Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12615001154594
Ethics application status
Approved
Date submitted
15/10/2015
Date registered
29/10/2015
Date last updated
30/11/2015
Type of registration
Prospectively registered

Titles & IDs
Public title
Comparison of two techniques for measuring carbon dioxide and oxygen levels in patients requiring arterial blood gas measurement.
Scientific title
In patients requiring arterial blood gas (ABG) measurements, how do readings from a transcutaneous monitoring device for carbon dioxide and oxygen saturations compare with values from ABG samples?
Secondary ID [1] 287417 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Respiratory Health 296122 0
Arterial blood gas analysis 296584 0
Condition category
Condition code
Respiratory 296385 296385 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
Eligible and willing participants that are due to have arterial blood gas (ABG) measurements as part of their standard care will have transcutaneous monitors (either one or two SenTec monitoring devices) attached to their earlobe(s). Two separate SenTec devices are being assessed. Both can be tested in each participant (one per earlobe) or one per participant (one device tested on one earlobe). This will be determined by availability of devices (for example, if one device is being used in a separate study and unavailable at the time of recruitment, only one device will be assessed).

A period of at least 30 minutes* will elapse to allow the device(s) to stabilise before the planned ABG is obtained – either by clinical staff or a study investigator. Readings on the transcutaneous monitors will be recorded at the time blood enters the collection vial and compared to analysed results from the ABG.

*time may need to be extended if readings not stable by 30 minutes
Intervention code [1] 292768 0
Not applicable
Comparator / control treatment
Arterial Blood Gas (ABG)
Control group
Active

Outcomes
Primary outcome [1] 296030 0
PtCO2 (transcutaneous carbon dioxide levels) measured on the SenTec device at the same time an arterial blood gas (ABG) is performed.
Timepoint [1] 296030 0
When blood enters the collection vial when obtaining an ABG.
Primary outcome [2] 296151 0
PaCO2 (arterial carbon dioxide levels) measured by ABG while the SenTec device is in place.
Timepoint [2] 296151 0
Taken at the time of the clinically indicated ABG.
Secondary outcome [1] 317286 0
SpO2 (oxygen saturations measured transcutaneously) on the SenTec device at the same time an arterial blood gas (ABG) is performed.
Timepoint [1] 317286 0
When blood enters the collection vial when obtaining an ABG.
Secondary outcome [2] 317287 0
SaO2 (oxygen saturations measured by ABG) while the SenTec device is in place.
Timepoint [2] 317287 0
Taken at the time of the clinically indicated ABG.
Secondary outcome [3] 317621 0
Proportion of patients in whom transcutaneous data could not be obtained due to display warnings regarding poor reading/signal quality on the SenTec device.

Timepoint [3] 317621 0
During monitoring time.
Secondary outcome [4] 318208 0
Incidence of overshoot* (PtCO2) on the SenTec device after sensor application.

*'Overshoot' refers to a situation whereby the device initially over-estimates the carbon dioxide (PtCO2) levels and takes longer to reach a stable state/baseline.
Timepoint [4] 318208 0
Between t=0 and t=30 minutes after SenTec sensor application

Eligibility
Key inclusion criteria
Patients requiring an Arterial Blood Gas (ABG) measurement as part of their clinical care at: Wellington Regional Hospital in New Zealand, either in the outpatient department or on the wards.
Minimum age
16 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
(i). Diagnosis of sickle cell anaemia, methaemoglobinaemia, or carbon monoxide (CO) poisoning (factors known to affect oxygen saturation recordings).

(ii). Patients previously recruited to the study with paired transcutaneous and arterial values successfully recorded on the same device.

(iii). Age under 16 years.

(iv). Poor reading/signal quality from participant’s earlobe(s) as per display warnings on the transcutaneous device.

(v). Any other condition which, at the investigator’s discretion, is believed may present a safety risk or impact upon the feasibility of the study or the interpretation of the study results.

Study design
Purpose
Duration
Selection
Timing
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
9/11/2015
Actual
17/11/2015
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
16
Accrual to date
Final
Recruitment outside Australia
Country [1] 7142 0
New Zealand
State/province [1] 7142 0
Wellington

Funding & Sponsors
Funding source category [1] 291985 0
Other
Name [1] 291985 0
Medical Research Institute of New Zealand
Country [1] 291985 0
New Zealand
Primary sponsor type
Other
Name
Medical Research Institute of New Zealand
Address
Medical research Institute of New Zealand
Level 7, CSB
Wellington Regional Hospital
Riddiford Street
Newtown
Wellington
6021
Country
New Zealand
Secondary sponsor category [1] 290650 0
None
Name [1] 290650 0
Address [1] 290650 0
Country [1] 290650 0
Other collaborator category [1] 278611 0
Individual
Name [1] 278611 0
Janine Pilcher
Address [1] 278611 0
Medical research Institute of New Zealand
Level 7, CSB
Wellington Regional Hospital
Riddiford Street
Newtown
Wellington
6021
Country [1] 278611 0
New Zealand
Other collaborator category [2] 278612 0
Individual
Name [2] 278612 0
George Bardsley
Address [2] 278612 0
Medical research Institute of New Zealand
Level 7, CSB
Wellington Regional Hospital
Riddiford Street
Newtown
Wellington
6021
Country [2] 278612 0
New Zealand
Other collaborator category [3] 278613 0
Individual
Name [3] 278613 0
Steve McKinstry
Address [3] 278613 0
Medical research Institute of New Zealand
Level 7, CSB
Wellington Regional Hospital
Riddiford Street
Newtown
Wellington
6021
Country [3] 278613 0
New Zealand

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 293476 0
Northern B Health and Disability Ethics Committee
Ethics committee address [1] 293476 0
Health and Disability Ethics Committee
Ministry of Health
C/- MEDSAFE, Level 6, Deloitte House
10 Brandon Street
PO BOX 5013
Wellington
6011
Ethics committee country [1] 293476 0
New Zealand
Date submitted for ethics approval [1] 293476 0
31/07/2015
Approval date [1] 293476 0
28/08/2015
Ethics approval number [1] 293476 0
15/STH/121

Summary
Brief summary
The Arterial Blood Gas (ABG) is the gold standard measurement to estimate oxygen saturations and carbon dioxide levels in the bloodstream.

Transcutaneous monitoring of carbon dioxide and oxygen saturations has the advantage of being easily measured using a small clip, usually placed on the earlobe. Unlike an ABG measurement, it allows continuous monitoring of carbon dioxide and oxygen levels, is painless, and does not have the risk of causing distal ischemia.

The SenTec transcutaneous monitors have been used in several of our studies investigating the effects of oxygen therapy on blood carbon dioxide and oxygen levels. While the SenTec devices have been validated previously in one study, the devices need to be validated in the setting and under the standard operating procedures (SOPs) that are used in Medical Research Institute of New Zealand (MRINZ) trials.

Our aim is to recruit patients (inpatients or outpatients) who are due to receive an ABG as part of their clinical management at Wellington Regional Hospital. When the ABG sample is taken the study investigator will record the carbon dioxide and oxygen saturation levels displayed by the transcutaneous monitor(s). These will then be compared to the ABG results.
Trial website
Trial related presentations / publications
Public notes
Please note that 16 is the minimum number of participants we plan to recruit. We are testing two SenTec devices, and for each device, there must be 16 measurements made. These can be individually paired (one device per participant) or paired simultaneously (both devices on one participant at the same time - one on each earlobe). Therefore, the maximum number of participants that may be recruited should not exceed 32, if only one device were attached to each individual participant recruited.

Contacts
Principal investigator
Name 60074 0
Dr George Bardsley
Address 60074 0
MRINZ
Level 7, CSB
Wellington Regional Hospital
Riddiford St.
Newtown
Wellington 6021
Country 60074 0
New Zealand
Phone 60074 0
+64 4 805 0262
Fax 60074 0
Email 60074 0
[email protected]
Contact person for public queries
Name 60075 0
Dr George Bardsley
Address 60075 0
MRINZ
Level 7, CSB
Wellington Regional Hospital
Riddiford St.
Newtown
Wellington 6021
Country 60075 0
New Zealand
Phone 60075 0
+64 4 805 0147
Fax 60075 0
Email 60075 0
[email protected]
Contact person for scientific queries
Name 60076 0
Dr George Bardsley
Address 60076 0
MRINZ
Level 7, CSB
Wellington Regional Hospital
Riddiford St.
Newtown
Wellington 6021
Country 60076 0
New Zealand
Phone 60076 0
+64 4 805 0147
Fax 60076 0
Email 60076 0
[email protected]

No information has been provided regarding IPD availability


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No Supporting Document Provided



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