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临床试验/NCT02363920
NCT02363920已完成4 期

Short Term Physiological Effects of Nasal High Oxygen Flow vs Low Oxygen Flow and Noninvasive Ventilation (NIV) on Respiratory Mechanics

IRCCS Azienda Ospedaliero-Universitaria di Bologna2 个研究点 分布在 1 个国家目标入组 14 人开始时间: 2015年3月最近更新:
适应症

试验速览

阶段
4 期
状态
已完成
入组人数
14
试验地点
2
主要终点
recording of respiratory mechanics

研究概览

简要总结

Nasal High Oxygen Flow (HOF) has been demonstrated to reduce the re-intubation rate in hypoxic patients and ameliorate breathing pattern in hypercapnic patients.

The aim of this study is to better understand the physiological mechanism underlying these results, assessing the respiratory mechanics in stable hypercapnic COPD patients.

详细描述

Subjects. 10 in-patients with stable COPD and chronic hypercapnic respiratory failure with no history of neurological or chronic cardiac disease will be recruited. They need to be in a phase of clinical stability and were for a short period of rehabilitation. Patients with X-ray evidence of pulmonary edema or congestion and pulmonary infiltrate will be excluded from the study. Written consent will be obtained from all subjects, and the protocol will be approved by the Ethics Committee.

Measurements. Static and dynamic lung volumes assessed by body plethysmography (MasterLab-Jaeger, Hochberg, Germany).

Flow measured with a pneumotachograph (Screenmate Box 0586, Jaeger GmbH, Hochberg, Germany), connected to a rigid mouthpiece.

Airway pressure measured through tubing inserted in the mouthpiece and connected to a differential pressure transducer (Honeywell 300 cm H2O, Freeport, IL, USA). VT obtained by integration of the flow signal. The inspiratory (TI), expiratory (TE) and total breathing cycle (TTOT) duration, respiratory frequency (RR), and duty cycle (TI/TTOT) calculated as average values of 10 consecutive breaths, after 5 minutes of breathing.

Baseline from peak changes in esophageal (Pes), gastric (Pga), and transdiaphragmatic (Pdi) pressures measured using the balloon-catheter technique. Pressure at the airway opening (Paw) measured via a side port.

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
Single (Participant)

入排标准

年龄范围
18 Years 至 85 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • COPD patients
  • Chronic hypercapnic respiratory failure (pH>7.34 and PaCO2>45 mmHg)

排除标准

  • Neurological and cardiac disease

结局指标

主要结局

recording of respiratory mechanics

时间窗: 30 minutes per arm

Respiratory mechanics will be assessed using Mead and Wittenberger's technique.

次要结局

  • dyspnea score(30 minutes per arm)

研究者

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

dr. Stefano Nava

Chief of Respiratory and Critical care Unit

IRCCS Azienda Ospedaliero-Universitaria di Bologna

研究点 (2)

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