Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12619001431112
Ethics application status
Approved
Date submitted
19/09/2019
Date registered
16/10/2019
Date last updated
11/01/2023
Date data sharing statement initially provided
16/10/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
A prospective, observational study investigating the level of agreement between transcutaneous and invasive carbon dioxide measurements in critically ill emergency department patients
Scientific title
A prospective, observational study investigating the level of agreement between transcutaneous and invasive carbon dioxide measurements in critically ill emergency department patients
Secondary ID [1] 299307 0
Nil known
Universal Trial Number (UTN)
U1111-1240-3640
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Critical illness 314436 0
Condition category
Condition code
Emergency medicine 312778 312778 0 0
Resuscitation

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
This study is comparing measurements of carbon dioxide levels in arterial blood (standard care for critically unwell patients) with measurements of carbon dioxide taken from a transcutaneous (skin surface) probe. Our study will look at the level of agreement between these two measurement methods to examine whether the skin probe is adequate to monitor carbon dioxide in the emergency department setting. If shown to be adequate, it could spare patients a painful procedure (arterial cannulation) which is currently required as the standard of care.

Our intervention is the use of the Sentec Digital Monitor System to perform carbon dioxide level measurements at 4 time intervals for the study participants. Emergency department nursing staff will use the Sentec Digital Monitor System's sensor which is clipped to the patient's ear to perform transcutaneous measurement of carbon dioxide levels at 0mins, 30mins, 60mins and 90mins post enrolment in the emergency department resuscitation area.
Intervention code [1] 315576 0
Diagnosis / Prognosis
Comparator / control treatment
Arterial blood carbon dioxide measurement taken from an arterial catheter placed in the emergency department by a senior member of the emergency medical team, standard care for such patients. Emergency department nursing staff will take 4 measurements at matched time intervals to the transcutaneous carbon dioxide measurements, at 0mins, 30mins, 60mins and 90mins post enrolment in the emergency department resuscitation area.
Control group
Active

Outcomes
Primary outcome [1] 321397 0
Transcutaneous Carbon Dioxide reading at the specified timepoints measured by a skin detector clipped to the earlobe of the patient using the Sentec Digital Monitor System.
Timepoint [1] 321397 0
0mins, 30mins, 60mins and 90mins post enrolment.
Primary outcome [2] 321535 0
Arterial Carbon Dioxide reading at the specified timepoints, obtained on a sample taken from an arterial catheter (as part of standard care) and measured using a Radiometer ABL800 blood gas analyser.
Timepoint [2] 321535 0
0mins, 30mins, 60mins and 90mins post enrolment.
Secondary outcome [1] 374871 0
Presence of haemodynamic instability based on clinical examination (defined as systolic blood pressure below 90mmHg, Mean Arterial Blood Pressure below 60mmHg, or requirement for vasopressor support).
Timepoint [1] 374871 0
Once diagnosis becomes apparent, recorded at the time of assessment and treatment between 0mins and 90mins post enrolment.
Secondary outcome [2] 375552 0
Diagnosis of exacerbation of chronic obstructive pulmonary disease, based on bedside clinical assessment.
Timepoint [2] 375552 0
Once diagnosis becomes apparent, recorded at the time of assessment and treatment between 0mins and 90mins post enrolment.

Eligibility
Key inclusion criteria
Emergency department patient
Patient requiring hospital admission
Adult > 18 years of age
Arterial catheter required for ongoing care
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Children (<18 years)
Patients not requiring arterial line

Study design
Purpose
Natural history
Duration
Cross-sectional
Selection
Defined population
Timing
Prospective
Statistical methods / analysis
The estimation of a required study sample size of 42 patients is based upon power calculations guided by existing research literature results (90% power, alpha = 0.05, Bias 1.7 and SD 3.9), performed with the help of a statistician.

Our primary outcome of interest will be PaCO2 and PtcCO2 agreement expressed as mean difference. The acceptable threshold of agreement has been regarded as +/- 4 mmHg in previous literature, and we acknowledge that while a closer degree of agreement would be ideal, this standard would still be clinically relevant. The degree of agreement between our intervention and comparator will be analysed using a Bland-Altman analysis, to alpha value of 0.05 (95% confidence interval).

The study's secondary outcomes are subgroup analyses of the level of agreement between transcutaneous and arterial carbon dioxide readings in those presenting with either an exacerbation of chronic obstructive pulmonary disease or haemodynamic instability, also using a Bland-Altman analysis, to alpha value of 0.05 (95% confidence interval).

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/07/2020
Actual
22/06/2020
Date of last participant enrolment
Anticipated
Actual
25/04/2021
Date of last data collection
Anticipated
Actual
30/06/2021
Sample size
Target
42
Accrual to date
Final
42
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 14808 0
Liverpool Hospital - Liverpool
Recruitment postcode(s) [1] 28058 0
2170 - Liverpool

Funding & Sponsors
Funding source category [1] 303828 0
Hospital
Name [1] 303828 0
Liverpool Hospital Emergency Department
Country [1] 303828 0
Australia
Primary sponsor type
Government body
Name
South Western Sydney Local Health District
Address
Liverpool Hospital
Elizabeth Street
Liverpool, NSW 2170
Country
Australia
Secondary sponsor category [1] 303954 0
None
Name [1] 303954 0
Address [1] 303954 0
Country [1] 303954 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 304342 0
South West Sydney Local Health District Human research Ethics Committee
Ethics committee address [1] 304342 0
Research Directorate
Locked Bag 7103
LIVERPOOL BC NSW 1871
Ethics committee country [1] 304342 0
Australia
Date submitted for ethics approval [1] 304342 0
15/10/2019
Approval date [1] 304342 0
03/03/2020
Ethics approval number [1] 304342 0
2019/ETH12736

Summary
Brief summary
This is an observational study of 42 patients comparing measurements of carbon dioxide levels in their arterial blood (standard care for critically unwell patients) with measurements of carbon dioxide taken from a transcutaneous (skin) probe. Our study will look at the level of agreement between these two measurements with the implication that if there is good agreement, a much less invasive (less painful) transcutaneous measurement may be adequate to monitor carbon dioxide levels.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 96614 0
Dr Ian Ferguson
Address 96614 0
Liverpool Emergency Department,
Liverpool Hospital
Elizabeth Street
Liverpool, NSW 2170
Country 96614 0
Australia
Phone 96614 0
+61 02 87383000
Fax 96614 0
Email 96614 0
[email protected]
Contact person for public queries
Name 96615 0
Scott Farenden
Address 96615 0
Liverpool Emergency Department,
Liverpool Hospital
Elizabeth Street
Liverpool, NSW 2170
Country 96615 0
Australia
Phone 96615 0
+61 02 87383000
Fax 96615 0
Email 96615 0
[email protected]
Contact person for scientific queries
Name 96616 0
Scott Farenden
Address 96616 0
Liverpool Emergency Department,
Liverpool Hospital
Elizabeth Street
Liverpool, NSW 2170
Country 96616 0
Australia
Phone 96616 0
+61 02 87383000
Fax 96616 0
Email 96616 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
Not necessary for the validity of the trial to release individual participant data. To ensure patient confidentiality IPD will not be shared.


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
4870Study protocol    378389-(Uploaded-19-09-2019-20-50-12)-Study-related document.docx



Results publications and other study-related documents

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