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Trial registered on ANZCTR


Registration number
ACTRN12622000677707
Ethics application status
Approved
Date submitted
3/05/2022
Date registered
10/05/2022
Date last updated
10/05/2022
Date data sharing statement initially provided
10/05/2022
Type of registration
Prospectively registered

Titles & IDs
Public title
Assessment of the reliability and usability of pulse oximetry and thermometers performed by patients
Scientific title
Single group assessment of the reliability and usability of pulse oximetry performed by patients
Secondary ID [1] 306959 0
This study is funded by an MRFF – Coronavirus Research Response - 2020 Rapid Response Digital Health Infrastructure grant, Application ID RRDHI000011.
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
COVID-19 326073 0
Condition category
Condition code
Infection 323384 323384 0 0
Other infectious diseases
Respiratory 323385 323385 0 0
Other respiratory disorders / diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This study will focus on the reliability and acceptability of the iHealth Air pulse oximeter and iHealth thermometer when combined with the newly developed software interface to the electronic medical record. The iHealth Air pulse oximeter is currently used in rpaVirtual, and although it is blue-tooth enabled, its readings are entered manually into the electronic medical record by clinical staff. Sydney Local Health District ICT have developed a software interface that permits pulse rate and SpO2 data from the iHealth Air and skin temperature from iHealth thermometer to be recorded directly into the electronic medical record via an iPhone application using blue-tooth transmission. This study will evaluate the iHealth Air & iHealth Thermometer-eMR interface package.

Participants will be recruited amongst inpatients at Royal Prince Alfred hospital. Participants will be given an iHealth Air pulse oximeter, an iHealth thermometer and an iPhone preloaded with the required software application. A researcher will provide in-person training to the participant in how to use the devices, and answer any questions that they have. The participant will also be given a written education materials to refer to during the trial.

Over a 24 hour period, participants will hold the thermometer up to their forehead to measure temperature and apply the pulse oximeter to the target finger to measure their pulse rate and SpO2 on each occasion that the nursing staff take the routine vital sign observations. They will be encouraged to do so as soon as possible after the nurse completes the observations, approximately every 6 hours. They will also record whether they had any difficulties in using the thermometer, oximeter or mobile phone in the patient logbook. The logbook can be on-line or paper-based according to patient preference.

At the end of the 24 hour period, participants will fill in the acceptability questionnaire and the researcher will collect the thermometer, the oximeter and the iPhone together with the filled in forms. The acceptability questionnaire can be completed on-line or in hard copy as preferred by the participant.

It is NSW health policy that patients in hospital have observations including oximetry every 6 hours unless otherwise decided by their treating team. The patient will not be woken up specifically for research, but only as the clinical requirements indicate.
Intervention code [1] 323404 0
Early detection / Screening
Comparator / control treatment
There is no control group for this study, however the measurements taken with the intervention devices will be compared the clinical measurements taken by nursing staff over the same 24 hour period.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 331126 0
Determine the proportion of readings using the iHealth Air & iHealth Thermometer-eMR interface package that give results in the eMR
Timepoint [1] 331126 0
Device readings will be taken approximately every 6 hours over the 24-hour trial period, and will instantly be uploaded into the eMR.
Primary outcome [2] 331127 0
Investigate the acceptability to patients of the iHealth Air & iHealth Thermometer-eMR interface package
Timepoint [2] 331127 0
Participants will complete an acceptability survey once at the end of the 24-hour trial period.

The acceptability survey is based on the theoretical framework of acceptability and has sections on task load index (National Aeronautics & Space Administration 1986), system usability and technology acceptance.
Secondary outcome [1] 408858 0
Determine the proportion of readings using the iHealth Air-eMR interface package that give a result in the eMR
Timepoint [1] 408858 0
Device readings will be taken approximately every 6 hours over the 24-hour trial period, and will instantly be uploaded into the eMR.
Secondary outcome [2] 408859 0
Determine the proportion of readings using the iHealth thermometer-eMR interface package that give a result in the eMR
Timepoint [2] 408859 0
Device readings will be taken approximately every 6 hours over the 24-hour trial period, and will instantly be uploaded into the eMR.
Secondary outcome [3] 408860 0
Identify the causes (recorded in the patient logbook) of readings failing to be transmitted into the eMR
Timepoint [3] 408860 0
Device readings will be taken approximately every 6 hours over the 24-hour trial period, and will instantly be uploaded into the eMR.

Participants will complete a logbook after taking each device measurement.
Secondary outcome [4] 408861 0
Evaluate the percentage of SpO2 readings that are abnormal on the iHealth Air device, but normal on routine nurse-administered clinical oximetry device
Timepoint [4] 408861 0
Device readings will be taken approximately every 6 hours over the 24-hour trial period, and will instantly be uploaded into the eMR.
Secondary outcome [5] 408862 0
Evaluate the percentage of SpO2 readings that are normal on the iHealth Air device, but abnormal on routine nurse-administered clinical oximetry device
Timepoint [5] 408862 0
Device readings will be taken approximately every 6 hours over the 24-hour trial period, and will instantly be uploaded into the eMR.
Secondary outcome [6] 408863 0
Evaluate the percentage of readings of pulse rate that are abnormal on the iHealth Air device, but normal on routine nurse measurement
Timepoint [6] 408863 0
Device readings will be taken approximately every 6 hours over the 24-hour trial period, and will instantly be uploaded into the eMR.
Secondary outcome [7] 408864 0
Evaluate the percentage of readings of pulse rate that are normal on the iHealth Air device, but abnormal on routine nurse measurement
Timepoint [7] 408864 0
Device readings will be taken approximately every 6 hours over the 24-hour trial period, and will instantly be uploaded into the eMR.
Secondary outcome [8] 408865 0
Evaluate the percentage of readings that are abnormal on the iHealth thermometer, but normal on routine nurse-administered clinical thermometer
Timepoint [8] 408865 0
Device readings will be taken approximately every 6 hours over the 24-hour trial period, and will instantly be uploaded into the eMR.
Secondary outcome [9] 408866 0
Evaluate the percentage of readings that are normal on the iHealth thermometer, but abnormal on routine nurse-administered clinical thermometer
Timepoint [9] 408866 0
Device readings will be taken approximately every 6 hours over the 24-hour trial period, and will instantly be uploaded into the eMR.
Secondary outcome [10] 408867 0
Measure the agreement between the readings in iHealth Air with eMR linkage and routine nurse-administered clinical oximetry using Bland-Altman analysis for bias, precision and limits of agreement
Timepoint [10] 408867 0
Device readings will be taken approximately every 6 hours over the 24-hour trial period, and will instantly be uploaded into the eMR.
Secondary outcome [11] 408868 0
Measure the agreement between pulse rate measured by iHealth Air with eMR linkage and clinically measured pulse rate (Bland-Altman analysis for bias, precision and limits of agreement)
Timepoint [11] 408868 0
Device readings will be taken approximately every 6 hours over the 24-hour trial period, and will instantly be uploaded into the eMR.
Secondary outcome [12] 408869 0
Measure the agreement between temperature measured by iHealth thermometer with eMR linkage and clinically measured temperature (Bland-Altman analysis for bias, precision and limits of agreement)
Timepoint [12] 408869 0
Device readings will be taken approximately every 6 hours over the 24-hour trial period, and will instantly be uploaded into the eMR.
Secondary outcome [13] 408870 0
Compare the sensitivity and specificity of the iHealth Air with eMR linkage and routine nurse-administered clinical oximetry for detecting SpO2 below 95%
Timepoint [13] 408870 0
Device readings will be taken approximately every 6 hours over the 24-hour trial period, and will instantly be uploaded into the eMR.
Secondary outcome [14] 408871 0
Compare the sensitivity and specificity of the iHealth Thermometer with eMR linkage and routine nurse-administered clinical oximetry for detecting temperature in the abnormal range of <35.5°C or >38.5°C
Timepoint [14] 408871 0
Device readings will be taken approximately every 6 hours over the 24-hour trial period, and will instantly be uploaded into the eMR.

Eligibility
Key inclusion criteria
1. Age >= 18 years
2. Able to give informed consent
3. Able to understand and carry out the requirements of the study
4. Able to read and write in English
5. Clinically stable
6. Likely to remain on ward for 24 hours or more
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Injuries or infections on target finger
2. Nail polish or false nails on target finger (unless the participant is willing to remove the nail polish)
3. Major psychiatric illness, delirium and/or dementia
4. Being continuously monitored with an oximeter
5. Unable to obtain stable oximetry reading using standard clinical oximetry
6. In the judgement of the investigator, unlikely to be able to carry out the requirements of the study

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)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Safety
Statistical methods / analysis
The study will recruit a convenience sample of approximately 50 participants.

The data will be summarised and presented as mean, standard deviation (normal data), median, inter-quartile range (skewed data or ordinal data), proportions, with 95% confidence intervals. The confidence intervals of proportion of all the variables in the main and secondary objectives will be based on the Wilson score method, which has been shown to be a safe and robust choice even for small samples and skewed data (Wallis 2013). The agreement between the clinical observations and the iHealth devices will be assessed by Bland-Altman analysis as modified for repeated measures in individuals (Bland and Altman 2007). In this agreement and accuracy analysis, metrics of bias (mean difference), precision (SD of the differences), and limits of agreement (bias ± 1.96 SD) will be reported. The agreement analysis will be presented using Bland – Altman plot. The accuracy value, also called the ARMS (accuracy root means squared), will be computed and compared with the recommended cut-off value (Accuracy = <3.0, (Luks and Swenson 2020)). Sensitivity and specificity of observations with the clinical devices and of the iHealth devices with eMR interface will be compared by the methodology of Lachenbruch and Lynch (Lachenbruch and Lynch 1998).

The patient survey modelled based on the theoretical framework of acceptability has sections on task load index (National Aeronautics & Space Administration 1986), system usability and technology acceptance. The task load index, system usability and technology acceptance, measured using Likert scale items will be summarized using mean, range and standard deviation. Reliability of the scales of each component construct in the theoretical framework of acceptability will be assessed using Cronbach’s alpha measure for internal consistency with Cronbach’s alpha value 0.70 or greater considered as evidence for satisfactory reliability (Hair et al., 2010). A single group test for mean/median will be performed to assess the degree of usability and different aspects of acceptability of the oximeter and thermometer.

All the statistical tests will be performed at a .05 level of significance. All statistical analyses will be performed in SAS V9.4.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
25/05/2022
Actual
Date of last participant enrolment
Anticipated
30/09/2022
Actual
Date of last data collection
Anticipated
7/10/2022
Actual
Sample size
Target
50
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 22311 0
Royal Prince Alfred Hospital - Camperdown
Recruitment postcode(s) [1] 37472 0
2050 - Camperdown

Funding & Sponsors
Funding source category [1] 311059 0
Government body
Name [1] 311059 0
Medical Research Future Fund (MRFF)
Country [1] 311059 0
Australia
Primary sponsor type
Hospital
Name
Royal Prince Alfred Hospital
Address
50 Missenden Rd
Camperdown
NSW 2050
Country
Australia
Secondary sponsor category [1] 312748 0
None
Name [1] 312748 0
Address [1] 312748 0
Country [1] 312748 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 310604 0
RPAH Human Research Ethics Committee
Ethics committee address [1] 310604 0
Ethics committee country [1] 310604 0
Australia
Date submitted for ethics approval [1] 310604 0
26/10/2021
Approval date [1] 310604 0
10/12/2021
Ethics approval number [1] 310604 0
X21-0385 & 2021/ETH11865

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 118234 0
A/Prof Edmund Lau
Address 118234 0
Level 11, Department of Respiratory and Sleep Medicine
Royal Prince Alfred Hospital
Missenden Rd Camperdown NSW 2050
Country 118234 0
Australia
Phone 118234 0
+61 2 9515 8195
Fax 118234 0
+61 2 9515 8196
Email 118234 0
[email protected]
Contact person for public queries
Name 118235 0
Karen Allison
Address 118235 0
Level 9, King George V Building
Missenden Rd
Camperdown NSW 2050
Country 118235 0
Australia
Phone 118235 0
+61 2 9515 6111
Fax 118235 0
Email 118235 0
[email protected]
Contact person for scientific queries
Name 118236 0
Karen Allison
Address 118236 0
Level 9, King George V Building
Missenden Rd
Camperdown NSW 2050
Country 118236 0
Australia
Phone 118236 0
+61 2 9515 6111
Fax 118236 0
Email 118236 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


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.