Feasibility Study of a Non-invasive Device to Quickly, Easily and Accurately Measure Respiration in a Clinical Setting
试验速览
- 阶段
- 不适用
- 入组人数
- 150
- 试验地点
- 2
- 主要终点
- Accuracy of this device on disease subjects in a clinical setting.
研究概览
简要总结
Healthcare facilities worldwide still measure respiration manually by counting and timing chest movements. In clinical departments that are fast-paced in nature and that have either high patient volumes or require more accurate measurements (e.g. emergency and respiratory wards), manual methods of counting respiration can be slow, laborious and highly subjective. While potential solutions such as electrocardiography (ECG) and capnography (CPG) have been explored for more objective monitoring of respiration, they are not fast enough due to long setup times to get patient and system ready and prolonged periods of connection to patients. Furthermore, such ECG/CPG based solutions can be costly, are generally sufficient for patients in high dependency units, and may be impractical to deploy in a remote setting.
详细描述
The study will be divided into 2 phases - 1st phase will last 1.5 months and will aim to recruit at least 50 patients and at most 100 patients. This phase will aim to recruit near-equal split of patients across the 3 disease states of COPD, asthma and pneumonia - 35 COPD, 35 Asthma and 30 pneumonia patients. The 2nd phase will last 3 months and will aim to recruit at least 50 patients. This phase can have a mix of patients having either COPD, asthma, pneumonia, congestive heart failure or any other respiratory diseases
The aim in the 1st phase is to benchmark the device against manual counting of respiration (number of breaths per minute). The aim in the 2nd phase is to benchmark the device against existing technologies, namely lead-based-ECG sensing, acoustic sensing and capnography. This phase can have a mix of patients having either COPD, asthma, pneumonia or any other respiratory diseases
Following is the study protocol that will be implemented over the 2 phases:
Phase 1: 1.5 months - 100 patients - General Wards (Time taken for each patient is 25 mins)
a. Delegated study team members will brief the study details to the potential participants. Investigators will answer the query from potential participants if any, and complete the consent process. (5 mins) b. Trial coordinator will setup the device as follows: (10 mins) i. Disinfect the device by wiping with an alcohol swab, ii. Turn on the sensor - ensure the USB dongle is connected to the RIGHT ports on the laptop - check that the USB dongle AND the sensor light is NOT blinking iii. Paste the sensor on patient using a medical-grade adhesive tape.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 21 Years 至 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients diagnosed with cardio-respiratory diseases of either asthma, COPD, pneumonia, congestive heart failure or any other respiratory diseases.
- •Patients should be able to provide informed consent either personally or through the next-of-kin. The study will consider a mix of mild to severe cases and will not be specific to either gender, sex or ethnicity.
- •Patients with congestive heart failure only from general ward or cardiology high dependency units.
排除标准
- •Patients that are either mentally incompetent, younger than 21 years of age, prisoners, pregnant or breastfeeding women.
- •Patients with metallic/electrical implants e.g. pacemakers, cardiac devices, airway stents, neurostimulators etc.
- •Patients with coronary stents insitu are eligible for enrolment into the study. Any medical condition which makes the candidate an inappropriate subject for study participation, in the investigator's judgment will further be excluded.
- •Congestive heart failure patients on antibiotics or with infection.
- •Congestive heart failure patients beyond 72 hours of presentation from enrolment. Intent is to capture congestive heart failure at the acute stage, prior to resolving.
结局指标
主要结局
Accuracy of this device on disease subjects in a clinical setting.
时间窗: 4.5 Months
The device will be compared against "gold-standard" manual counting and against existing technologies such as lead-based ECG, capnography and acoustic-based sensing.
次要结局
未报告次要终点