Mathematically Arterialised Testing of Hypercapnic Subjects Study

Hypercapnic Respiratory Failure Clinical Trial

— MATHS  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04072848
• Other study ID #: P02375
• Status: Completed
• Start date: October 15, 2018
• Est. completion date: July 31, 2021

Study information

• Verified date: May 2022
• Source: Papworth Hospital NHS Foundation Trust
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 84
• Est. completion date: July 31, 2021
• Est. primary completion date: October 8, 2020
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Hypercapnia
• Hypercapnic Respiratory Failure
• Respiratory Insufficiency

Locations

Country	Name	City	State
United Kingdom	Royal Papworth Hospital	Cambridge	Cambridgeshire

Sponsors (2)

Lead Sponsor	Collaborator
Papworth Hospital NHS Foundation Trust	Aalborg University

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in blood carbon dioxide level (PaCO2)	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)	Between day 0 and day 1
Secondary	Change in PaCO2 between ABG versus v-TAC versus Capillary Blood Gas (CBG) versus Venous Blood Gas (VBG)	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	Between day 0 and day 1
Secondary	Change in PaCO2 between ABG versus v-TAC versus Capillary Blood Gas (CBG) versus Venous Blood Gas (VBG)	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	Between day 0 and through to study completion, up to 3 days
Secondary	Relative difficult in sampling	Frequency of sampling error rate for ABG versus CBG versus VBG versus V-TAC	Between day 0 and through to study completion, up to 3 days
Secondary	Patient experience	Using Numeric Pain Scale where 0 is no pain, 5 is moderate pain and 10 is worst pain possible	Between day 0 and through to study completion, up to 3 days
Secondary	Patient preference	Patient preference for method of blood gas sampling will be recorded in medical records	Between day 0 and through to study completion, up to 3 days