跳至主要内容
临床试验/NCT03027180
NCT03027180已完成不适用

DIFFERENT LEVELS OF NONINVASIVE POSITIVE AIRWAY PRESSURE FOR LUNG EXPANSION ON PATIENTS WITH PLEURAL DRAINAGE: A STUDY VIA COMPUTED TOMOGRAPHY

Universidade Cidade de Sao Paulo0 个研究点目标入组 4 人开始时间: 2016年11月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
4
主要终点
Lung area

研究概览

简要总结

Question: What level of noninvasive positive airway pressure is able to expand the lungs of people with pleural drainage? Design: Cross-sectional, experimental and randomized study. Participants: Four consecutive people with pleural effusion drained within 24 hours, with controlled pain and without contraindications to use of noninvasive positive pressure. Intervention: Each person will be randomly subjected to three levels of noninvasive positive airway pressure: 0 (zero), 4 and 15 cmH2O for evaluation via chest computed tomography. Outcome measures: Lung area.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Treatment
盲法
Single (Outcomes Assessor)

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •age over 18 years
  • •presence of pleural drainage after traumatic hemothorax
  • •thoracic drainage within 24 hours
  • •controlled pain (below 3 points in the visual numeric scale, varying from zero to ten)

排除标准

  • •contraindication for use of noninvasive positive pressure in the airways, such as reduced level of consciousness (drowsiness, agitation or confusion), use of vasoactive drugs, complex arrhythmias, upper airway obstruction or trauma in the face, esophagus or upper airway, ineffective cough, inability to swallow, distended abdomen, nausea, vomiting, upper gastrointestinal bleeding
  • •previous application of any sort of lung expansion technique after thoracic drainage.

研究组 & 干预措施

0 (zero) cmH2O

Active Comparator

After draining, people will be asked about the level of pain via visual numeric scale and then subjected to chest computed tomography (Aquilion 64-Toshiba Medical Systems®, Japan), using positive airway pressure in the airways with 0 cmH2O

干预措施: Noninvasive positive airway pressure with different levels (Device)

4 cmH2O

Experimental

After draining, people will be asked about the level of pain via visual numeric scale and then subjected to chest computed tomography (Aquilion 64-Toshiba Medical Systems®, Japan), using positive airway pressure in the airways with 4 cmH2O

干预措施: Noninvasive positive airway pressure with different levels (Device)

15 cmH2O

Experimental

After draining, people will be asked about the level of pain via visual numeric scale and then subjected to chest computed tomography (Aquilion 64-Toshiba Medical Systems®, Japan), using positive airway pressure in the airways with 15 cmH2O

干预措施: Noninvasive positive airway pressure with different levels (Device)

结局指标

主要结局

Lung area

时间窗: 20 seconds after pressure application

次要结局

未报告次要终点

研究者

发起方
Universidade Cidade de Sao Paulo
申办方类型
Other
责任方
Principal Investigator
主要研究者

Adriana Claudia Lunardi

Professor

Universidade Cidade de Sao Paulo

相似试验

Pressure Levels on Lung Expansion | 临床试验