Mathematically Arterialised Testing of Hypercapnic Subjects Study
- Conditions
- Hypercapnic Respiratory Failure
- Registration Number
- NCT04072848
- Lead Sponsor
- Papworth Hospital NHS Foundation Trust
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 84
- 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
- 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
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Change in blood carbon dioxide level (PaCO2) 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 Outcome Measures
Name Time Method Change in PaCO2 between ABG versus v-TAC versus Capillary Blood Gas (CBG) versus Venous Blood Gas (VBG) 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
Relative difficult in sampling 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
Patient experience 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
Patient preference 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
Trial Locations
- Locations (1)
Royal Papworth Hospital
🇬🇧Cambridge, Cambridgeshire, United Kingdom