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Trial registered on ANZCTR


Registration number
ACTRN12614001254684
Ethics application status
Approved
Date submitted
20/11/2014
Date registered
2/12/2014
Date last updated
10/11/2015
Type of registration
Prospectively registered

Titles & IDs
Public title
A Pilot Study to Investigate the Feasibility, Tolerability and Safety of Using a Single Oesophageal Balloon Catheter with Multipair Electrodes to Assess Work of Breathing in Children during Sleep
Scientific title
Feasibility, Tolerability, and Safety of using Yinghui Medical's single oesophageal balloon catheter with multipair electrodes to assess respiratory effort ( as measured by transdiaphragmatic pressure and catheter measured diaphragm electromyogram) in children with suspected sleep disordered breathing during sleep studies.
Secondary ID [1] 285708 0
None
Universal Trial Number (UTN)
U1111-1164-3842
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Sleep disordered breathing 293578 0
Condition category
Condition code
Respiratory 293861 293861 0 0
Sleep apnoea

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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.
Intervention code [1] 290656 0
Diagnosis / Prognosis
Comparator / control treatment
No comparator intervention.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 293643 0
1. For the outcome of safety, the data collected will be the same for participants across different age groups, including vital signs (heart rate, respiratory rate, oxygen saturation level), hoarse voice or cry, cough, sore throat (if able to express in words), nose bleed or vomit from the insertion process, pain (described by child or perceived by carer), persistent bradycardia due to presence of the catheter, complications associated with the catheter itself including rupture of the balloon whilst in-situ.
The occurrence of any adverse outcome will be documented by sleep technician / sleep nurse at the time it arise or during routine observation time throughout the sleep study.
Timepoint [1] 293643 0
Duration of sleep study or until the catheter is removed.
Primary outcome [2] 293691 0
2. For the outcome of tolerability, the data collected will be the same for participants across different age groups – success or failure of insertion of oesophageal catheter, the number of participants (or carers) who requested the catheter to be removed, the length of time the participant tolerated the catheter in-situ before its removal (< 30 minutes, < 1 hour, < 3 hours, <8 hours).
A visual scale (and an additional 100mm visual analogue scale for children > 12 y.o) will be used to assess pain and discomfort associated with the catheter insertion process.
Timepoint [2] 293691 0
Duration of sleep study or until the catheter is removed.
Primary outcome [3] 293692 0
3. For the outcome of feasibility, the data collected will be same for participants across different age groups – namely the EMGdi and Poes / Pgas recorded which will be analysed offline.
Timepoint [3] 293692 0
Duration of sleep study or until the catheter is removed.
Secondary outcome [1] 311512 0
No secondary outcome.
Timepoint [1] 311512 0
No secondary timepoint.

Eligibility
Key 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.
Minimum age
No limit
Maximum age
18 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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.

Study design
Purpose of the study
Diagnosis
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
All children who are referred for sleep study at the Sleep Lab at SCH are given written information on the study by their sleep physician on the day of sleep clinic review. Interested families are then approached in person by the research team on the same day. A tour of the sleep lab with all the routine sleep study set up placed in a tray (including the oesophageal catheter) will be shown to the child and the parent. The child is encouraged to touch and handle the electrodes, wires, sensors, and oesophageal catheters.
On the day of the planned sleep study, written consent will be obtained from the parents / carers by the principal researcher who will insert the catheter.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
No randomisation.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis
All variables which are normally distributed will be expressed as mean +/- SD. Data not normally distributed are presented as median (25th-75th quartile) and assessed using the Mann-Whitney U test. Up to date version of SAS (Cary, NC) and SPSS (Chicago, IL) will be used to conduct analyses. A two sided p value <0.05 will be deemed as being statistically significant.
The collected data from all participants will be included in the result analysis even if the catheter was withdrawn prior to the end of the sleep study.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/02/2016
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
30
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 3176 0
Sydney Children's Hospital - Randwick
Recruitment postcode(s) [1] 8966 0
2031 - Randwick

Funding & Sponsors
Funding source category [1] 290281 0
Hospital
Name [1] 290281 0
Sydney Children's Hospital
Respiratory Department
Country [1] 290281 0
Australia
Primary sponsor type
Hospital
Name
Sydney Children's Hospital Network
Address
Corner Hawkesbury Road and Hainsworth Street
Westmead NSW 2145
Country
Australia
Secondary sponsor category [1] 288993 0
None
Name [1] 288993 0
Address [1] 288993 0
Country [1] 288993 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 291982 0
Sydney Children's Hospital Network Human Research Ethics Committee
Ethics committee address [1] 291982 0
Corner Hawkesbury Road and Hainsworth Street
Westmead NSW 2145
Ethics committee country [1] 291982 0
Australia
Date submitted for ethics approval [1] 291982 0
22/01/2014
Approval date [1] 291982 0
02/06/2014
Ethics approval number [1] 291982 0
HREC/14/SCHN/12

Summary
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.
Trial website
Trial related presentations / publications
Public notes
Attachments [1] 248 248 0 0
/AnzctrAttachments/367472-HREC.14.SCHN.12 - Ethics Approval - 2 June 2014.pdf

Contacts
Principal investigator
Name 52946 0
Dr Sandra Chuang
Address 52946 0
School of Women's and Children's Health
Sydney Children's Hospital
High Street
Randwick NSW 2031
Country 52946 0
Australia
Phone 52946 0
+61293821111
Fax 52946 0
Email 52946 0
[email protected]
Contact person for public queries
Name 52947 0
Sandra Chuang
Address 52947 0
School of Women's and Children's Health
Sydney Children's Hospital
High Street
Randwick NSW 2031
Country 52947 0
Australia
Phone 52947 0
+61293821111
Fax 52947 0
Email 52947 0
[email protected]
Contact person for scientific queries
Name 52948 0
Sandra Chuang
Address 52948 0
School of Women's and Children's Health
Sydney Children's Hospital
High Street
Randwick NSW 2031
Country 52948 0
Australia
Phone 52948 0
+61293821111
Fax 52948 0
Email 52948 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

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