None listed
Conditions
Brief summary
Overnight polysomnography (PSG) is the gold standard for diagnosing sleeprelated breathing disorders such as obstructive sleep apnoea (OSA). The monitoring of work of breathing during sleep is paramount to help differentiate between different types of sleep disordered breathing, which direct the cause and hence management for sleep disordered breathing in children. The American Academy of Sleep Medicine and the Australasian Sleep Association deems the definitive measure of work of breathing as changes in oesophageal pressure (Poes) during sleep, which is measured using a catheter (thin flexible tube) inserted into the oesophagus. Measuring the diaphragm muscle (our main breathing muscle)'s electrical activity (EMGdi) is another way of accurately assessing work of breathing during sleep. Simultaneous recording of Poes and EMGdi offers different and complementary information about the function of our diaphragm. Currently TGA approved devices in Australia can only measure Poes or EMGdi using two separate oesophageal catheters. More recently, an oesophageal ballon multipair electrode catheter designed by Yinghui Medical has been used overseas in infants and adults to measure Poes and EMGdi simultaneously using one catheter.It has been used during normal breathing awake, during sleep, and during exercise. Its size is similar to a feeding tube used in children. It is well tolerated without any significant adverse events reported. It has not being custom made for use in children previously. Our pilot study's aim is to investigate the tolerability, safety, and feasibilty of using this oesophageal balloon catheter with multipair electrodes designed by Yinghui Medical in infants and children to assess their work of breathing during sleep. All children (<18 y.o) referred by their sleep physician to Sydney Children's Hospital's Sleep Lab is eligible for this study, unless they already have nasogastric or nasojejunal tube insitu for feeding. The catheter will be inserted by the research doctor with the help of an experienced nurse and play therapist, as part of routine sleep study set up. Any adverse events associated with the catheter (safety), how many children and the number of hours the children were able to tolerate having the catheter in situ (tolerability), and whether meaningful Poes and EMGdi were able to be recorded (feasibility) will be assessed.
Interventions
Ying Hui Medical's oesophageal and gastric balloon catheter with multipair silver electrodes;The paediatric version of the catheter will consist of a polyurethane tube with 10 x 5 mm length silver plated copper coils which have a 1 mm gap between adjacent recording electrodes. The catheter would have the same diameter as a 7- French gauge nasogastric feeding tube (2.3 mm diameter). There will be two latex balloons (oesophageal and gastric balloons) mounted on the same polyurethane catheter which
Ying Hui Medical's oesophageal and gastric balloon catheter with multipair silver electrodes;The paediatric version of the catheter will consist of a polyurethane tube with 10 x 5 mm length silver plated copper coils which have a 1 mm gap between adjacent recording electrodes. The catheter would have the same diameter as a 7- French gauge nasogastric feeding tube (2.3 mm diameter). There will be two latex balloons (oesophageal and gastric balloons) mounted on the same polyurethane catheter which are both 2.5 cm in length to measure oesophageal and gastric pressure. The adult version of the catheter (which will be used in children > 12 y.o) will be the same as the catheter used in previous published research. The catheter will consist of a polyurethane tube with 10 x 10 mm length silver plated copper coils which are 1 mm apart. The diameter of the catheter will be 2.8 mm ( similar to an 8 French gauge nasogastric feeding tube). There will be two latex balloons ( oesophageal and gastric balloons) mounted on the same polyurethane catheter which are 7 cm in length. The catheter will be inserted by trial physician, with the assistance of a play therapist, an experienced paediatric nurse at the sleep lab. Routinely the sleep study commence between 1800-2100 (depending on the sleep time of the child), and ends between 0500-0600. The catheter will be removed at the end of the sleep study, similar to all the other routine sleep study set up. Each child will have the catheter in situ overnight for the entire duration of the sleep studies for one night only at SCH sleep laboratory (or until the catheter is removed for any reason). As per routine sleep study set up, the child will be observed by a sleep technician or sleep lab nurse during the entire duration of the sleep study via a camera installed in the sleep study room. Whilst the catheter is in situ, the data collected on diaphragmatic EMG, oesophageal and gastric pressure, will be recorded and visualised in real time. Minor adjustment to the catheter may be made to ensure the catheter is at the optimal position.
Sponsors
Sydney Children's Hospital Network
Study design
Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Diagnosis
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
No minimum to 18 Years
Healthy volunteers
No
Inclusion criteria
Male or female 0-18 years of age Referred by their sleep physicians for a sleep study at SCH due to suspicion of sleep disordered breathing. Parents / carers willing to give written informed consent and participate in the study.
Exclusion criteria
Patients who have a nasogastric / nasojejunal tube in-situ. Children who have a known allergy to latex. Children who is known to have achalasia, oesophageal varices or strictures, previous oesophageal atresia / tracheo-oesophageal fistula repaired, recent nasal surgery, coagulation abnormality, presence of severe facial trauma or basal skull fractures. Parents/ carers not able to give informed consent or comply with the study due to language difficulties.
Outcome results
None listed