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CompletedNCT04072848

Mathematically Arterialised Testing of Hypercapnic Subjects Study

A Prospective Observational Cohort Study to Investigate the Physiological Agreement Between Arterial Sampling (the Reference Method) and Mathematically Arterialised Venous Blood

Status
Completed
Phase
Study type
Observational
Enrollment
84 (actual)
Sponsor
Papworth Hospital NHS Foundation Trust · Other Government
Sex
All
Age
18 Years
Healthy volunteers

Summary

Prospective observational cohort study of patients admitted to hospital with suspected hypercapnic respiratory failure and requiring treatment with non-invasive ventilation (NIV) as part of standard, routine management. Contemporaneous blood gas samples will be obtained via arterial, capillary, and venous methods. The venous samples will undergo mathematical arterialisation via the v-TAC system. In line with standard medical care, arterial samples will be obtained before starting NIV and at two set points afterwards (day 1 post-NIV, and pre-discharge). Pre-existing clinical thresholds will be used to assess the reliability of v-TAC against ABG, the existing gold standard and will conduct a retrospective model of decision-making once the blood sampling component of the study is concluded.

Conditions

Timeline

Start date
2018-10-15
Primary completion
2020-10-08
Completion
2021-07-31
First posted
2019-08-28
Last updated
2022-09-28

Locations

1 site across 1 country: United Kingdom

Source: ClinicalTrials.gov record NCT04072848. Inclusion in this directory is not an endorsement.

Mathematically Arterialised Testing of Hypercapnic Subjects Study (NCT04072848) · Clinical Trials Directory