8 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Sóstynis José de Albuquerque Silva

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

Universidade Federal de Pernambuco

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.

Outcomes

Primary Outcomes

Regional Pulmonary Ventilation

Time Frame: 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 Outcomes

  • Effects of bariatric surgery on respiratory muscle strength(Six months)
  • Patient perception of evaluation and assessing the quality of postoperative recovery(Six months)
  • Effects of bariatric surgery on lung function(Six months)
  • Adverse effects of technical and EPAP NIV(Six months)
  • Therapeutic effect time of the EPAP and NIV(six months)

Study Sites (1)

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