Randomized Trial Comparing Telemedicine Monitoring and Titration in Patients Initiating Non-invasive Ventilation With Usual Care (TELEMOTINIV Study)
试验速览
- 阶段
- 1 期
- 入组人数
- 128
- 试验地点
- 2
- 主要终点
- Nocturnal noninvasive ventilation compliance per day
研究概览
简要总结
The critical nature of respiratory diseases, the continuously increasing prevalence of these conditions, and the subjective perception of patients vis-à-vis their pulmonary function and health status underscore the importance of home telemonitoring. These conditions are critical and necessitate close and regular monitoring that may be achieved at distance using telemonitoring. This study will assess a number of measures both at baseline and post-intervention from a number of domains, including Arterial Blood Gases (ABG), BiPAP-related data, chronic respiratory failure symptoms, health-related quality of life, patients satisfaction and utilization of healthcare resources.
详细描述
In recent years home care is becoming increasingly used and considered by some the future of healthcare. Home mechanical ventilation has been shown to improve morbidity and mortality in patients with chronic respiratory failure of different aetiologies. A French survey suggests an increase of 12% of cases per year. With the prospect of a substantial increase of ventilated patients at home, facilities and resources have not been proportionally growing, so new approaches should be investigated and addressed to absorb this constant flux of patients.
Telemedicine is defined as the broad use of electronic and communications technologies to provide and support remote monitoring of health status. It has been shown to be an effective alternative model of care for managing chronic diseases. It as also been shown to reduce healthcare costs and is a major topic on the agendas of health and social care policies in Europe.
Home telemonitoring of respiratory conditions results in early identification of deteriorations in patient condition and symptom control.
However, evidence on the magnitude of clinical and structural effects remains preliminary, with variations in study approaches and an absence of robust study designs and formal evaluations.
The objective is gathering data that can be help to establish guidelines for non invasive home mechanical ventilation initiation and quality control.
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
- Double (Participant, Care Provider)
入排标准
- 年龄范围
- 15 Years 至 80 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •PaCO2 > 45 mmHg;
- •IMC > 40 Kg/m2
- •Age < 80 years;
- •Receiving appropriate medical therapy according to gold guidelines
- •Long-term oxygen therapy (LTOT) for at least 3 months;
- •PaCO2 > 50 mmHg during room air
- •ph > 7,35 and free from exacerbations in the 4 weeks preceding recruitment;
- •One exacerbation in the last year before preceding recruitment with necessity of NIV in the acute care setting;
- •FEV1 < 1,5l or < 50% predicted;
- •FEV1/FVC < 60%
- •Total Lung Capacity (TLC)≥ 90% predicted;
- •PaO2 < 60 mmHg breathing room air at rest.
- •NMD and CWD:
- •PaCO2 > 45 mmHg;
- •Significant nocturnal desaturation
- •FVC < 50% predicted;
- •SNIP < 40 cmH20
- •MIP < 60% predicted
- •Ortopnea;
- •20% drop of VC in supine position.
排除标准
- •15% increase in FEV1 after inhaled Salbutamol (200 µg);
- •Active smoking;
- •History of OSA (with AHI > 15 episodes.h-1)
- •NMD and CWD:
- •PCF < 270;
- •Severe bulbar weakness (ALSFRS bulbar subscore 0-3)
结局指标
主要结局
Nocturnal noninvasive ventilation compliance per day
时间窗: 9 months
We aim to detect a difference of 1 hour in the mean of nightly hours of use, assuming a standard deviation (SD) of 2 hours.
次要结局
- Health Economics Evaluation(9 months)
- Health related Quality of Life(9 months)
- Arterial Blood Gases(9 months)
研究者
Miguel R. Goncalves
Clinical Professor
Hospital Sao Joao