Mathematically Arterialised Testing of Hypercapnic Subjects Study

NCT ID: NCT04072848

Last Updated: 2022-09-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

84 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-10-15

Study Completion Date

2021-07-31

Brief Summary

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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.

Detailed Description

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Conditions

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Hypercapnic Respiratory Failure

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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Inclusion Criteria

* Aged 18 years or above.
* Admitted for consideration of home Non Invasive Ventilation.
* Due to undergo arterial blood gas sampling as part of routine clinical care

Exclusion Criteria

* Inability to provide informed consent.
* Clinical necessity to perform blood gas sampling prior to allowing sufficient time for informed consent.
* Inability to obtain reliable SpO2 readings
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Aalborg University

OTHER

Sponsor Role collaborator

Papworth Hospital NHS Foundation Trust

OTHER_GOV

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Michael Davies

Role: PRINCIPAL_INVESTIGATOR

Royal Papworth Hospital

Locations

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Royal Papworth Hospital

Cambridge, Cambridgeshire, United Kingdom

Site Status

Countries

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United Kingdom

References

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Davies MG, Wozniak DR, Quinnell TG, Palas E, George S, Huang Y, Jayasekara R, Stoneman V, Smith IE, Thomsen LP, Rees SE. Comparison of mathematically arterialised venous blood gas sampling with arterial, capillary, and venous sampling in adult patients with hypercapnic respiratory failure: a single-centre longitudinal cohort study. BMJ Open Respir Res. 2023 Jun;10(1):e001537. doi: 10.1136/bmjresp-2022-001537.

Reference Type DERIVED
PMID: 37369550 (View on PubMed)

Other Identifiers

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P02375

Identifier Type: -

Identifier Source: org_study_id

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