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Trial registered on ANZCTR


Registration number
ACTRN12617001379303
Ethics application status
Approved
Date submitted
15/09/2017
Date registered
28/09/2017
Date last updated
29/08/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
To explore oxygen saturation and sleep quality measurements in children undergoing tonsillectomy surgery.
Scientific title
Enhancing Management of Perioperative High risk paediatric tonsillectomy patients through Assessment of oxygen Saturation and Sleep quality (EMPHASIS)
Secondary ID [1] 292808 0
None
Universal Trial Number (UTN)
None
Trial acronym
EMPHASIS
Linked study record
None

Health condition
Health condition(s) or problem(s) studied:
Anaesthesiology 304624 0
Ear, Nose and Throat Surgery
304625 0
Respiratory 304626 0
Condition category
Condition code
Anaesthesiology 303943 303943 0 0
Anaesthetics
Surgery 303944 303944 0 0
Other surgery
Respiratory 303945 303945 0 0
Sleep apnoea

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
1.. ActiCal activity monitoring devices (Philips Respironics) 2 are worn by participants on the wrist and hip for 4 consecutive days up to 8 weeks prior to surgery. On the day of surgery, immediately after the surgery, the patients will be fitted with the same monitors again, which they are asked to wear for 10 to 14 days (including nights).

2. Nonin WristOx oxygen saturation device. (Nonin WristOx2, NOX medical)will be worn for 4 consecutive nights up to 8 weeks prior to surgery. On the day of surgery, immediately after the surgery, the patients will be fitted with the same monitors again, which they are asked to wear for 10 to 14 nights.

All participants will wear both devices during the same time period.
Intervention code [1] 299053 0
Diagnosis / Prognosis
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 303395 0
To explore nocturnal oximetry (number and extent of desaturations) using the Nonin WristOx oxygen saturation device pre and post tonsillectomy
Timepoint [1] 303395 0
4 nights of nocturnal oximetry in the 8 weeks prior to surgery compared to 10 to 14 nights
in the 2 weeks post surgery.
Primary outcome [2] 303396 0
To explore how sleep quality measured using the ActiCal activity monitoring devices and WristOx device change within the first 2 weeks following tonsillectomy.

Variables regarding sleeping patterns, sedentary behaviour and physical activity will be derived from the accelerometer count data using a customised LabView V7® (National Instruments, Austin, TX, USA) program. Indicators of sleep quality and quantity from the ActiCal will be derived using adaptations of validated methods. Daily minutes in each intensity level using validated age cut points for hip (sedentary <45, light >44, moderate >2028, vigorous >2872 counts per minute) and wrist worn devices (sedentary <209, light >208, moderate >1552, vigorous >4844 counts per minute) will be determined.
Timepoint [2] 303396 0
From day of surgery for 2 weeks.
Primary outcome [3] 303450 0
To explore how physical activity measured using the ActiCal activity monitoring devices change within the first 2 weeks following tonsillectomy.

Variables regarding sleeping patterns, sedentary behaviour and physical activity will be derived from the accelerometer count data using a customised LabView V7® (National Instruments, Austin, TX, USA) program. Daily minutes in each intensity level using validated age cut points for hip (sedentary <45, light >44, moderate >2028, vigorous >2872 counts per minute) and wrist worn devices (sedentary <209, light >208, moderate >1552, vigorous >4844 counts per minute) will be determined.
Timepoint [3] 303450 0
From day of surgery for 2 weeks.
Secondary outcome [1] 338830 0
To assess if preoperative nocturnal oximetry which is assessed by the Nonin WristOx can predict perioperative respiratory adverse events (PRAE) occurrence in tonsillectomy patients.
The PRAE we will be assessing include bronchospasm, laryngospasm, coughing, airway obstruction, oxygen desaturations (less than 95%) and stridor. PRAE will be assessed by the treating anaesthetist during anaesthesia or by the recovery nurse in the recovery area.
Timepoint [1] 338830 0
4 nights of nocturnal oximetry in the 8 weeks prior to surgery compared to day of surgery events (if any)
Secondary outcome [2] 338831 0
To assess capacity of pre-operative sleep-wake pattern assessed by ActiCal activity monitoring devices to predict perioperative respiratory adverse events (PRAE) in tonsillectomy patients.
The PRAE we will be assessing include bronchospasm, laryngospasm, coughing, airway obstruction, oxygen desaturations (less than 95%) and stridor. PRAE will be assessed by the treating anaesthetist during anaesthesia or by the recovery nurse in the recovery area.
Timepoint [2] 338831 0
4 days and nights in the 8 weeks prior to surgery compared to day of surgery events (if any)

Eligibility
Key inclusion criteria
Male or female, aged 3 to 10 years of age
Undergoing elective surgery under general anaesthetic for tonsillectomy (+/- adenoids, myringotomy, insertion of grommets and/or cautery of inferior turbinates surgery)
Minimum age
3 Years
Maximum age
10 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Inability to give informed consent
Children with known significant cardiopulmonary disease
Significant medical disease or condition that is likely to interfere with the protocol or might be confounded by the protocol.

Study design
Purpose
Natural history
Duration
Cross-sectional
Selection
Defined population
Timing
Prospective
Statistical methods / analysis
This study is an exploratory pilot study in a completely novel field using an entirely non-invasive approach of testing. There is currently no data in the literature with regards to oximetry and activity monitors and their correlation to the severity of perioperative respiratory adverse events (PRAE) in the paediatric population. Therefore, based on our previous work assessing the incidence of PRAE in children undergoing tonsillectomies, we estimate that a sample size of 60 children with complete data sets will allow us to assess our primary aim. Children with incomplete data sets will be replaced.
All data will be reported according to the STARD 2015 guidelines.
Thus, we believe n=60 will provide us with sufficient information on the comparison of these two variables for an appropriate and more refined sample size calculation for future research on this topic.
The Actical data will be analysed using proprietary software for a standard set of activity and sleep-based measurements. Sleep-based measurements will include sleep onset latency, sleep duration, time spent awake after sleep onset, and sleep efficiency. These are a standard set of actigraphy-based measurements that are reported in all studies of sleep using actigraphy. Data for each variable will be averaged when obtained over multiple nights. Activity-based measurements will be obtained from the count values summed over a user-specified interval of (15 seconds for this study), resulting in a count value per 15 second epoch. Variables regarding sedentary behaviour and physical activity (in the day time) will be derived from the accelerometer count data using a customised LabView V7 (National Instruments, Austin, TX, USA) program. Daily minutes in each intensity level using validated cutpoints for hip (sedentary <45, light >44, moderate >2028, vigorous >2872 counts per minute) and wrist worn devices (sedentary <209, light >208, moderate >1552, vigorous >4844 counts per minute) will be determined.
The averaged data for each variable will be compared pre- and post-adenotonsillectomy. The significance of the difference between the pre and post measurements will be assessed using the paired T-test with the significance level set at <0.05.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
WA
Recruitment hospital [1] 9039 0
Princess Margaret Hospital - Subiaco
Recruitment hospital [2] 9040 0
Perth Children's Hospital - Nedlands
Recruitment hospital [3] 9041 0
St John of God Hospital, Subiaco - Subiaco
Recruitment hospital [4] 9042 0
St John of God Hospital, Murdoch - Murdoch
Recruitment hospital [5] 11750 0
Subiaco Private Hospital - Subiaco
Recruitment postcode(s) [1] 17521 0
6008 - Subiaco
Recruitment postcode(s) [2] 17522 0
6009 - Nedlands
Recruitment postcode(s) [3] 17523 0
6150 - Murdoch
Recruitment postcode(s) [4] 23836 0
6008 - Subiaco

Funding & Sponsors
Funding source category [1] 297438 0
Charities/Societies/Foundations
Name [1] 297438 0
Perth Children's Hospital Foundation
Address [1] 297438 0
Level 1, 68 Hay St, Subiaco WA 6008
Country [1] 297438 0
Australia
Funding source category [2] 300548 0
Other Collaborative groups
Name [2] 300548 0
Society of Paediatric Anaesthesia New Zealand and Australia
Address [2] 300548 0
SPANZA Secretariat
PO Box 180,
Morisset
NSW 2264
Country [2] 300548 0
Australia
Primary sponsor type
Hospital
Name
Princess Margaret Hospital
Address
Roberts Road
Subiaco
WA 6008
Country
Australia
Secondary sponsor category [1] 296435 0
Individual
Name [1] 296435 0
Prof Britta von Ungern-Sternberg
Address [1] 296435 0
Department of Anaesthesia and Pain Management
Princess Margaret Hospital
Roberts Road
Subiaco
WA 6008
Country [1] 296435 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 298547 0
Children and Adolescent Health Service Human Research Ethics Committee
Ethics committee address [1] 298547 0
Princess Margaret Hospital
Roberts Road
Subiaco
WA 6008
Ethics committee country [1] 298547 0
Australia
Date submitted for ethics approval [1] 298547 0
18/04/2017
Approval date [1] 298547 0
17/08/2017
Ethics approval number [1] 298547 0
RGS00000296
Ethics committee name [2] 298625 0
St John of God Hospital Human Research Ethics Committee
Ethics committee address [2] 298625 0
Suite 304,
25 McCourt St
SUBIACO
WA 6008
Ethics committee country [2] 298625 0
Australia
Date submitted for ethics approval [2] 298625 0
04/09/2017
Approval date [2] 298625 0
15/09/2017
Ethics approval number [2] 298625 0
#1224

Summary
Brief summary
Tonsillectomy is one of the most frequently performed surgical procedures in kids, with approximately ½ million/annum in US, mainly performed as day cases. In Australia, in 2012/13, there were 38575 admissions due to tonsillectomies, representing 724 admissions per 100000 people aged 17 years and under. Sleep disordered breathing (SDB), rather than infection has become the primary reason for tonsillectomy. SDB is defined as an abnormal respiratory pattern during sleep. It presents as a spectrum from simple snoring to severe obstructive sleep apnoea (OSA). The incidence of peri-operative respiratory complications is 10 times higher for children with OSA compared to those without OSA. Perioperative respiratory adverse events necessitating a medical intervention occur in about 10% of children undergoing adenotonsillectomy, 60% of these occur in the immediate post-operative period. However, desaturations can continue for an unpredictable further period of time in a substantial number of children following tonsillectomy.
Currently the gold standard test for assessing presence and severity of OSA/SDB is polysomnography. It is however, a high cost, labour intensive test and is associated with long waiting lists and therefore rarely used in these children. There has been some research on using preoperative oximetry to stratify a patient’s need for more or less observation (e.g. ambulatory surgery, ward special, ICU).
This study will enrol patients scheduled for tonsillectomy and assess their baseline sleep quality via a questionnaire, overnight pulse oximetry and awake-sleep pattern using novel portable activity monitoring devices (ActiCal). These will be performed in the patient’s home prior to surgery. Then any breathing problems within 24 hours of surgery will be recorded. We will then examine if these problems can be predicted from our preoperative measures. If successful this would allow better stratification of risk of patients for tonsillectomy allowing them to get the most appropriate level of post-operative observation required for each individual child.
We will then follow the patients with the same monitors for up to 14 nights after surgery to determine the extent/course of improvement provided by surgery to blood oxygen levels and the impact on sleeping pattern. This will also allow better characterisation of the course of a patient’s night time oxygen levels in the days after surgery, and allow examination of the impact of strong pain killers given around surgery on this parameter. This would help clinicians make more informed decisions in relation to length of stay after surgery. Currently there is very little data to inform these decisions or care pathways. Additionally the activity monitors will help us track the child’s return to normal physical activity which has not previously been assessed objectively. This would allow more evidenced based information to be conveyed to parents about typical recovery after tonsillectomy surgery.
Trial website
None
Trial related presentations / publications
None yet
Public notes

Contacts
Principal investigator
Name 77418 0
Prof Britta von Ungern-Sternberg
Address 77418 0
Department of Anaesthesia and Pain Management
Princess Margaret Hospital
Roberts Road
Subiaco
WA 6008
Country 77418 0
Australia
Phone 77418 0
+61893408109
Fax 77418 0
+61893408755
Email 77418 0
britta.regli-vonungern@health.wa.gov.au
Contact person for public queries
Name 77419 0
Prof Britta von Ungern-Sternberg
Address 77419 0
Department of Anaesthesia and Pain Management
Princess Margaret Hospital
Roberts Road
Subiaco
WA 6008
Country 77419 0
Australia
Phone 77419 0
+61893408109
Fax 77419 0
+61893408755
Email 77419 0
Britta.Regli-VonUngern@health.wa.gov.au
Contact person for scientific queries
Name 77420 0
Prof Britta Regli-von Ungern-Sternberg
Address 77420 0
Department of Anaesthesia and Pain Management
Princess Margaret Hospital
Roberts Road
Subiaco
WA 6008
Country 77420 0
Australia
Phone 77420 0
+61893408109
Fax 77420 0
+61893408755
Email 77420 0
Britta.Regli-VonUngern@health.wa.gov.au

No data has been provided for results reporting
Summary results
Not applicable