Hypercapnic Respiratory FailureMATHSNCT04072848
Mathematically Arterialised Testing of Hypercapnic Subjects Study
An observational study of Hypercapnic Respiratory Failure, run by Papworth Hospital NHS Foundation Trust at 1 site in United Kingdom.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hypercapnic Respiratory Failure
- How many people
- 84 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 15 Oct 2018to 31 Jul 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Adult, Older adult
Study population: Adult patients with suspected chronic hypercapnic respiratory failure admitted as part of routine clinical care for consideration of home NIV.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Royal Papworth Hospital
Cambridge, Cambridgeshire, CB2 0AY
About this study
Official title: A Prospective Observational Cohort Study to Investigate the Physiological Agreement Between Arterial Sampling (the Reference Method) and Mathematically Arterialised Venous Blood
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
- Medical subject headings
- Respiratory Insufficiency
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 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)
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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: Between day 0 and through to study completion, up to 3 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2019
- Study start15 Oct 2018
- Primary completion8 Oct 2020
- Study completion31 Jul 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Hypercapnic Respiratory FailureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 84 participants (actual)
Sponsor and investigators
- Lead sponsor
- Papworth Hospital NHS Foundation Trust
- Sponsor type
- Other government
- Collaborators
- Aalborg University
- Responsible party
- Sponsor
- Investigators
- Michael Davies, Principal investigator, Royal Papworth Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04072848
- Sponsor's protocol ID
- P02375
- Acronym
- MATHS
- Status last verified
- May 2022
- First submitted
- 23 Jan 2019
- Last updated
- 28 Sep 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 37369550
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Observational Cohort Study to Investigate the Physiological Agreement Between Arterial Sampling (the Reference Method) and Mathematically Arterialised Venous Blood
- ClinicalTrials.gov ID
- NCT04072848
- Acronym / sponsor ID
- MATHS / P02375
- Conditions
- Hypercapnic Respiratory Failure
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 84 participants (actual)
- Lead sponsor
- Papworth Hospital NHS Foundation TrustOther government
- Collaborators
- Aalborg University
- Study start
- 15 Oct 2018 (actual)
- Primary completion
- 8 Oct 2020 (actual)
- Study completion
- 31 Jul 2021 (actual)
- First posted
- 28 Aug 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Adult patients with suspected chronic hypercapnic respiratory failure admitted as part of routine clinical care for consideration of home NIV.
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Change in blood carbon dioxide level (PaCO2)
Time frame: 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)
5 secondary outcomes
Change in PaCO2 between ABG versus v-TAC versus Capillary Blood Gas (CBG) versus Venous Blood Gas (VBG)
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)
Time frame: Between day 0 and through to study completion, up to 3 days
Relative difficult in sampling
Time frame: Between day 0 and through to study completion, up to 3 days
Patient experience
Time frame: Between day 0 and through to study completion, up to 3 days
Patient preference
Time frame: Between day 0 and through to study completion, up to 3 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Sep 2022.
- Derived from this study: PubMed 37369550Davies 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michael Davies principal investigator
Royal Papworth Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hypercapnic Respiratory Failure, run by Papworth Hospital NHS Foundation Trust at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in blood carbon dioxide level (PaCO2) (time frame: Between day 0 and day 1). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04072848, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Sep 2022.