RecruitingACTRN12615001154594

Comparison of two techniques for measuring carbon dioxide and oxygen levels in patients requiring arterial blood gas measurement.

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?


Sponsor

Medical Research Institute of New Zealand

Enrollment

16 participants

Start Date

Nov 17, 2015

Study Type

Observational

Conditions

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.


Eligibility

Sex: Both males and femalesMin Age: 16 Yearss

Plain Language Summary

Simplified for easier understanding

This study is checking how well a small clip placed on the earlobe can measure oxygen and carbon dioxide levels in the blood, compared to the traditional method of taking a blood sample from an artery (arterial blood gas test). The clip-on device is painless and continuous. Researchers want to confirm it gives accurate enough results to use in future studies. You may be eligible if: - You are 16 years or older - You are a patient at Wellington Regional Hospital who needs an arterial blood gas test as part of your regular medical care You may NOT be eligible if: - You have sickle cell anemia, methemoglobinemia, or carbon monoxide poisoning - You have previously been enrolled in this same study - You are under 16 years old - The earlobe clip gives a poor reading or signal quality Talk to your doctor about whether this trial might be right for you.

This is a simplified summary. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

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 devic

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


Locations(1)

Wellington, New Zealand

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ACTRN12615001154594