Mathematically Arterialised Testing of Hypercapnic Subjects Study

Papworth Hospital NHS Foundation Trust84 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Hypercapnic Respiratory Failure

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Outcomes

Primary Outcomes

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)

Time frame: Between day 0 and day 1

Secondary Outcomes

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

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)

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

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

Relative difficult in sampling

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

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

Patient experience

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

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

Patient preference

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

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