Telemonitoring Utility in the Process of Adaptation to Home Mechanical Ventilation
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 48
- 试验地点
- 2
- 主要终点
- Measurement of pCO2 by arterial blood gas
研究概览
简要总结
The goal of this clinical trial is to evaluate whether telemonitoring, added to the usual process of adaptation to home mechanical ventilation (HMV), achieves a more efficient correction of hypoventilation (reduction of hypercapnia).
详细描述
The study population consist of patients with hypercapnic respiratory failure eligible for Home Mechanical Ventilation (HMV) with a total of 48 subjects (24 per group).
In those patients with hypercapnic respiratory failure who have an indication for home mechanical ventilation (HMV), without criteria for life support, the initial titration will be performed following the protocol of the Pulmonology Service. After their education, patients will be randomized into one of the following groups: the control group and the telemonitoring group with daily review of Home Mechanical Ventilation (HMV) data. The objectives are to evaluate whether hypoventilation is corrected more efficiently, compare treatment adherence between both groups, analyze unforeseen visits, and assess the number of hospital admissions.
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
- 否
入选标准
- •Chronic hypercapnic respiratory failure with indication for home mechanical ventilation.
- •Patients who require ventilation with spontaneous-timed mode.
- •Signing of informed consent.
排除标准
- •Patient already treated with mechanical ventilation or home CPAP.
- •Patient requiring mechanical ventilation as life support.
- •Pregnancy.
- •Cognitive impairment that makes it impossible to understand the informed consent for the study.
- •Psychiatric pathology that makes compliance with therapy or its follow-up difficult.
- •Impossibility of complying with the protocol.
- •Expected survival less than 12 months.
- •Any other condition that, in the opinion of the researcher, could interfere with the objectives of the study
结局指标
主要结局
Measurement of pCO2 by arterial blood gas
时间窗: 6 months
The partial pressure of carbon dioxide (PCO2) is the measure of carbon dioxide within arterial or venous blood. The moment (day) in which normal pCO2 is detected (pCO2 \< 45 mmHg) will be determined as the success of the therapy.
次要结局
- Adherence(6 months)
- Unforeseen visits(6 months)
- Hospital admissions(6 months)