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Trial registered on ANZCTR


Registration number
ACTRN12618000816257
Ethics application status
Approved
Date submitted
18/04/2018
Date registered
11/05/2018
Date last updated
11/05/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
Establishing a library of physiological waveforms in anaesthesia and intensive care
Scientific title
An observational study of physiological waveforms during anaesthesia and intensive care management.
Secondary ID [1] 294607 0
Nil known
Universal Trial Number (UTN)
U1111-1212-4003
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Patients having physiological monitoring during anaesthesia and intensive care 307440 0
Condition category
Condition code
Anaesthesiology 306527 306527 0 0
Other anaesthesiology

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Physiological waveforms will be recorded during anaesthesia and intensive care management including ECG, blood pressure, pulse oximetry, BIS, airway pressure and capnography. These will be recorded during care [up to 4 hours]. After deidentification they will be archived for future testing of signal processing algorithms.
Intervention code [1] 300912 0
Not applicable
Comparator / control treatment
No control group.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 305533 0
Set of recordings of ECG waveforms. [Observational study]
Timepoint [1] 305533 0
During single acute care episode
Primary outcome [2] 305601 0
Set of digital recordings of blood pressure waveforms at .100Hz. for future exploratory algorithm development
Timepoint [2] 305601 0
During a single acute care episode.
Primary outcome [3] 305602 0
Set of recordings of digital pulse oximeter plethysmograph waveforms at .100Hz. for future exploratory algorithm development.
Timepoint [3] 305602 0
During a single acute care episode.
Secondary outcome [1] 345643 0
Set of recordings of digital capnograph waveforms. for future exploratory algorithm development. [Primary Outcome]
Timepoint [1] 345643 0
During a single acute care episode.
Secondary outcome [2] 345644 0
Set of recordings of digital Bispectral index [BIS] waveforms at .100Hz. for future exploratory algorithm development. The BIS waveform is a directly recorded electroencephalogram from a set of dermal electrodes on the forehead. [Primary Outcome]
Timepoint [2] 345644 0
During a single acute care episode.
Secondary outcome [3] 345783 0
Set of recordings of digital airway pressure waveforms from a continuous pressure sensor signal measured in the airway circuit near the patient. In addition to peak and trough pressures inspiratory and expiratory intervals will be explored for future algorithm development. [Primary Outcome]
Timepoint [3] 345783 0
During a single acute care episode

Eligibility
Key inclusion criteria
Patients connected to a patient physiological monitor during anaesthesia or intensive care management
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
age less than 18 years.

Study design
Purpose
Natural history
Duration
Cross-sectional
Selection
Convenience sample
Timing
Prospective
Statistical methods / analysis
This is an observational single group study aiming to develop a library of physiological waveforms. Analysis will be by testing a variety of signal processing algorithms rather than testing hypotheses or describing populations. Collection of data will occur by convenience until the maximum number is achieved. A power analysis is not appropriate.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
14/05/2018
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
200
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 10721 0
Shoalhaven Hospital - Nowra
Recruitment hospital [2] 10722 0
St George Hospital - Kogarah
Recruitment postcode(s) [1] 22442 0
2541 - Nowra
Recruitment postcode(s) [2] 22443 0
2217 - Kogarah

Funding & Sponsors
Funding source category [1] 299225 0
Hospital
Name [1] 299225 0
St. George Public Hospial
Country [1] 299225 0
Australia
Primary sponsor type
Hospital
Name
St. George Hospital
Address
Department of Anaesthesia
St. George Hospital
Gray St. Kogarah
NSW 2217
Country
Australia
Secondary sponsor category [1] 298507 0
None
Name [1] 298507 0
Address [1] 298507 0
Country [1] 298507 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 300149 0
South Eastern Sydney LHD Research Ethics Committee
Ethics committee address [1] 300149 0
Research Support Office
G71, East Wing
Edmund Blacket Building
Prince of Wales Hospital
Randwick NSW 2031
Ethics committee country [1] 300149 0
Australia
Date submitted for ethics approval [1] 300149 0
24/04/2018
Approval date [1] 300149 0
09/05/2018
Ethics approval number [1] 300149 0
18/098 (LNR/18/POWH/216)

Summary
Brief summary
During anaesthesia and intensive care multiple physiological measurements are made such as electrocardiogram, arterial blood pressure, pulse oximetry, capnography, lung inflation flows and pressures and processed EEG. The increasing availability of sophisticated signal processing techniques and the computing power to undertake them means that novel indexes can be developed to enhance the effectiveness of the monitors and promote deeper insights into patient wellbeing..

This study will use an observational, opportunisic methodology to assemble a set of deidentified waveforms during anaesthesia and intensive care management. This library will then be available for ad-hoc testing of various signal processing strategies.
Trial website
None
Trial related presentations / publications
None
Public notes

Contacts
Principal investigator
Name 82706 0
A/Prof Richard Morris
Address 82706 0
Department of Anaesthesia
St. George Hospital
Gray St. Kogarah
NSW 2217
Country 82706 0
Australia
Phone 82706 0
+61 2 91131111
Fax 82706 0
Email 82706 0
[email protected]
Contact person for public queries
Name 82707 0
Richard Morris
Address 82707 0
Department of Anaesthesia
St. George Hospital
Gray St. Kogarah
NSW 2217
Country 82707 0
Australia
Phone 82707 0
+61 2 91131111
Fax 82707 0
Email 82707 0
[email protected]
Contact person for scientific queries
Name 82708 0
Richard Morris
Address 82708 0
Department of Anaesthesia
St. George Hospital
Gray St. Kogarah
NSW 2217
Country 82708 0
Australia
Phone 82708 0
+61 2 91131111
Fax 82708 0
Email 82708 0
[email protected]

No information has been provided regarding IPD availability


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.