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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
23/01/2023
Date data sharing statement initially provided
6/08/2019
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
Sex
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
Completed
Date of first participant enrolment
Anticipated
9/10/2017
Actual
2/02/2018
Date of last participant enrolment
Anticipated
1/02/2021
Actual
3/11/2021
Date of last data collection
Anticipated
1/04/2021
Actual
26/11/2021
Sample size
Target
60
Accrual to date
Final
70
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
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
Country [2] 300548 0
Australia
Funding source category [3] 313031 0
Charities/Societies/Foundations
Name [3] 313031 0
Channel 7 Telethon Trust
Country [3] 313031 0
Australia
Primary sponsor type
Hospital
Name
Perth Children's Hospital
Address
Perth Children's Hospital
15 Hospital Avenue
Nedlands
WA 6009
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
Perth Children's Hospital
15 Hospital Avenue
Nedlands
WA 6009
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
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
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
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 77418 0
Prof Britta von Ungern-Sternberg
Address 77418 0
Department of Anaesthesia and Pain Management
Perth Children's Hospital
15 Hospital Avenue
Nedlands
WA 6009
Country 77418 0
Australia
Phone 77418 0
+61 864564805
Fax 77418 0
Nil
Email 77418 0
[email protected]
Contact person for public queries
Name 77419 0
Britta von Ungern-Sternberg
Address 77419 0
Department of Anaesthesia and Pain Management
Perth Children's Hospital
15 Hospital Avenue
Nedlands
WA 6009
Country 77419 0
Australia
Phone 77419 0
+61 864564805
Fax 77419 0
Nil
Email 77419 0
[email protected]
Contact person for scientific queries
Name 77420 0
Britta Regli-von Ungern-Sternberg
Address 77420 0
Department of Anaesthesia and Pain Management
Perth Children's Hospital
15 Hospital Avenue
Nedlands
WA 6009
Country 77420 0
Australia
Phone 77420 0
+61 864564805
Fax 77420 0
nil
Email 77420 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Recruitment is not completed. No decision taken by investigators


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.