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临床试验/NCT02444806
NCT02444806已完成2 期

The Clinical Effectiveness of PSG Versus Limited Respiratory Polygraphy During NIV Set up in COPD-OSA Overlap Syndrome: A Randomised Controlled Trial

Guy's and St Thomas' NHS Foundation Trust0 个研究点目标入组 14 人开始时间: 2015年1月最近更新:
适应症

试验速览

阶段
2 期
状态
已完成
入组人数
14
主要终点
PaCO2 (Arterial blood gas analysis)

研究概览

简要总结

The study aims to compare 2 different strategies used to setup non-invasive ventilation in patients with OCPD-OSA overlap.

详细描述

With limited comparative data to support the different strategies, there is substantial variation across Europe and the United States in the methods used by clinicians to set up home non-invasive ventilation (NIV) for patients with chronic respiratory failure as a consequence of sleep disordered breathing. Indeed with few data to support the practice, many centres employ full montage polysomnography, which is not only a significant physical burden to the patient but also a financial burden to the healthcare provider in terms of the facilities required, staff training and equipment.

The investigators propose to undertake a randomised controlled trial to compare the clinical effectiveness, in terms of the change in daytime arterial partial pressure of carbon dioxide (PaCO2) at 3 months, of limited respiratory polygraphy and full polysomnography to set up NIV in patients with COPD-OSA overlap. Secondary outcome measures at 3 months will include overnight control of gas exchange, subjective sleep quality, health related quality of life and ventilator adherence. COPD-OSA overlap are a patient group that have a rising prevalence with limited data currently available detailing NIV set up, which wholly supports the rationale of using this increasingly important group as a target population for this trial.

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
None

入排标准

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

入选标准

  • COPD (as defined by GOLD criteria[4])
  • OSA (ODI > 7.5 events/hr, AHI > 5events/hr)
  • PaCO2 > 6 kPa
  • BMI > 30 kg/m2

排除标准

  • Decompensated respiratory failure (pH < 7.35)
  • Inability to tolerate NIV (< 4 hours usage at in hospital titration)
  • Contraindication to NIV
  • Pregnancy
  • Aged <18
  • Significant physical or psychiatric co-morbidity that would prevent compliance with trial protocol

结局指标

主要结局

PaCO2 (Arterial blood gas analysis)

时间窗: 3 months

Arterial blood gas analysis

次要结局

  • Health related quality of life (CAT, SRI)(3 months)
  • Objective sleep comfort (Actigraphy)(3 months)
  • Spirometry (FEV1, FVC)(3 months)
  • Subjective sleep comfort (VAS)(3 months)
  • NIV compliance (machine recorded)(3 months)
  • Respiratory mechanics (to include, work of breathing, PEEPdyn, Cdyn, EMGdi, EMGpara)(Day 1)

研究者

申办方类型
Other
责任方
Sponsor

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