跳至主要内容
临床试验/NCT02577744
NCT02577744Unknown不适用

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 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2015年10月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
入组人数
30
试验地点
1
主要终点
Regional Pulmonary Ventilation

研究概览

简要总结

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Triple (Participant, Investigator, Outcomes Assessor)

入排标准

年龄范围
20 Years 至 50 Years(Adult)
性别
All
接受健康志愿者
否

入选标准

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

排除标准

  • •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.

研究组 & 干预措施

Expiratory Positive Air Pressure

Active Comparator

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

干预措施: Noninvasive Ventilation (Other)

Expiratory Positive Air Pressure

Active Comparator

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

干预措施: Expiratory Positive Air Pressure (Other)

Noninvasive Ventilation

Active Comparator

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.

干预措施: Noninvasive Ventilation (Other)

Noninvasive Ventilation

Active Comparator

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.

干预措施: Expiratory Positive Air Pressure (Other)

结局指标

主要结局

Regional Pulmonary Ventilation

时间窗: 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.

次要结局

  • 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)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

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

研究点 (1)

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