High Resolution Thermal Imaging Developments for Non-Contact Airflow Measurement: A Novel Child-friendly Method to Monitor Paediatric Airflow.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Comparing accuracy of the nasal sensors vs Thermal Imaging camera. Data downloaded on a software system
研究概览
简要总结
ThermPaed is a Sheffield Children's Hospital research collaborative which investigated the clinical diagnostic capabilities of high resolution thermal imaging (HRTI) in paediatrics. This research utilises thermal imaging techniques to detect fractures, arthritic inflammation and infection. ThermPaed proved HRTI has potential in paediatrics and resulted in development of techniques that has led to the current research study. The purpose of this study is to develop HRTI as a non-contact child-friendly means of measuring and monitoring paediatric airflow.
Sheffield Children's Hospital Sleep Unit performs 500 sleep studies a year to investigate paediatric sleep-related breathing disorders. 1-6% of children have problems with their breathing during sleep and have breathing pauses called apnoeas. The condition needs accurate diagnosis and treatment to ensure correct blood oxygen levels. During a sleep study a number of physiological parameters are measured. These include heart rate, chest movements, airflow, oxygen levels, body position, snoring, movement and video. A total of 13 sensors are attached to the child whilst awake, and then the child settles to sleep. Airflow parameters are measured by two contact sensors; one measures airflow by temperature and the other measures airflow by pressure. Both sensors are placed in or very close to the nostrils to detect and classify apnoea. Due to their contact nature, these sensors are poorly tolerated. In a recent survey of 100 sleep studies on the sleep unit, 50% children did not allow the sensors to be attached or removed them immediately causing difficulties in interpreting their condition.
Breathing generates changes in temperature around nose and mouth which can be detected with HRTI. The investigators will recruit 30 children who are undergoing a sleep study. The investigators will compare airflow measurements from the existing clinical nasal sensors and HRTI to evaluate whether this new technique will provide an accurate non-contact alternative to measure respiration airflow.
详细描述
The study will form part of a wider project currently ongoing which is looking into development of HRTI for clinical diagnosis and monitoring. It builds on the significant progress the investigators made through the ThermPaed study. Sheffield Hallam University supports this study by allocating an MPhil student (UR). The student will be jointly supervised at the University by Professor Saatchi who is well-established in digital signal and image processing and Professor Elphick and Dr Kingshott.
This study design is explained below. Measurement of thermal imaging alongside standard clinical parameters Following ethics and HRA approval, the investigators will identify 30 suitable children attending Sheffield Children's Hospital Sleep Unit who are undergoing cardiorespiratory PSG investigation for sleep-related breathing disorders.
Each patient would undergo the standard diagnostic cardiorespiratory PSG and wear all the sensors as usual. In addition, following consent, HRTI will be performed in the Sleep Unit overnight. The HRTI device will be positioned alongside the standard video camera used in PSG. The standard recording time of a PSG study is between 8-12 hours and is determined by the child and their age-related sleep and wake times. Even if the child does not tolerate the nasal sensors, the investigators will record HRTI to identify potentially missed apnoea events. The study therefore does not interfere in any way with the patient's normal procedures.
Patient, carer and staff opinions of the HRTI versus conventional nasal sensors.
As part of the research, the participating children, their attending carer and overnight sleep nursing staff will complete an evaluation questionnaire [Appendix 1] in the morning following the PSG.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 0 Years 至 15 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Children age 0-15.9 years Are attending the sleep unit for a cardiorespiratory sleep study to investigate or monitor sleep-disordered breathing
排除标准
- •Families who do not understand written or verbal English where no interpreter is present
- •Children who do not attend with their parent / legal guardian and so are therefore unable to give informed consent
- •Children who are undergoing tracheostomy or ventilation sleep studies and so will not be expected to wear nasal airflow sensors during their sleep study
结局指标
主要结局
Comparing accuracy of the nasal sensors vs Thermal Imaging camera. Data downloaded on a software system
时间窗: 10 months
Agreement between the apnoeas measured by HRTI and the apnoeas measured by nasal sensors.
次要结局
- How Successful is Thermal Imaging overnight. Data downloaded on a software system(10 months)
- How successful are nasal sensors in an overnight study. Data downloaded on a software system(10 months)