Thora-3Di™ Respiratory Rate Validation
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 43
- 试验地点
- 4
- 主要终点
- The root mean squared difference (RMSD) in Respiratory Rate between the test (Thora-3Di) and reference Device (COSC)
研究概览
简要总结
Respiratory rate (RR) is a vital sign used to monitor clinical condition of a patient. Various devices using different techniques are available to measure RR. One technique, capnography, uses continuous monitoring of expired gases, via a nasal cannula to assess end tidal CO2 concentration. This long-established technique is frequently used for patients in intensive care. Both RR and the shape of the capnogram waveform, which has a wave pattern marked by alternating inspiratory and expiratory phases, are used to help monitor the patient. Clinician Over-scored End Tidal C02 (COSC) waveform (whereby an expert identifies and scores each breath on the waveform and counts the number of breaths per minute) is considered to be a "gold standard" for measuring RR.
Being able to record RR, without contact or interference with the patient is appealing because it requires minimal patient co-operation, enables measurements even during acute respiratory conditions, and may be more representative of "real life" physiology. Based on a principle originally described in the 1980s, a novel instrument that uses a completely non-contact system based on structured light plethysmography (SLP) has recently been designed by Cambridge University Hospitals Foundation Trust. The device has been refined with the development of the Thora-3Di by Pneumacare Ltd, Cambridge. A grid of visible light is projected onto the thoraco-abdominal wall and two digital video cameras record changes in the grid pattern due to breathing motion. A waveform is produced by the anterior excursion of the thoraco-abdominal wall (SLPVol) over time, and a numerical output of RR is provided . The present study aims to simultaneously measure tidal breathing with the Thora-3Di and a BCI Capnograph 9004 device to compare the Thora-3Di RR output against that of the gold standard clinician over-scored end-tidal C02 (COSC) and to assess equivalence of the two devices with the aim to establishing the validity of SLP for RR measurement.
详细描述
Objectives:
The primary objective is to demonstrate equivalence of the Thora-3Di™ SLP device and a Clinician Over-scored End Tidal C02 (COSC) derived from a Capnograph (BCI Capnograph 9004), Smiths Medical) for measurement of Respiratory Rate.
Endpoint:
The primary endpoint is the difference in the Respiratory Rate between the two devices.
Test Article:
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Male or female,
- •Age range 18-80 years,
- •BMI range 18-40 kg/m2
- •Patients with respiratory disease or breathing impairment (Patient Group) or normal subjects with no previous or current diagnosis of respiratory disease (Normals group)
排除标准
- •Patient unable to sit in an upright position for required period of time
- •Patients with significant co morbidities (assessed by the clinician at screening only):
- •Significant unilateral lung disease e.g. pneumonectomy
- •Chest wall or spinal deformity e.g. scoliosis
- •Obstructive Sleep Apnoea, Apnoea hypopnoea index > 30 (if known)
- •Inability to consent/comply with trial protocol
- •Presence of an acute disease process that might interfere with test performance (e.g. Nausea, vomiting, persistent coughing)
结局指标
主要结局
The root mean squared difference (RMSD) in Respiratory Rate between the test (Thora-3Di) and reference Device (COSC)
时间窗: 1 minute (randomly selected) of a 5 minute measurement period
The test device will be accepted as sufficiently accurate if the RMSD is significantly less than 0.9 brpm (significance level 0.05, power 0.8)
次要结局
未报告次要终点