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临床试验/NCT01499550
NCT01499550已完成不适用

Nocturnal Transnasal Insufflation in Patients With COPD and Hypercapnia

Institut für Pneumologie Hagen Ambrock eV2 个研究点 分布在 1 个国家目标入组 31 人开始时间: 2011年8月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
31
试验地点
2
主要终点
PCO2 decrease

研究概览

简要总结

On the basis of different studies the long term oxygen treatment is deemed to be routine treatment in patients suffering from chronic obstructive pulmonary disease (COPD) at appearance of hypoxaemia. Non invasive ventilation (NIV) is the treatment of choice in hypercapnic COPD patients with respiratory acidosis at acute respiratory decompensation. Several prospective randomized studies have shown a reduction of acute mortality as result. But everyday practice shows that COPD patients with chronic hypercapnia hardly accustom oneself to nocturnal ventilation. Reasons are not known yet, but substantial pulmonary overinflation or the appearance of depressions or rather anxiety disorders are possible causes. On the other hand patients may not notice any subjective improvement of symptoms and won't accept the burden of a tight fitting mask during the night. The aim of the present study is to determine the effect on gas exchange of a nocturnal transnasal application of an oxygen-enriched gaseous mixture via nasal cannula and the subjective acceptance. This is compared to a nocturnal transnasal application of oxygen alone in randomized order for at least 6 hours each night.

Thirty hypercapnic COPD GOLD IV patients (PCO2 > 50 mmHg) will be included. The two night Polysomnographies (PSG) will be evaluated with special attention to nasal flow measurements, breathing effort, oxygen saturation and an additional transcutaneous PCO2 measurement. At begin and end of each measurement night a capillary blood gas analysis is made.

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
20 Years 至 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Hypercapnia in Routine Blood Gas Analysis with > 50 mmHg PCO2
  • Clinically stable respiratory situation
  • Treatment on normal ward possible

排除标准

  • Before known obstructive sleep apnea syndrome (OSA)
  • A found OSA during study means no exclusion
  • Any other severe or acute physical illness which requires intensive medical care
  • Acute hypercapnic decompensation with pH < 7.30 in capillary Blood Gas Analysis

结局指标

主要结局

PCO2 decrease

时间窗: within 2 days

During the study nights the patients PCO2 value is measured transcutaneous as well as by capillary blood gas analyses (BGA) in the evening and in the morning. The differences in PCO2 values of the morning BGA will be compared, a PCO2 decrease is supposed to be assessed under TNI treatment.

次要结局

  • Changes of breathing pattern(within 2 days)

研究者

发起方
Institut für Pneumologie Hagen Ambrock eV
申办方类型
Industry
责任方
Principal Investigator
主要研究者

Georg Nilius

Head of the Department of pneumology at Helios Klinik Ambrock

Institut für Pneumologie Hagen Ambrock eV

研究点 (2)

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