Hypercapnic Respiratory Failure
Conditions
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.
Interventions
None listed
Sponsors
Aalborg University
Papworth Hospital NHS Foundation Trust
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| Change in PaCO2 between ABG versus v-TAC versus Capillary Blood Gas (CBG) versus Venous Blood Gas (VBG) | 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 |
| 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 |
Countries
United Kingdom
Outcome results
None listed