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Technical Study: Analytical Performance Evaluation of cobas pulse CIM RD005298

Technical Study: Analytical Performance Evaluation of cobas pulse CIM RD005298 - Cobas pulse performance in practice

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
NL-OMON
Registry ID
NL-OMON49944
Enrollment
600
Registered
2020-08-27
Start date
2021-01-21
Completion date
Unknown
Last updated
2024-04-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

geen speciale klassen, patienten met en zonder diabetes diabetes or patient with dysglycemia

Interventions

None listed

Sponsors

Roche Diagnostics Operations, Inc
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

Inclusion criteria: Adult. Signed informed consent (for critically ill, before admittance to the ICU after scheduled operation). Diabetic and non-diabetic.

Exclusion criteria

Exclusion criteria: Minor (

Design outcomes

Primary

MeasureTime frame
The primary research parameter is the glucose concentration. To assess whether the Cobas Pulse shows sufficient measuring accuracy when used in practice, the following assessment criteria are used: 1. Precision: - samples with a glucose concentration

Secondary

MeasureTime frame
In order to detect and explain possible interference, the hematocrit, the sodium concentration and the partial oxygen pressure (pO2) are determined in addition to the glucose measurement per patient (on the iStat from material of the same sample). As additional information, the medication used and, if established, the diagnosis is also sent.

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)