An interventional study of Trancutaneous CO2 monitoring (using TCM5 device) and Arterial Blood Gas (ABG) sampling in Acute Hypercapnic Respiratory Failure, sponsored by Nottingham University Hospitals NHS Trust. Status unknown. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-01-06.
Sponsored by Nottingham University Hospitals NHS Trust · Not applicable, Interventional, and Health services research
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).
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.
1,650 studies on the registry are indexed under Respiratory Insufficiency; 296 are open to participants now.
This study's planned enrollment of 60 is close to the median of 55 across 1,043 interventional studies indexed under Respiratory Insufficiency.
Browse Respiratory Insufficiency studies →Nottingham University Hospitals NHS Trust is the lead sponsor of 104 studies on the registry; 19 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Patients in this arm will undergo arterial blood gas sampling to monitor CO2 as per the British Thoracic Society guidance which is standard practice.
Other: Arterial Blood Gas (ABG) sampling
Patients in this arm will undergo transcutaneous monitoring to monitor CO2. This will be the experimental arm.
Device: Trancutaneous CO2 monitoring (using TCM5 device)
Patients in the Transcutaneous arm will undergo Trancutaneous CO2 monitoring (using TCM5 device)
Arterial Blood Gas (ABG) sampling to monitor CO2 - as per standard practice.
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 .
Time frame: over the study period of 72 hours per participant
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
Time frame: over the study period of 72 hours per participant
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.
Time frame: over the total study period of 72 hours per patient
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
Time frame: over the study period of 72 hours per participant
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
Time frame: Over the total study period of 1 year.
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.
Time frame: over the study period of 72 hours per participant
Proportion of patients who need further changes to ventilator settings beyond 4 hours and 24 hours
How quickly can we optimise NIV settings
Time frame: over the study period of 72 hours per participant
Proportion of patients with deterioration in CO2 at 4 and 24 hours after NIV initiation
Can TcCO2 identify deteriorating patients quicker
Time frame: over the study period of 72 hours per participant
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.
Time frame: over the study period of 72 hours per participant
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).
Time frame: over the study period of 72 hours per participant
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
Time frame: over the study period of 72 hours per participant
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 frame: over the total study period of 1 year
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.
Time frame: over the study period of 72 hours per participant
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
Time frame: over the total study period of 1 year
No study locations are listed for this record.
Plan to share: No
No publications or documents are linked to this record.
This study is status unknown, as verified in Dec 2022. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Nottingham University Hospitals NHS Trust