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A Study to Investigate the Effects of Heated Humidification During Non-Invasive Ventilation

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ClinicalTrials.gov Identifier: NCT01372072
Recruitment Status: Completed
第一次发布：2011年6月13日
Last Update Posted: October 8, 2021
Sponsor:
Information provided by (Responsible Party):
盖伊和圣托马斯的NHS基金会信任

Study Description
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Brief Summary:
非侵入性通气（NIV）是掩模递送的通风形式，是急性和慢性呼吸道（呼吸）失效患者的重要治疗方式。加湿被广泛被认为是接受侵入式通气患者通风策略的重要组成部分（即通过插入口管的管），但它在NIV使用期间的作用是不证明的。因此，在NIV期间的加湿方面存在实践的变化。加湿在维持上下气道粘膜功能和需要NIV的患者由于缺乏气道湿度而导致需要NIV的患者，例如报告喉咙干燥。NIV在急性环境中的成功依赖于许多因素，包括在急性期内患有患者的耐受性。在患有慢性阻塞性气道疾病（COPD）的患者中，耐受性差的耐受性导致NIV衰竭，这需要气管内插管或治疗失败。此外，侵入性通风会增加医院获得的肺炎的风险，这与更糟糕的结果有关。在NIV使用的长期设置中，患者常常报告由于呼吸道的干燥而症状，并粘附到NIV可能是高度可变的。这些患者的依从性在提高生活质量和长度方面都很重要。加湿装置可能在技术上有效，但临床医生有关于这些设备的潜在负面影响的担忧。 There is a requirement to evaluate the use of humidification in both the acute and long term use of NIV, particular, in terms of patient ventilator interaction, which will impact on comfort and adherence to NIV. This will effect the overall effectiveness of ventilation. The investigators propose a randomised controlled trial to investigate the effects of a humidification system during noninvasive ventilation.

病情或疾病 Intervention/treatment 阶段
Chronic Obstructive Pulmonary Disease慢性呼吸高原衰竭Neuromuscular DiseaseObesity Hypoventilation Syndrome 设备:non-invasive ventilation heated humidification (Fisher-Paykel MR810 and MR850 humidifiers) 不适用

Study Design
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学习信息的布局表
Study Type: 介入(临床试验)
ActualEnrollment: 15 participants
Allocation: Randomized
干预模型： Crossover Assignment
掩蔽： 没有（开放标签）
Primary Purpose: 治疗
Official Title: A Pilot Study to Investigate the Physiological and Clinical Effects of Heated Humidification During Non-Invasive Ventilation
ActualStudy Start Date: February 1, 2012
ActualPrimary Completion Date: September 30, 2014
ActualStudy Completion Date: September 30, 2014
Arms and Interventions
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Arm Intervention/treatment
Active Comparator: Humidification
Patients in this arm of the trial will receive humidification with the non-invasive ventilation.
 设备:non-invasive ventilation heated humidification (Fisher-Paykel MR810 and MR850 humidifiers)
Heated humidification (Fisher-Paykel MR810 and MR850 humidifiers)
不Intervention: NIV without humidifivation
As per usual practice patients in this arm will not have humidification with their NIV


Outcome Measures
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Primary Outcome Measures:
  1. Adherence to NIV [ Time Frame: up to 8 weeks ]

Eligibility Criteria
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来自国家医学图书馆的信息

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Ages Eligible for Study: 18岁至100年（成人，老年人）
Sexes Eligible for Study: All
接受健康的志愿者： 不
Criteria

Inclusion Criteria:

  • hypercapnic respiratory failure
  • age > 18
  • requiring non-invasive ventilation

Exclusion Criteria:

  • psychiatric illness
  • pregnancy
联系人和地点
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来自国家医学图书馆的信息

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number):NCT01372072


Locations
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United Kingdom
St Thomas' Hospital
London, United Kingdom
赞助和合作者
盖伊和圣托马斯的NHS基金会信任
Investigators
调查员信息的布局表
Principal Investigator: Swapna Mandal 盖伊和圣托马斯的NHS信任
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: 盖伊和圣托马斯的NHS基金会信任
ClinicalTrials.gov Identifier: NCT01372072
Other Study ID Numbers: RJ1 11 / N141
第一次发布: June 13, 2011Key Record Dates
Last Update Posted: October 8, 2021
Last Verified: September 2021
由Guy's And Thomas的NHS基金会信任提供的关键字：
慢性呼吸高原衰竭
Additional relevant MeSH terms:
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Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Hypoventilation
Obesity Hypoventilation Syndrome
Neuromuscular Diseases
Hypercapnia
Lung Diseases
呼吸道疾病
Nervous System Diseases
Signs and Symptoms, Respiratory
呼吸不足
 呼吸紊乱
Sleep Apnea, Obstructive
Sleep Apnea Syndromes
Apnea
睡眠障碍，内在
Dyssomnias
Sleep Wake Disorders
Obesity
Overnutrition
Nutrition Disorders