Skip to main content
OpenTrials
Completed

NCT Number: NCT04072848

Mathematically Arterialised Testing of Hypercapnic Subjects Study

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Hypercapnic Respiratory Failure Respiration Disorders Respiratory Insufficiency Respiratory Tract Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Royal Papworth Hospital

Cambridge, Cambridgeshire, CB2 0AY, United Kingdom

Who can participate

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Change in blood carbon dioxide level (PaCO2)

    Time frame: Between day 0 and day 1

    Change in PaCO2 between the pre-NIV (non-invasive ventilation) and day 1 NIV samples for ABG (arterial blood gas) versus v-TAC (arterialised venous blood gas)

Secondary outcomes

  1. Change in PaCO2 between ABG versus v-TAC versus Capillary Blood Gas (CBG) versus Venous Blood Gas (VBG)

    Time frame: Between day 0 and day 1

    Change in PaCO2 between ABG versus v-TAC versus Capillary Blood Gas (CBG) versus Venous Blood Gas (VBG) between the pre-NIV and day 1 samples

  2. Change in PaCO2 between ABG versus v-TAC versus Capillary Blood Gas (CBG) versus Venous Blood Gas (VBG)

    Time frame: Between day 0 and through to study completion, up to 3 days

    Change in PaCO2 between ABG versus v-TAC versus Capillary Blood Gas (CBG) versus Venous Blood Gas (VBG) between the pre-NIV and pre-discharge samples

  3. Relative difficult in sampling

    Time frame: Between day 0 and through to study completion, up to 3 days

    Frequency of sampling error rate for ABG versus CBG versus VBG versus V-TAC

  4. Patient experience

    Time frame: Between day 0 and through to study completion, up to 3 days

    Using Numeric Pain Scale where 0 is no pain, 5 is moderate pain and 10 is worst pain possible

  5. Patient preference

    Time frame: Between day 0 and through to study completion, up to 3 days

    Patient preference for method of blood gas sampling will be recorded in medical records

Sponsors and collaborators

Lead sponsor

Papworth Hospital NHS Foundation Trust

Other Gov

Collaborators

  • Aalborg University

Registry information

Official study title

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

Acronym: MATHS

Important dates

Study start
2018
Primary completion
2020
Study completion
2021
First posted
Aug 28, 2019
Registry last updated
Sep 28, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.