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ReAcT CO2: A Study to Assess TcCO2 to Guide Acute NIV (ReAcTCO2)

Primary Purpose

Acute Hypercapnic Respiratory Failure

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Trancutaneous CO2 monitoring (using TCM5 device)
Arterial Blood Gas (ABG) sampling
Sponsored by
Nottingham University Hospitals NHS Trust
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Acute Hypercapnic Respiratory Failure

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Patients aged18 years and over with hypercapnia, requiring acute NIV and who are admitted to the Emergency Department or Medical HDU and, who need arterial blood sampling for clinical reasons. Recruited ideally within 4 hours (but no later than 8 hours) of initiation of acute NIV in hospital. Exclusion Criteria: Reduced level of consciousness or agitation. Metabolic or mixed acidosis, serum bicarbonate < 24 mmol/L. Haemodynamic instability or reduced skin perfusion. Patients requiring more than 6litres/min (ormorethan60%) inspired oxygen through ventilator to maintain SpO2 of 88-92%. Need for multi-organ support e.g. inotropes or vasopressors or renal replacement therapy Arterial pH equal or less than 7.1 or carbon dioxide levels >15kPa as they are at risk of NIV failure and likely to require mechanical ventilation. Participating in any other interventional study

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Experimental

    Arm Label

    Arterial Blood Gas (ABG) arm - Control arm

    transcutaneous CO2 arm

    Arm Description

    Patients in this arm will undergo arterial blood gas sampling to monitor CO2 as per the British Thoracic Society guidance which is standard practice.

    Patients in this arm will undergo transcutaneous monitoring to monitor CO2. This will be the experimental arm.

    Outcomes

    Primary Outcome Measures

    Average number of arterial blood gases per participant over the study period
    the total (Scheduled and unscheduled) arterial blood samples over 72 hours per participant in each group .
    number of unscheduled arterial blood sample in each group
    arterial blood sampling needed for clinical deterioration or due to unreliability of transcutaneous CO2 monitoring for each patient
    number of instances where transcutaneous monitoring was unreliable and arterial blood gas sampling was needed.
    Clinicians will complete questionnaires regarding the need for unscheduled arterial blood samples and changes in management due to these incidences of arterial blood sampling in the transcutaneous monitoring group.

    Secondary Outcome Measures

    Pain and any discomfort from arterial blood sampling and transcutaneous monitoring using a visual analogue scale from 0 to 10 with 0 being no pain and 10 being the worst pain they have ever experienced
    Pain and any discomfort (such as skin burns, blisters, erythema, bruising or restriction of physical activity) from arterial blood sampling and transcutaneous monitoring
    Proportion of patients admitted with acute hypercapnic respiratory failure that are suitable and agree to participate in the study over one year (to help guide future studies).
    Suitability and feasibility
    Proportion of patients who achieve 50% drop in carbon dioxide in 12 hours and those who achieve carbon dioxide level of 7 kPa or less in 72 hours in each group.
    Proportion of patients who achieve 50% drop in carbon dioxide in 12 hours and those who achieve carbon dioxide level of 7 kPa or less in 72 hours in each group.
    Proportion of patients who need further changes to ventilator settings beyond 4 hours and 24 hours
    How quickly can we optimise NIV settings
    Proportion of patients with deterioration in CO2 at 4 and 24 hours after NIV initiation
    Can TcCO2 identify deteriorating patients quicker
    Proportion of patients who get better and are discharged and proportion that fail to respond and either need mechanical ventilation / progress to palliative care.
    Proportion of patients who get better and are discharged and proportion that fail to respond and either need mechanical ventilation / progress to palliative care.
    Transcutaneous arm only - agreement between arterial and transcutaneous readings:
    a) absolute CO2 values obtained within 30 minutes of each other will be tested using Bland Altman plot; b) trend between serial ABG CO2 values and transcutaneous CO2 readings when ABGs performed (scheduled and unscheduled ABG will be assessed separately).
    Discrete choice: what method would patients prefer for monitoring during similar future illness requiring NIV?
    Do patients prefer one method of monitoring over the other. This is reasonable to ask all those randomized to TcCO2 as they will experience both ABG and TcCO2
    Clinician Preference questionnaire: whether they prefer ABG versus transcutaneous CO2 monitoring
    Taking into consideration time and difficulty, plus certainty of implementing changes to NIV settings and weaning, with respect to modality of carbon dioxide monitoring.
    Time needed to wean off NIV in each group i.e. time from documented clinician decision to wean, until time of cessation of NIV.
    This would help assess whether transcutaneous CO2 monitoring allows for quicker weaning from NIV.
    Basic Health economics data will be gathered to assess whether transcutaneous monitoring is a cost effective way compared to arterial blood gas sampling.
    Cost effectiveness of the two methods to monitor CO2

    Full Information

    First Posted
    December 15, 2022
    Last Updated
    December 29, 2022
    Sponsor
    Nottingham University Hospitals NHS Trust
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05674760
    Brief Title
    ReAcT CO2: A Study to Assess TcCO2 to Guide Acute NIV
    Acronym
    ReAcTCO2
    Official Title
    Noninvasive Monitoring for Noninvasive Ventilation: Use of Transcutaneous Carbon Dioxide Monitoring to Guide Acute Noninvasive Ventilation in Patients With Acute Hypercapnic Respiratory Failure: A Multicenter Study
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    December 2022
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    February 10, 2023 (Anticipated)
    Primary Completion Date
    February 7, 2024 (Anticipated)
    Study Completion Date
    February 10, 2024 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Nottingham University Hospitals NHS Trust

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    Arterial blood sampling is needed to monitor carbon dioxide and PH but is often painful. The aim of this study is to determine whether continuous carbon dioxide monitoring with a skin probe reduces the need for arterial blood sampling by at least 30%. The investigators will also study the safety and effectiveness of skin probe monitoring to manage non-invasive ventilation (NIV).
    Detailed Description
    Patients with breathing difficulty need arterial blood sampling to check carbon dioxide levels. This is difficult, painful, associated with complications and often met with delays. The investigators have shown in a previous observational study, that using a skin probe to monitor carbon dioxide levels in patients with acute breathing difficulty was far more comfortable, significantly less painful and importantly closely reflected arterial carbon dioxide levels. Decisions regarding breathing support with mask (noninvasive ventilation or NIV) were however based on arterial blood samples collected simultaneously. In this feasibility study over 72 hours, patients will either have arterial blood sampling or skin probe to monitor carbon dioxide levels. The aim of the study is to determine whether continuous carbon dioxide monitoring with a skin probe reduces the need for arterial blood sampling by at least 30%. Investigators will also study the safety and effectiveness of skin probe monitoring to manage NIV. Towards this the investigators will study patients admitted with sudden worsening of breathing that has led to a build up of carbon dioxide. Patients will be recruited within 8 hours, although preferably within 4 hours of starting NIV, preferably in the Emergency Department(ED). Their carbon dioxide levels will then be monitored by skin probe (TcCO2 group) or arterial blood gas (ABG) sampling. Clinicians can perform ABGs in TcCO2 group at their discretion. Our main end point is the total number of ABGs performed in each group. Clinicians will complete a questionnaire for unscheduled ABGs in TcCO2 group. The investigators will also measure any side effects, pain experienced by patients in each group and ease of using each technique as well as explore barriers to using transcutaneous monitoring and identify any drawbacks of this method.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Acute Hypercapnic Respiratory Failure

    7. Study Design

    Primary Purpose
    Health Services Research
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Model Description
    Open Label Randomised Controlled Trial
    Masking
    Outcomes Assessor
    Masking Description
    The statistician assessing the outcomes will be blinded to the randomisation
    Allocation
    Randomized
    Enrollment
    60 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Arterial Blood Gas (ABG) arm - Control arm
    Arm Type
    Active Comparator
    Arm Description
    Patients in this arm will undergo arterial blood gas sampling to monitor CO2 as per the British Thoracic Society guidance which is standard practice.
    Arm Title
    transcutaneous CO2 arm
    Arm Type
    Experimental
    Arm Description
    Patients in this arm will undergo transcutaneous monitoring to monitor CO2. This will be the experimental arm.
    Intervention Type
    Device
    Intervention Name(s)
    Trancutaneous CO2 monitoring (using TCM5 device)
    Intervention Description
    Patients in the Transcutaneous arm will undergo Trancutaneous CO2 monitoring (using TCM5 device)
    Intervention Type
    Other
    Intervention Name(s)
    Arterial Blood Gas (ABG) sampling
    Intervention Description
    Arterial Blood Gas (ABG) sampling to monitor CO2 - as per standard practice.
    Primary Outcome Measure Information:
    Title
    Average number of arterial blood gases per participant over the study period
    Description
    the total (Scheduled and unscheduled) arterial blood samples over 72 hours per participant in each group .
    Time Frame
    over the study period of 72 hours per participant
    Title
    number of unscheduled arterial blood sample in each group
    Description
    arterial blood sampling needed for clinical deterioration or due to unreliability of transcutaneous CO2 monitoring for each patient
    Time Frame
    over the study period of 72 hours per participant
    Title
    number of instances where transcutaneous monitoring was unreliable and arterial blood gas sampling was needed.
    Description
    Clinicians will complete questionnaires regarding the need for unscheduled arterial blood samples and changes in management due to these incidences of arterial blood sampling in the transcutaneous monitoring group.
    Time Frame
    over the total study period of 72 hours per patient
    Secondary Outcome Measure Information:
    Title
    Pain and any discomfort from arterial blood sampling and transcutaneous monitoring using a visual analogue scale from 0 to 10 with 0 being no pain and 10 being the worst pain they have ever experienced
    Description
    Pain and any discomfort (such as skin burns, blisters, erythema, bruising or restriction of physical activity) from arterial blood sampling and transcutaneous monitoring
    Time Frame
    over the study period of 72 hours per participant
    Title
    Proportion of patients admitted with acute hypercapnic respiratory failure that are suitable and agree to participate in the study over one year (to help guide future studies).
    Description
    Suitability and feasibility
    Time Frame
    Over the total study period of 1 year.
    Title
    Proportion of patients who achieve 50% drop in carbon dioxide in 12 hours and those who achieve carbon dioxide level of 7 kPa or less in 72 hours in each group.
    Description
    Proportion of patients who achieve 50% drop in carbon dioxide in 12 hours and those who achieve carbon dioxide level of 7 kPa or less in 72 hours in each group.
    Time Frame
    over the study period of 72 hours per participant
    Title
    Proportion of patients who need further changes to ventilator settings beyond 4 hours and 24 hours
    Description
    How quickly can we optimise NIV settings
    Time Frame
    over the study period of 72 hours per participant
    Title
    Proportion of patients with deterioration in CO2 at 4 and 24 hours after NIV initiation
    Description
    Can TcCO2 identify deteriorating patients quicker
    Time Frame
    over the study period of 72 hours per participant
    Title
    Proportion of patients who get better and are discharged and proportion that fail to respond and either need mechanical ventilation / progress to palliative care.
    Description
    Proportion of patients who get better and are discharged and proportion that fail to respond and either need mechanical ventilation / progress to palliative care.
    Time Frame
    over the study period of 72 hours per participant
    Title
    Transcutaneous arm only - agreement between arterial and transcutaneous readings:
    Description
    a) absolute CO2 values obtained within 30 minutes of each other will be tested using Bland Altman plot; b) trend between serial ABG CO2 values and transcutaneous CO2 readings when ABGs performed (scheduled and unscheduled ABG will be assessed separately).
    Time Frame
    over the study period of 72 hours per participant
    Title
    Discrete choice: what method would patients prefer for monitoring during similar future illness requiring NIV?
    Description
    Do patients prefer one method of monitoring over the other. This is reasonable to ask all those randomized to TcCO2 as they will experience both ABG and TcCO2
    Time Frame
    over the study period of 72 hours per participant
    Title
    Clinician Preference questionnaire: whether they prefer ABG versus transcutaneous CO2 monitoring
    Description
    Taking into consideration time and difficulty, plus certainty of implementing changes to NIV settings and weaning, with respect to modality of carbon dioxide monitoring.
    Time Frame
    over the total study period of 1 year
    Title
    Time needed to wean off NIV in each group i.e. time from documented clinician decision to wean, until time of cessation of NIV.
    Description
    This would help assess whether transcutaneous CO2 monitoring allows for quicker weaning from NIV.
    Time Frame
    over the study period of 72 hours per participant
    Title
    Basic Health economics data will be gathered to assess whether transcutaneous monitoring is a cost effective way compared to arterial blood gas sampling.
    Description
    Cost effectiveness of the two methods to monitor CO2
    Time Frame
    over the total study period of 1 year

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Patients aged18 years and over with hypercapnia, requiring acute NIV and who are admitted to the Emergency Department or Medical HDU and, who need arterial blood sampling for clinical reasons. Recruited ideally within 4 hours (but no later than 8 hours) of initiation of acute NIV in hospital. Exclusion Criteria: Reduced level of consciousness or agitation. Metabolic or mixed acidosis, serum bicarbonate < 24 mmol/L. Haemodynamic instability or reduced skin perfusion. Patients requiring more than 6litres/min (ormorethan60%) inspired oxygen through ventilator to maintain SpO2 of 88-92%. Need for multi-organ support e.g. inotropes or vasopressors or renal replacement therapy Arterial pH equal or less than 7.1 or carbon dioxide levels >15kPa as they are at risk of NIV failure and likely to require mechanical ventilation. Participating in any other interventional study

    12. IPD Sharing Statement

    Plan to Share IPD
    No

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    ReAcT CO2: A Study to Assess TcCO2 to Guide Acute NIV

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