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Trial registered on ANZCTR


Registration number
ACTRN12621001330831
Ethics application status
Approved
Date submitted
3/08/2021
Date registered
29/09/2021
Date last updated
30/08/2022
Date data sharing statement initially provided
29/09/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
Pulse oximeters in Paediatric Patients
Scientific title
The Accuracy of an Inexpensive Pulse Oximeter in Paediatric Patients with Congenital Heart Disease for Potential Use in Low-Middle Income Countries
Secondary ID [1] 304943 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cardiac surgery 323093 0
Condition category
Condition code
Anaesthesiology 320669 320669 0 0
Anaesthetics
Cardiovascular 320673 320673 0 0
Other cardiovascular diseases
Surgery 320947 320947 0 0
Other surgery

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Intraoperatively, the patients will be monitored as per usual anaesthetic standards, including heart rate, blood pressure, temperature, and pulse oximetry. When the anaesthetic team deems it time to draw a baseline arterial blood gas, per routine clinical management of the patient, the study pulse oximeter (Contec Pulse Oximeter, model CMS50DL) will be placed on one of the patient’s digits. Attempts will be made to place the study pulse oximeter on the same limb as the arterial line, if patient body size allows and particularly if a patent ductus arteriosus exists. Moreover, the study pulse oximeter will be placed on the same limb as the standard pulse oximeter, pending a patient’s body size. The oximeter reading will be allowed to reach a plateau, which will be defined as the consistent reading fifteen seconds after being placed on the patient. After obtaining said plateau after fifteen seconds, the arterial blood gas will be drawn and the patient’s SpO2 from the standard pulse oximeter, heart rate from the standard pulse oximeter or electrocardiogram tracing, SpO2 and heart rate from the study pulse oximeter, arterial blood pressure, oesophageal or nasopharyngeal temperature, skin temperature near the site of oximetry, arterial blood gas haemoglobin, and arterial blood gas co-oximetry values will be recorded and used for comparison. Notably, if unable to place both oximeters on the same limb because of small patient body size, the aforementioned standard RCH pulse oximeter will be the pulse oximeter located in a similar location as to the study pulse oximeter with regards to a patent ductus arteriosus or coarctation of the aorta.
It is anticipated that the duration of participation should be approximately five minutes per sample, allowing for placement of study pulse oximeter, waiting for the fifteen second plateau, and recording of the values previously mentioned.
Participants or their caregivers will also be asked to complete a demographic/characteristic survey.
Skin type will also be assessed by using the Fitzpatrick scale.
Intervention code [1] 321341 0
Not applicable
Comparator / control treatment
The accuracy of the study oximeter will be compared to usual pulse oximetry readings used at The Royal Children's Hospital Melbourne and and arterial blood gas co-oximetry values, as defined by ISO standards.

Attempts will be made to place the study pulse oximeter on the same limb as the arterial line, if patient body size allows and particularly if a patent ductus arteriosus exists. Moreover, the study pulse oximeter will be placed on the same limb as the standard pulse oximeter, pending a patient’s body size. Notably, if unable to place both oximeters on the same limb because of small patient body size, the aforementioned standard pulse oximeter will be located in a similar location as to the study pulse oximeter with regards to a patent ductus arteriosus or coarctation of the aorta.

Note that there are a range of 'standard' pulse oximeters used at RCH.
Control group
Active

Outcomes
Primary outcome [1] 328492 0
Accuracy compared to standard pulse oximeter.

Accuracy will be determined by using comparison of oxygen saturation measured by study pulse oximeter compared to oxygen saturation measured by standard pulse oximeter,
Timepoint [1] 328492 0
During cardiac surgery, at the time of drawing the usual baseline arterial blood gas, after the study pulse oximeter has been placed on the patient and allowed to reach a plateau after fifteen seconds.
Primary outcome [2] 328873 0
Accuracy compared to co-oximetry measurements.

Accuracy willl be determined using comparison of oxygen saturation from arterial blood gas measurements with study pulse oximeter readings.
Timepoint [2] 328873 0
During cardiac surgery, at the time of drawing the usual baseline arterial blood gas, after the study pulse oximeter has been placed on the patient and allowed to reach a plateau after fifteen seconds.
Secondary outcome [1] 399179 0
Accuracy of study pulse oximeter compared to co-oximetry values in patients with skin types I-VI according to Fitzpatrick scale categories.
Timepoint [1] 399179 0
During cardiac surgery, at the time of drawing the usual baseline arterial blood gas, after the study pulse oximeter has been placed on the patient and allowed to reach a plateau after fifteen seconds.
Secondary outcome [2] 400757 0
Heart rate beats per minute (bpm)
Timepoint [2] 400757 0
Heart rate will be measured from the usual standard pulse oximeter or electrocardiogram tracing as well as the study oximeter.

During cardiac surgery, at the time of drawing the usual baseline arterial blood gas, after the study pulse oximeter has been placed on the patient and allowed to reach a plateau after fifteen seconds.
Secondary outcome [3] 400758 0
Arterial blood pressure: millimetres of mercury (mmHg)
Timepoint [3] 400758 0
During cardiac surgery, at the time of drawing the usual baseline arterial blood gas, after the study pulse oximeter has been placed on the patient and allowed to reach a plateau after fifteen seconds.
Secondary outcome [4] 400759 0
Skin temperature near the site of oximetry: degrees Celsius
Timepoint [4] 400759 0
During cardiac surgery, at the time of drawing the usual baseline arterial blood gas, after the study pulse oximeter has been placed on the patient and allowed to reach a plateau after fifteen seconds.
Secondary outcome [5] 400760 0
Oesophageal or nasopharyngeal temperature: degrees Celsius
Timepoint [5] 400760 0
During cardiac surgery, at the time of drawing the usual baseline arterial blood gas, after the study pulse oximeter has been placed on the patient and allowed to reach a plateau after fifteen seconds.
Secondary outcome [6] 400761 0
Arterial blood gas haemoglobin: grams per litre (g/L)
Timepoint [6] 400761 0
During cardiac surgery, at the time of drawing the usual baseline arterial blood gas, after the study pulse oximeter has been placed on the patient and allowed to reach a plateau after fifteen seconds.

Eligibility
Key inclusion criteria
• Under the age of eighteen years old
• Undergoing cardiac surgery requiring placement of an arterial line for routine clinical care at The Royal Children's Hospital Melbourne
• Has a legally acceptable representative capable of understanding the study information sheet and providing verbal consent on the participant’s behalf
• Completes the patient demographic/characteristic survey or has a legally acceptable representative capable of understanding the survey who completes it on the participant’s behalf
Minimum age
1 Days
Maximum age
17 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
• Is classified as not having pulsatile peripheral flow, as in the setting of a ventricular assist device

Participants may also be excluded if they have previously participated in this study, pending enrolment numbers.

Study design
Purpose
Natural history
Duration
Cross-sectional
Selection
Defined population
Timing
Prospective
Statistical methods / analysis
The statistical analysis plan for pulse oximetry device was based on recommendations from ISO80601-2-61:2017.

Bias, precision, and room mean square error (RMS) will be reported across a decade of oxygen saturation, e.g. 70%-80%. Bias will be calculated as SpO2 – SaO2. Precision will be calculated as the standard deviation of bias with adjustments for patients with multiple measurements as in “true value varies” method as detailed in Bland and Altman 2007.

Root mean square (Arms) will be calculated by the square root of the difference between SpO2 and SaO2, squared. An Arms less than 4% is regarded by the ISO as the standard for pulse oximeters.

A Bland-Altman plot of SpO2-SaO2 versus SaO2 will be created with mean, linear regression, and 95% upper and lower values. A scatter plot between will also be created.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
13/10/2021
Actual
5/10/2021
Date of last participant enrolment
Anticipated
30/06/2023
Actual
Date of last data collection
Anticipated
30/06/2023
Actual
Sample size
Target
100
Accrual to date
40
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 20131 0
The Royal Childrens Hospital - Parkville
Recruitment postcode(s) [1] 34852 0
3052 - Parkville

Funding & Sponsors
Funding source category [1] 309333 0
Hospital
Name [1] 309333 0
The Royal Children's Hospital Melbourne
Country [1] 309333 0
Australia
Primary sponsor type
Hospital
Name
The Royal Children's Hospital Melbourne
Address
50 Flemington Road, Parkville, Victoria 3052
Country
Australia
Secondary sponsor category [1] 310298 0
Other
Name [1] 310298 0
Murdoch Children’s Research Institute (MCRI)
Address [1] 310298 0
50 Flemington Road, Parkville, Victoria 3052
Country [1] 310298 0
Australia
Secondary sponsor category [2] 310300 0
University
Name [2] 310300 0
University of Melbourne
Address [2] 310300 0
University of Melbourne, Parkville, Victoria 3010
Country [2] 310300 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 309151 0
The Royal Children's Hospital Human Research Ethics Committee
Ethics committee address [1] 309151 0
50 Flemington Road, Parkville, Victoria 3052
Ethics committee country [1] 309151 0
Australia
Date submitted for ethics approval [1] 309151 0
14/07/2021
Approval date [1] 309151 0
02/09/2021
Ethics approval number [1] 309151 0

Summary
Brief summary
Paediatric patients undergoing cardiac surgery at the Royal Children’s Hospital in Melbourne (RCH) will have a study pulse oximeter (Contec Pulse Oximeter, model CMS50DL) placed on a digit when an arterial blood gas is being drawn for routine clinical management. At this time, the patient’s vital signs and specific values from the arterial blood gas measurements will be recorded and, ultimately, the usual RCH pulse oximetry readings and arterial blood gas co-oximetry values will be compared with study pulse oximeter readings. All paediatric patients undergoing cardiac surgery at RCH during the specified time period will be eligible and may be subjects in this study. Patients and/or the patient’s legally acceptable representative will be provided with a study information sheet. Verbal consent will be obtained for all patients. Patients and/or the patient’s legally acceptable representative will also be asked to fill out a survey as part of the study.

Study hypothesis: We are conducting this study to test whether a low-priced pulse oximeter (a medical device to measure the amount of oxygen in the blood) is accurate in paediatric patients, particularly those undergoing cardiac surgery.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 113162 0
Dr Katheryne Lawson
Address 113162 0
Department of Anaesthesia & Pain Management
The Royal Children's Hospital
50 Flemington Road, Parkville, Victoria 3052
Country 113162 0
Australia
Phone 113162 0
+61 3 9345 5233
Fax 113162 0
Email 113162 0
[email protected]
Contact person for public queries
Name 113163 0
Dr Katheryne Lawson
Address 113163 0
Department of Anaesthesia & Pain Management
The Royal Children's Hospital
50 Flemington Road, Parkville, Victoria 3052
Country 113163 0
Australia
Phone 113163 0
+61 3 9345 5233
Fax 113163 0
Email 113163 0
[email protected]
Contact person for scientific queries
Name 113164 0
Dr Katheryne Lawson
Address 113164 0
Department of Anaesthesia & Pain Management
The Royal Children's Hospital
50 Flemington Road, Parkville, Victoria 3052
Country 113164 0
Australia
Phone 113164 0
+61 3 9345 5233
Fax 113164 0
Email 113164 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
The data included will be:
• Patient demographics and characteristics
• Observational vital signs to include SpO2, heart rate, arterial blood pressure, and temperature
• Arterial blood gas haemoglobin and co-oximetry values
When will data be available (start and end dates)?
After data analysis and article publication.
No end date for when data will be not be made available.
Available to whom?
Future researchers from a recognised research institution
Available for what types of analyses?
Analyses which have been ethically reviewed and approved by an independent committee and who accept the Murdoch Children's Research Institute's conditions for access.
How or where can data be obtained?
Contacting the Principal Investigator by email: [email protected]


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
12752Study protocol  [email protected]
12753Statistical analysis plan  [email protected]



Results publications and other study-related documents

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No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.