Mathematically Arterialised Testing of Hypercapnic Subjects Study

NCT04072848 | Completed

• 1 other identifier: P02375
• Study Type: observational
• Target: 84
• Locations: 1 country
• Sites: 1

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.

Conditions

Hypercapnic Respiratory Failure

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• 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 day 0 and through to study completion, up to 3 days

• Relative difficult in sampling

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

• Patient experience

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

• Patient preference

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adult patients with suspected chronic hypercapnic respiratory failure admitted as part of routine clinical care for consideration of home NIV.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Papworth Hospital NHS Foundation Trust: lead
• Aalborg University: collaborator

Study Sites (1)

Royal Papworth Hospital

Cambridge, Cambridgeshire, CB2 0AY, United Kingdom

Location

Related Publications (1)

• Davies MG, Wozniak DR, Quinnell TG, Palas E, George S, Huang Y, Jayasekara R, Stoneman V, Smith IE, Thomsen LP, Rees SE. Comparison of mathematically arterialised venous blood gas sampling with arterial, capillary, and venous sampling in adult patients with hypercapnic respiratory failure: a single-centre longitudinal cohort study. BMJ Open Respir Res. 2023 Jun;10(1):e001537. doi: 10.1136/bmjresp-2022-001537.

  PMID: 37369550 DERIVED

MeSH Terms

Conditions

Respiratory Insufficiency

Condition Hierarchy (Ancestors)

Respiration Disorders; Respiratory Tract Diseases

Study Officials

• Michael Davies

  Royal Papworth Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 23, 2019
• First Posted: August 28, 2019
• Study Start: October 15, 2018
• Primary Completion: October 8, 2020
• Study Completion: July 31, 2021
• Last Updated: September 28, 2022

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)