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Trial record 74 of 667 for:    CARBON DIOXIDE AND arterial

Mathematically Arterialised Testing of Hypercapnic Subjects Study (MATHS)

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ClinicalTrials.gov Identifier: NCT04072848
Recruitment Status : Recruiting
First Posted : August 28, 2019
Last Update Posted : August 28, 2019
Sponsor:
Collaborator:
Aalborg University
Information provided by (Responsible Party):
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.

Condition or disease
Hypercapnic Respiratory Failure

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Study Type : Observational
Estimated Enrollment : 50 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: A Prospective Observational Cohort Study to Investigate the Physiological Agreement Between Arterial Sampling (the Reference Method) and Mathematically Arterialised Venous Blood
Actual Study Start Date : October 15, 2018
Estimated Primary Completion Date : March 2020
Estimated Study Completion Date : June 2020



Primary Outcome Measures :
  1. 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)


Secondary Outcome Measures :
  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 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

  2. 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 ]
    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

  3. Relative difficult in sampling [ Time Frame: 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

  4. Patient experience [ Time Frame: 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

  5. Patient preference [ Time Frame: 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



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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.
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04072848


Contacts
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Contact: Michael Davies +44(0)1480364189 michael.davies@nhs.net
Contact: Victoria Stoneman +44(0)1223639865 victoria.stoneman@nhs.net

Locations
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United Kingdom
Royal Papworth Hospital Recruiting
Papworth Everard, Cambridgeshire, United Kingdom, CB23 3RE
Contact: Victoria Stoneman, PhD    01223639865    victoria.stoneman@nhs.net   
Contact: Jennifer Gray    01223639717    jennifer.gray13@nhs.net   
Sponsors and Collaborators
Papworth Hospital NHS Foundation Trust
Aalborg University
Investigators
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Principal Investigator: Michael Davies Royal Papworth Hospital

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Responsible Party: Papworth Hospital NHS Foundation Trust
ClinicalTrials.gov Identifier: NCT04072848     History of Changes
Other Study ID Numbers: P02375
First Posted: August 28, 2019    Key Record Dates
Last Update Posted: August 28, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Respiratory Insufficiency
Hypercapnia
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Signs and Symptoms