NCT04240925Unknown不适用
Tolerability, Safety and Efficacy of Sigh During Non-invasive Mechanical Ventilation in Patients With Motor Neuron Disease- A Pilot Study
Ospedale San Raffaele1 个研究点 分布在 1 个国家目标入组 44 人开始时间: 2018年5月25日最近更新:
适应症
干预措施
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 44
- 试验地点
- 1
- 主要终点
- Changes in nocturnal oxygen desaturation index (ODI) assessed by transcutaneous nocturnal oximetric registration
研究概览
简要总结
Non-invasive mechanical ventilation (NIMV) is the recommended standard of care as initial therapy for patients with motor neuron disease (MND) with deterioration of the respiratory function.
SIGH_01 study is aimed at investigating the tolerability, safety profile and efficacy of sigh breaths during non-invasive mechanical ventilation in patients with MND in comparison to the standard ventilation support protocol.
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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Willing and able to give informed consent
- •MND diagnosis according to El-Escorial criteria
- •Non-invasive ventilation indications in accordance with the international guidelines
排除标准
- •Inability to adhere to study visit schedule or lack of reliable caretaker
- •Presence of dementia
- •History of arrhythmia, heart failure or pneumothorax
研究组 & 干预措施
Standard NIMV protocol with sigh breaths
Experimental
干预措施: NIMV with sigh breaths (Device)
Standard NIMV protocol without sigh breaths
Active Comparator
干预措施: Standard NIMV (Device)
结局指标
主要结局
Changes in nocturnal oxygen desaturation index (ODI) assessed by transcutaneous nocturnal oximetric registration
时间窗: Evaluation will be performed before NIMV initiation and two months after
次要结局
- Changes in the arterial blood Ph assessed by arterial blood gas test(Evaluation will be performed before NIMV initiation and two months after)
- Changes in self-perceived quality of life(QoL) assessed by 5-item Amyotrophic Lateral Sclerosis Assessment Questionnaire (ALSAQ-5). Score between 0 and 100 pts (higher score denotes worse QoL)(Evaluation will be performed before NIMV initiation and two months after)
- Changes in the arterial blood PO2 concentration assessed by arterial blood gas test(Evaluation will be performed before NIMV initiation and two months after)
- Changes in nocturnal dyspnoea assessed by Numeric Rating Scale (NRS). Score between 0 to 10, where higher scores denote a worse nocturnal dyspnoea.(Evaluation will be performed before NIMV initiation and two months after)
- Changes in the arterial blood PCo2 concentration assessed by arterial blood gas test(Evaluation will be performed before NIMV initiation and two months after)
- Changes in the forced vital capacity (FVC) assessed by spirometry test(Evaluation will be performed before NIMV initiation and two months after)
- Changes in sleep quality assessed by Pittsburg Sleep Quality Index (PSQI) questionnaire. Score between 0 to 21, where higher scores denote a worse sleep quality.(Evaluation will be performed before NIMV initiation and two months after)
- Changes in sleep quality assessed by Numeric Rating Scale (NRS). Score between 0 to 10, where higher scores denote a worse sleep quality.(Evaluation will be performed before NIMV initiation and two months after)
研究者
Nilo Riva
Principal Investigator
Ospedale San Raffaele
研究点 (1)
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