Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12623001318673p
Ethics application status
Submitted, not yet approved
Date submitted
8/11/2023
Date registered
15/12/2023
Date last updated
15/12/2023
Date data sharing statement initially provided
15/12/2023
Type of registration
Prospectively registered

Titles & IDs
Public title
A study exploring the use of continuous vital sign monitoring in acutely unwell general medical inpatients.
Scientific title
Automated vital sign monitoring devices in acutely unwell general medical inpatients: an exploratory study
Secondary ID [1] 310623 0
None
Universal Trial Number (UTN)
U1111-1298-3702
Trial acronym
VitalDetect
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Impaired respiratory function 331542 0
Tachycardia 331543 0
Hypoxia 331544 0
Bradycardia 332151 0
Hyperoxaemia 332266 0
Condition category
Condition code
Public Health 328279 328279 0 0
Health service research

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
This observational study explores the use of breathing and heart rate measurement devices that provide continuous monitoring of unwell hospital inpatients. These devices non-invasively detect patient observations and communicate with a centralised computer. Using these devices, patient observations can be automatically collected and displayed for the use of medical staff caring for the patient.

This study involves three new monitoring devices; one that attaches to the chest wall device with an adhesive patch to measure respiratory rate, one that is worn around the wrist with a strap and has a finger probe attached to measure heart rate and oxygen saturation, and another that is placed underneath the patient’s mattress and can measure heart rate and respiratory rate.

The study is designed in two parts; the first to assess the agreement between vital sign recordings using novel devices compared to gold standard measurements, and the second to compare continuous vital sign monitoring with standard intermittent nursing observations.

A total of 27 people who provide informed consent to join both parts (Part 1 and Part 2) of the study will be monitored with these three devices for 48 hours while in hospital. Each participant will have all three devices applied by a study investigator. The participants care while in hospital will not be influenced by their involvement in the study. Nurses will continue to monitor participants as they normally would, and the device measurements will not be visible to hospital staff during the study.
Intervention code [1] 327056 0
Early Detection / Screening
Comparator / control treatment
In the first 15 minutes the respiratory rate measured by the three devices will be compared to simultaneous recordings using nasal prongs detecting the rate of carbon dioxide expiration, the 'gold standard' measurement of respiratory rate.
Nursing staff will be instructed to measure vital signs in accordance with their normal practice and document these on their ward vitals charts. Respiratory rate is measured by nursing observation. Oxygen supplementation is measured by nursing observation. Oxygen saturation is measured by pulse oximetry. Heart rate is measured by pulse oximetry or nursing palpation. Blood pressure is measured by manual or automatic sphygmomanometer. Temperature is measured by tympanic thermometer. Level of consciousness is measured by nursing observation. Frequency of measurements is dependent on each patient's needs and may vary from every 10 minutes to every 12 hours.
Control group
Active

Outcomes
Primary outcome [1] 336134 0
To establish the level of agreement of RR (respiratory rate) measurements between capnography and both a chest-wall device and a noncontact device
Timepoint [1] 336134 0
15 minutes of paired measurements across devices obtained at beginning of trial (mean of 15-minute period will be used)
Primary outcome [2] 336136 0
To determine the distribution of total EWS (early warning score) scores
Timepoint [2] 336136 0
48-hour period of continuous measurements from the time of device placement (the mean of continuous RR over 10-, 30- and 60-minute periods will be used)
Secondary outcome [1] 426986 0
To establish the level of agreement between heart rate (HR) measurements across different measurement strategies
Timepoint [1] 426986 0
15 minutes of paired measurements across devices obtained at beginning or trial (mean of 15-minute period will be used)
Secondary outcome [2] 426988 0
To determine the reliability of data capture by chest-wall device
Timepoint [2] 426988 0
48-hour period of continuous measurements from the time of device placement
Secondary outcome [3] 426989 0
To determine the reliability of data capture by noncontact device
Timepoint [3] 426989 0
48-hour period of continuous measurements from the time of device placement
Secondary outcome [4] 426990 0
To determine the reliability of data capture by pulse oximetry
Timepoint [4] 426990 0
48-hour period of continuous measurements from the time of device placement
Secondary outcome [5] 426993 0
To determine the distribution of intermittent RR by nursing observations over 48 hours
Timepoint [5] 426993 0
48-hour period of continuous measurements from the time of device placement
Secondary outcome [6] 426995 0
To determine the distribution of intermittent HR by nursing observations over 48 hours
Timepoint [6] 426995 0
48-hour period of continuous measurements from the time of device placement
Secondary outcome [7] 426996 0
To determine the distribution of intermittent SpO2 by nursing observations over 48 hours
Timepoint [7] 426996 0
48-hour period of continuous measurements from the time of device placement
Secondary outcome [8] 426997 0
To determine the distribution of intermittent supplemental oxygen by nursing observations over 48 hours
Timepoint [8] 426997 0
48-hour period of continuous measurements from the time of device placement
Secondary outcome [9] 426998 0
To determine the distribution of intermittent temperature by nursing observations over 48 hours
Timepoint [9] 426998 0
48-hour period of continuous measurements from the time of device placement
Secondary outcome [10] 426999 0
To determine the distribution of intermittent systolic blood pressure (SBP) by nursing observations over 48 hours
Timepoint [10] 426999 0
48-hour period of continuous measurements from the time of device placement
Secondary outcome [11] 427000 0
To determine the distribution of intermittent level of consciousness (LOC) by nursing observations over 48 hours
Timepoint [11] 427000 0
48-hour period of continuous measurements from the time of device placement
Secondary outcome [12] 427001 0
To determine the distribution of continuously measured RR using a chest-wall device
Timepoint [12] 427001 0
48-hour period of continuous measurements from the time of device placement (the mean of continuous RR over 10-, 30- and 60-minute periods will be used)
Secondary outcome [13] 427007 0
To determine the distribution of continuously measured RR using a noncontact device
Timepoint [13] 427007 0
48-hour period of continuous measurements from the time of device placement (the mean of continuous RR over 10-, 30- and 60-minute periods will be used)
Secondary outcome [14] 427008 0
To determine the distribution of continuously measured HR using a noncontact device
Timepoint [14] 427008 0
48-hour period of continuous measurements from the time of device placement (the mean of continuous HR over 10-, 30- and 60-minute periods will be used)
Secondary outcome [15] 427009 0
To determine the distribution of continuously measured HR using pulse oximetry
Timepoint [15] 427009 0
48-hour period of continuous measurements from the time of device placement (the mean of continuous HR over 10-, 30- and 60-minute periods will be used)
Secondary outcome [16] 427010 0
To determine the distribution of continuously measured SpO2 using pulse oximetry
Timepoint [16] 427010 0
48-hour period of continuous measurements from the time of device placement (the mean of continuous SpO2 over 10-, 30- and 60-minute periods will be used)
Secondary outcome [17] 427019 0
To describe the time-course of RR in the individual participants for whom MET call criteria are met
Timepoint [17] 427019 0
48-hour period of continuous measurements from the time of device placement
Secondary outcome [18] 429650 0
To determine the reliability of data capture by noncontact device
Timepoint [18] 429650 0
48-hour period of continuous measurements from the time of device placement
Secondary outcome [19] 429651 0
To determine the reliability of data capture by pulse oximetry
Timepoint [19] 429651 0
48-hour period of continuous measurements from the time of device placement
Secondary outcome [20] 429676 0
To describe the time-course of HR in the individual participants for whom MET call criteria are met
Timepoint [20] 429676 0
48-hour period of continuous measurements from the time of device placement
Secondary outcome [21] 429677 0
To describe the time-course of SpO2 in the individual participants for whom MET call criteria are met
Timepoint [21] 429677 0
48-hour period of continuous measurements from the time of device placement
Secondary outcome [22] 429678 0
To describe the time-course of blood pressure in the individual participants for whom MET call criteria are met
Timepoint [22] 429678 0
48-hour period of continuous measurements from the time of device placement
Secondary outcome [23] 429679 0
To describe the time-course of level of consciousness in the individual participants for whom MET call criteria are met
Timepoint [23] 429679 0
48-hour period of continuous measurements from the time of device placement
Secondary outcome [24] 429680 0
To describe the time-course of temperature in the individual participants for whom MET call criteria are met
Timepoint [24] 429680 0
48-hour period of continuous measurements from the time of device placement
Secondary outcome [25] 429681 0
To describe the time-course of supplemental oxygen in the individual participants for whom MET call criteria are met
Timepoint [25] 429681 0
48-hour period of continuous measurements from the time of device placement

Eligibility
Key inclusion criteria
• Patients admitted under a medical team <24 hours
• Anticipated to remain an inpatient in Wellington hospital for >24 hours
• EWS =/> 4 at time of eligibility assessment
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
• Age <18
• Planned surgical intervention requiring transfer to an operating theatre within 24 hours
• Cardiac pacemaker
• Primarily receiving end of life care (Goals of Care D)
• HDB/ICU admissions
• Invasive/non-invasive ventilation
• Imminent need for ICU admission (currently planning for ICU admission)
• Meeting MET call criteria at eligibility assessment (EWS =/>10 or any parameter in ‘blue zone’)
• Practical reasons that a chest wall sensing device cannot be applied (MRI scanner, skin disease, dressings, etc.)
• Cognitive impairment or impaired consciousness precluding informed consent and ability to co-operate with application of continuous monitoring devices
• Pregnancy or breastfeeding

Study design
Purpose
Natural history
Duration
Cross-sectional
Selection
Defined population
Timing
Prospective
Statistical methods / analysis
A per protocol analysis will include all participants enrolled in the study for a minimum of 24 hours. Participants who do not complete 24 hours of the study will be replaced.
For the part 1 primary analysis, the chest wall and non-contact devices RR and HR measurements will be compared to capnography and telemetry respectively; with the mean difference (bias) and calculated limits of agreement (plus or minus two paired standard deviations) displayed in Bland-Altman plots.

For the part 2 primary analysis, and for other endpoints describing the distribution of continuous variables, the data will be rounded to an integer for analysis and summarised by mean and standard deviation, median and interquartile range (25th to 75th percentile), and minimum to maximum. Categorical data are summarised by counts and proportions expressed as percentages.

For endpoints describing the time course of measured variables, data will be shown graphically by scatter plots of the raw and paired data with Locally Estimated Scatter Plot Smoother (LOESS) and approximate 95% confidence intervals.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
18/12/2023
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
27
Accrual to date
Final
Recruitment outside Australia
Country [1] 25779 0
New Zealand
State/province [1] 25779 0

Funding & Sponsors
Funding source category [1] 314869 0
Commercial sector/Industry
Name [1] 314869 0
Fisher & Paykel Healthcare Ltd
Country [1] 314869 0
New Zealand
Primary sponsor type
Commercial sector/Industry
Name
Fisher & Paykel Healthcare Limited
Address
15 Maurice Paykel Place, East Tamaki, Auckland 2013, NZ
Country
New Zealand
Secondary sponsor category [1] 316865 0
None
Name [1] 316865 0
Address [1] 316865 0
Country [1] 316865 0

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 313841 0
Central Health and Disability Ethics Committee
Ethics committee address [1] 313841 0
Ministry of Health Health and Disability Ethics Committees PO Box 5013 Wellington 6140
Ethics committee country [1] 313841 0
New Zealand
Date submitted for ethics approval [1] 313841 0
20/09/2023
Approval date [1] 313841 0
Ethics approval number [1] 313841 0

Summary
Brief summary
This observational study explores the use of three breathing and heart rate measurement devices that provide continuous monitoring of unwell hospital inpatients. One device attaches to the chest wall device with an adhesive patch to measure respiratory rate, a second device is worn around the wrist with a strap and has a finger probe attached to measure heart rate and oxygen saturation, and a third device is placed underneath the patient’s mattress and can measure heart rate and respiratory rate. People who provide informed consent to join the study will be monitored with these three devices for 48 hours while in hospital. The participants care while in hospital will not be influenced by their involvement in the study. Nurses will continue to monitor participants as they normally would, and the device measurements will not be visible to hospital staff during the study. The information gathered from the trial will be used to determine whether the new devices are accurate and reliable. Secondly this study will look at the influence of continuous breathing and heart rate monitoring on the New Zealand Early Warning Score system (NZEWS).
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 129518 0
Dr Julie Cook
Address 129518 0
7 CSB Building Wellington Hospital, Riddiford Street, Newtown, Wellington 6021
Country 129518 0
New Zealand
Phone 129518 0
+6448050147
Fax 129518 0
Email 129518 0
julie.cook@mrinz.ac.nz
Contact person for public queries
Name 129519 0
Dr Julie Cook
Address 129519 0
7 CSB Building Wellington Hospital, Riddiford Street, Newtown, Wellington 6021
Country 129519 0
New Zealand
Phone 129519 0
+6448050147
Fax 129519 0
Email 129519 0
julie.cook@mrinz.ac.nz
Contact person for scientific queries
Name 129520 0
Dr Julie Cook
Address 129520 0
7 CSB Building Wellington Hospital, Riddiford Street, Newtown, Wellington 6021
Country 129520 0
New Zealand
Phone 129520 0
+6448050147
Fax 129520 0
Email 129520 0
julie.cook@mrinz.ac.nz

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
Data are available on reasonable request. Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures and appendices) will be made available.
When will data be available (start and end dates)?
Only after publication until a minimum of 10 years after publication.
Available to whom?
To researchers who provide a methodologically sound proposal that has been approved by the study study steering committee and sponsor
Available for what types of analyses?
For analyses supported by a methodologically sound proposal that has been approved by the study study steering committee and sponsor to achieve the aims outlined in the approved proposal
How or where can data be obtained?
Access to individual data is possible through a signed data access agreement and subject to approval by the principal investigator (julie.cook@mrinz.ac.nz) and the study sponsor (Brett.Huddart@fphcare.co.nz)


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.