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临床试验/NCT04059614
NCT04059614已完成不适用

Comparison of High-Flow Nasal Cannula (HFNC) and Conventional Oxygen Therapy (COT) to Diaphragm Function of Post-Upper Abdominal Surgery Patients

Indonesia University1 个研究点 分布在 1 个国家目标入组 66 人开始时间: 2019年9月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
66
试验地点
1
主要终点
diaphragm thickness

研究概览

简要总结

This study aims to compare diaphragm thickness, air lung distribution, and several clinical and laboratory parameters on post abdominal surgery patients with conventional oxygen therapy vs high-flow nasal cannula

详细描述

"Approval from Ethical Committee of Faculty of Medicine Universitas Indonesia was acquired prior conducting the study. Subjects were recruited using consecutive sampling method. Subjects underwent upper-abdominal surgery were screened. Eligible and consented subjects were randomized into intervention group (high-flow nasal cannula) and control group (conventional oxygen therapy). Subject and operation characteristics were recorded prior to intervention.

Clinical parameters (vital signs, Borg Score, ICON) were recorded in 10 specific times. diaphragm thickness data using abdominal ultrasonography (USG) and air lung distribution data using Electrical Impedance Tomography were collected in 7 specific times while lactate and blood gas analysis were done 4 times. "

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
None

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • patients from 18 - 65 yrs old,
  • American Society of Anaesthesia (ASA) status I-III,
  • BMI < 30, patent airway,
  • Measurement of Exercise Tolerance before Surgery (METS) Score > 4,
  • P-POSSUM score <10%,
  • agreed to the study

排除标准

  • uncooperative subjects,
  • DNR (do not resuscitate) patients,
  • patients with tracheostomy, pleural effusion, pneumothorax or pulmonary atelectasis

结局指标

主要结局

diaphragm thickness

时间窗: 2 months

diaphragm thickness are measured sequentially by abdominal ultrasonography (mm)

次要结局

  • respiratory rate(2 months)
  • ICON(2 months)
  • heart rate(2 months)
  • mean arterial pressure(2 months)
  • lactate(2 months)
  • partial 02 pressure(2 months)
  • electrical impedance tomography (EIT) data(2 months)
  • partial carbondioxyde pressure(2 months)

研究者

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

Sidharta K. Manggala

Consultant, Anesthesiologist

Indonesia University

研究点 (1)

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