Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12620000728932
Ethics application status
Approved
Date submitted
29/05/2020
Date registered
13/07/2020
Date last updated
13/07/2020
Date data sharing statement initially provided
13/07/2020
Type of registration
Prospectively registered

Titles & IDs
Public title
Continuous pulse oximetry in medical patients admitted to hospital who require oxygen
Scientific title
Determination of peripheral oxygen saturation compared to a prescribed target range using continuous pulse oximetry in adults admitted to Wellington Regional Hospital who require oxygen therapy
Secondary ID [1] 301398 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Acutely unwell patients who require oxygen therapy in hospital 317655 0
Pneumonia 317852 0
Asthma 317853 0
Chronic obstructive pulmonary disease 317854 0
Heart failure 317855 0
Condition category
Condition code
Respiratory 315737 315737 0 0
Chronic obstructive pulmonary disease
Respiratory 315738 315738 0 0
Asthma
Respiratory 315739 315739 0 0
Other respiratory disorders / diseases

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
In this observational study, patients who have been admitted to Wellington Regional Hospital and Hutt Hospital for an acute illness who are receiving oxygen therapy will be recruited. Patients will be required to have a target peripheral oxygen saturation (SpO2) range prescribed to be included in the study. Enrolled participants will have SpO2 measured continuously for 24 hours using a pulse oximeter. The pulse oximeter display will be hidden from clinical staff and alarms will be turned off in order to avoid influencing clinical management. All other clinical care including oxygen titration will be performed as per routine practice. There are no interventions as part of this study. The participant's involvement in the study will end after the 24 hour monitoring period.
Intervention code [1] 317703 0
Not applicable
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 323950 0
Percentage of recording time spent with SpO2 within prescribed target range as measured by the pulse oximeter
Timepoint [1] 323950 0
End of 24 hour recording period
Secondary outcome [1] 383407 0
Percentage of recording time spent with SpO2 <80% as measured by the pulse oximeter
Timepoint [1] 383407 0
End of 24 hour recording period
Secondary outcome [2] 383408 0
Percentage of recording time spent with SpO2 80-84% as measured by the pulse oximeter
Timepoint [2] 383408 0
End of 24 hour recording period
Secondary outcome [3] 383409 0
Percentage of recording time spent with SpO2 84-88% as measured by the pulse oximeter
Timepoint [3] 383409 0
End of 24 hour recording period
Secondary outcome [4] 383410 0
Percentage of recording time spent with SpO2 88-92% as measured by the pulse oximeter
Timepoint [4] 383410 0
End of 24 hour recording period
Secondary outcome [5] 383411 0
Percentage of recording time spent with SpO2 92-96% as measured by the pulse oximeter
Timepoint [5] 383411 0
End of 24 hour recording period
Secondary outcome [6] 383412 0
Percentage of recording time spent with SpO2 96-100% as measured by the pulse oximeter
Timepoint [6] 383412 0
End of 24 hour recording period

Eligibility
Key inclusion criteria
Age greater than or equal to 18 years
Admission for an acute illness
Receiving oxygen therapy
Expected duration of admission >24 hours
Target SpO2 prescribed (must include an upper and lower limit)
Under the care of a General Medicine or Respiratory team
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Suspected or proven infection with SARS-CoV-2 (COVID-19)
Inability to consent
Inability to perform continuous pulse oximetry (vascular compromise, anatomical deformity)

Study design
Purpose
Natural history
Duration
Cross-sectional
Selection
Defined population
Timing
Prospective
Statistical methods / analysis
Data descriptions will include mean and standard deviation (SD) and median and inter-quartile range (IQR) and minimum to maximum.

A review will be performed after the first 25 participants to determine the data distribution. If normality assumptions are not strongly violated, the analysis will be a general linear model (ANCOVA) with predictor variables of clinical interest. A confidence interval for the SD will be estimated using a Chi-square method. If normality assumptions are strongly violated and not improved by a transformation (such as a logarithm transformation), the primary outcome will be the count of measurements in the target range, with total number of measurements as an offset variable. Poisson regression will be used to estimate the relative rate of readings in target range, with the predictor co-variates as outlined. An agreement analysis will also be performed comparing all SpO2 data to SpO2 data with good signal quality for the primary outcome.

For the secondary outcomes, a histogram will be constructed to describe the percentage of time spent within SpO2 thresholds (<80%, 80-84%, 84-88%, 88-92%, 92-96%, 96-100%). Histograms will be constructed for participants with SpO2 target ranges of 88-92% and 92-96%.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
24/07/2020
Actual
Date of last participant enrolment
Anticipated
30/10/2020
Actual
Date of last data collection
Anticipated
1/11/2020
Actual
Sample size
Target
100
Accrual to date
Final
Recruitment outside Australia
Country [1] 22584 0
New Zealand
State/province [1] 22584 0

Funding & Sponsors
Funding source category [1] 305838 0
Other
Name [1] 305838 0
The Medical Research Institute of New Zealand
Country [1] 305838 0
New Zealand
Primary sponsor type
Other
Name
The Medical Research Institute of New Zealand
Address
Level 7, CSB Building
Wellington Hospital
Riddiford St, Newtown
Wellington 6021
New Zealand
Country
New Zealand
Secondary sponsor category [1] 306282 0
None
Name [1] 306282 0
Address [1] 306282 0
Country [1] 306282 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 306102 0
Victoria University of Wellington Human Ethics Committee
Ethics committee address [1] 306102 0
Victoria University of Wellington,
Kelburn Campus,
Wellington, 6012,
New Zealand
Ethics committee country [1] 306102 0
New Zealand
Date submitted for ethics approval [1] 306102 0
05/06/2020
Approval date [1] 306102 0
09/07/2020
Ethics approval number [1] 306102 0
0000028645

Summary
Brief summary
Some people who are unwell in hospital need to be given oxygen. This is done to improve blood oxygen levels and is usually given through a mask or small prongs which sit inside the nostrils.

Research studies have shown that it is very important to give the correct amount oxygen. Blood oxygen levels which are either too high or too low can be harmful. Depending on the particular illness, there is a recommended ‘target range’ for blood oxygen levels.

At the moment, doctors and nurses intermittently turn the amount of oxygen up or down to try and get a patient’s blood oxygen levels in the ‘target range’. This can be difficult to get right because the amount of oxygen a patient needs will change over time.

This purpose of this study is to continuously measure blood oxygen levels using a finger sensor for 24 hours. This will help us find out how much time patients spend with blood oxygen levels in the ‘target range’. This is important to know to help improve the way oxygen is given in hospital.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 102714 0
Dr James Harper
Address 102714 0
Level 7, CSB Building
Wellington Hospital
Riddiford St, Newtown
Wellington 6021
New Zealand
Country 102714 0
New Zealand
Phone 102714 0
+64 048050232
Fax 102714 0
Email 102714 0
james.harper@mrinz.ac.nz
Contact person for public queries
Name 102715 0
Dr James Harper
Address 102715 0
Level 7, CSB Building
Wellington Hospital
Riddiford St, Newtown
Wellington 6021
New Zealand
Country 102715 0
New Zealand
Phone 102715 0
+64 048050232
Fax 102715 0
Email 102715 0
james.harper@mrinz.ac.nz
Contact person for scientific queries
Name 102716 0
Dr James Harper
Address 102716 0
Level 7, CSB Building
Wellington Hospital
Riddiford St, Newtown
Wellington 6021
New Zealand
Country 102716 0
New Zealand
Phone 102716 0
+64 048050232
Fax 102716 0
Email 102716 0
james.harper@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?
Individual participant data that underlie the results reported, after de-identification
When will data be available (start and end dates)?
One year after publication until a minimum of 5 years after publication.
Available to whom?
Researchers who provide a methodologically sound proposal that has been approved by the study steering committee.
Available for what types of analyses?
To achieve the aims outlined in the approved proposal
How or where can data be obtained?
Through a signed data access agreement subject to approval by the Principal Investigator by email to james.harper@mrinz.ac.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
SourceTitleYear of PublicationDOI
EmbaseDetermination of oxygen saturation compared to a prescribed target range using continuous pulse oximetry in acutely unwell medical patients.2021https://dx.doi.org/10.1186/s12890-021-01700-6
N.B. These documents automatically identified may not have been verified by the study sponsor.