The PARS Study: Paediatric Advanced Respiratory Service Study - An Observational Diagnostic Feasibility Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 225
- 试验地点
- 3
- 主要终点
- Assess the feasibility of collecting respiratory waveform data using Pneumowave device in patients who have (1) attended the sleep laboratory for CR- polysomnography and (2) are inpatient in neonatal unit
研究概览
简要总结
Diagnostic investigations in paediatric respiratory and sleep medicine are often challenging due to patient size (due to prematurity), tolerability, and compliance with "gold standard equipment". Children with sensory/behavioural issues, at increased risk of sleep disordered breathing (SDB), often find tolerating standard diagnostic equipment difficult. There is a need to develop non-invasive, wireless, devices designed for the paediatric population. Devices must address health in-equalities as high-risk children, with low birth weights, genetic syndromes, or complex neuro-disabilities, are often unable to undergo current investigations, particularly in sleep medicine. Prompt and accurate diagnosis of SDB is important to facilitate early intervention and improve outcomes
Infants in the neonatal period can have immature breathing control which manifests as excessive central breathing pauses, apnoea's, whilst asleep requiring oxygen therapy. There is also a risk to newborn term infants of sudden unexpected neonatal collapse, even in "low risk" babies. Diagnosis of breathing issues in babies can be challenging since babies are often too small for standard monitoring equipment. Effective monitoring and appropriate treatment of apnoea's has been shown to improve prognosis in terms of 5-year mortality and neurodevelopmental outcomes.
Children with epilepsy are at risk of epileptic apnoea during a seizure (ictal) or post-ictal apnoea following an epileptic seizure. Epileptic and post-ictal apnoea have been implicated as causes of sudden unexpected death in epilepsy (SUDEP). Epilepsy affects approx. 50 million people worldwide. The risk of SUDEP varies in different underlying causes of epilepsy but is estimated to be the cause of 1.2 deaths for every 1,000 children with epilepsy each year.
This observational study is part of a phased clinical program of research that aims to validate a small wearable biosensor developed by PneumoWave Ltd in a paediatric clinical setting with the overall primary endpoints of monitoring and assessing respiratory pattern as an aid to sleep diagnostics, and as a device to monitor apnoea in neonatal patients and children with epilepsy at risk of SUDEP.
详细描述
Sleep diagnostics
The investigation of sleep disordered breathing (SDB) in children can be challenging given the requirement to apply sensors/bands that measure physiological changes as part of a cardiorespiratory sleep study (CR-poly). Children with sensory/behavioural issues, who have an increased risk of SDB, often find tolerability of standard diagnostic equipment difficult. Similarly, the usefulness is limited in low weight infants. Thus, there is a need to investigate novel devices which may provide sleep diagnostic information when a CR-poly may be inappropriate or challenging. A wearable respiratory rate (RR)/effort sensor can provide continuous remote monitoring of patients and may identify abnormal breathing patterns associated with SDB.
Central apnoea and abnormal breathing patterns in neonatal patients
Babies born prematurely can often have apnoea of prematurity requiring caffeine therapy. Similarly, term (or term corrected) infants can have immature breathing control which manifests as excessive central breathing pauses whilst asleep requiring oxygen therapy. There is also a risk to newborn term infants of sudden unexpected collapse, even in "low risk" babies. Diagnosis of breathing issues in babies can be challenging since babies are often too small for standard CR-poly equipment. We aim to use the Pneumowave sensor alongside other diagnostic equipment to assess the feasibility of using this novel sensor to aid diagnosis in the post-natal period and pre-discharge from neonatal unit. Currently, newborn infants receive no standard respiratory monitoring following delivery. We aim to use the Pneumowave sensor as an indicator of altered respiratory patterns in this patient group.
Apnoeas in patients attending the epilepsy monitoring unit
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
- 1 Minute 至 16 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Group 1 - CR-poly group
- •Patient undergoing overnight CR-poly
- •Age birth to >=16 years
- •Are willing and able to give informed assent/consent or have available next of Kin to provide informed consent on the participant's behalf
- •Able (in the Investigators opinion) to comply with all study requirements
- •Can speak and read English
- •Group 2 - Apnoea group
- •Inpatient in neonatal unit
- •Age birth (from 30 weeks gestational age) to term corrected
- •Parents willing and able to give informed consent
- •Able (in the Investigators opinion) to comply with all study requirements
- •Can speak and read English
- •Group 3- VT Group attending epilepsy monitoirng unit
- •Inpatient receiving video-telemetry epilepsy monitoring unit
- •Age birth to <16 years
- •Parents willing and able to give informed consent
- •Able (in the Investigators opinion) and willing to comply with all study requirements
- •Can speak and read English
排除标准
- •Group 1 - CR-poly group
- •Unable to provide consent and no next of kin to provide consent on participants behalf
- •Treating clinician deems patient inappropriate to be included in study
- •Group 2 - Apnoea group
- •No next of kin to provide consent on participants behalf
- •Treating clinician deems patient inappropriate to be included in study
- •Group 3- VT Group attending epilepsy monitoirng unit
- •Unable to provide consent and no next of kin to provide consent on participants behalf
- •Treating clinician deems patient inappropriate to be included in study
研究组 & 干预措施
Patient attending for overnight cardiorespiratory polysomnography sleep study
Any patient attending the Royal Hospital for Children, Glasgow sleep laboratory for overnight cardiorespiratory polysomnography for evaluation of sleep disordered breathing. Pneumowave device will collect data from patients alongside standard clinical monitoring.
干预措施: Pneumowave (Device)
Patients in the neonatal unit, Royal Hospital for Children, Glasgow, at risk of central apnoea
Any patient currently in the Queen Elizabeth University Hospital campus neonatal unit at risk of central apnoea receiving standard care (this may include mechanically ventilated patients). Pneumowave device will collect data from patients alongside standard clinical monitoring.
干预措施: Pneumowave (Device)
Patients attending the epilepsy monitoirng unit for Video Telemetry
Any patient attending the Royal Hospital for Children, Glasgow Epilepsy Monitoring Unit for inpatient video-telemetry at risk of apnoea during and following seizures
干预措施: Pneumowave (Device)
结局指标
主要结局
Assess the feasibility of collecting respiratory waveform data using Pneumowave device in patients who have (1) attended the sleep laboratory for CR- polysomnography and (2) are inpatient in neonatal unit
时间窗: 2 years
1\) Length of time device in situ on patient 2) Number of times device removed by patient / other 3) Ability of device to collect data while in situ
次要结局
- Collate respiratory data in patients who have attended the sleep laboratory for CR- poly or inpatient in neonatal unit. Respiratory data will observe: (1) Normal respiratory effort (2) Response to treatments(2 years)
- Collate waveform and motion artefact data in patients who have attended overnight CR-polysomnography(2 years)
- Assess the useability of Pneumowave in the opinion of the clinician, nurse and patient(2 years)
- Collate waveform and motion artefact data in neonatal patients at risk of central apnoea(2 years)
研究者
Ross Langley
Dr Ross Langley
NHS Greater Clyde and Glasgow