Acute Hypercapnic Respiratory FailureReAcTCO2NCT05674760

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

A study testing Trancutaneous CO2 monitoring (using TCM5 device) and Arterial Blood Gas (ABG) sampling in people with Acute Hypercapnic Respiratory Failure, run by Nottingham University Hospitals NHS Trust.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record

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Trial 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%. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Acute Hypercapnic Respiratory Failure
What is being tested?: Trancutaneous CO2 monitoring (using TCM5 device) and Arterial Blood Gas (ABG) sampling
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 60 participants
Where: No sites listed yet
Study dates: 10 Feb 2023to 10 Feb 2024
Phase: Interventional
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
No healthy volunteers
Adult, Older adult

Who may be able to join

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.

Who cannot join

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

About this study

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

Read the 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.

Conditions: Acute Hypercapnic Respiratory Failure
Being tested: Trancutaneous CO2 monitoring (using TCM5 device), Arterial Blood Gas (ABG) sampling
Medical subject headings: Respiratory Insufficiency

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Trancutaneous CO2 monitoring (using TCM5 device)Device
Patients in the Transcutaneous arm will undergo Trancutaneous CO2 monitoring (using TCM5 device)
Arterial Blood Gas (ABG) samplingOther
Arterial Blood Gas (ABG) sampling to monitor CO2 - as per standard practice.

Study groups in NCT05674760
Study group	Role	What they receive
Arterial Blood Gas (ABG) arm - Control arm	Active comparator	Patients in this arm will undergo arterial blood gas sampling to monitor CO2 as per the British Thoracic Society guidance which is standard practice. Receives: Other: Arterial Blood Gas (ABG) sampling
transcutaneous CO2 arm	Experimental	Patients in this arm will undergo transcutaneous monitoring to monitor CO2. This will be the experimental arm. Receives: Device: Trancutaneous CO2 monitoring (using TCM5 device)

What is being measured

The primary outcome is the main question the study is designed to answer.

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 .
Measured: 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
Measured: 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.
Measured: over the total study period of 72 hours per patient

Secondary outcomes (11)

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
Measured: 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
Measured: 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.
Measured: 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
Measured: 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
Measured: 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.
Measured: over the study period of 72 hours per participant
Transcutaneous arm only - agreement between arterial and transcutaneous readings:
1. 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).
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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
Measured: over the total study period of 1 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

10 Feb 202310 Feb 2024

First posted6 Jan 2023
Study start10 Feb 2023 (estimated)
Primary completion7 Feb 2024 (estimated)
Study completion10 Feb 2024 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Acute 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: Interventional
Phase: Phase N/A
Primary purpose: Health services research
Allocation: Randomised
Intervention model: Parallel groups
Model description: Open Label Randomised Controlled Trial
Masking: Single blind
Who is masked: Outcomes assessor
Enrolment: 60 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05674760
Sponsor's protocol ID: 18RM021
Acronym: ReAcTCO2
Status last verified: Dec 2022
First submitted: 15 Dec 2022
Last updated: 6 Jan 2023
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

Official record

Recruiting
Bedside Spirometry for Acute Lung Injury
Respiratory Insufficiency
Recruiting
Management of Post-operative Respiratory Failure by Using NIV and High Velocity Nasal Insufflation (HVNI)
Respiratory Failure Without Hypercapnia, Respiratory Failure With Hypercapnia
Not yet recruiting
Extracorporeal Carbon Dioxide Removal Plus Noninvasive Ventilation in Patients With COPD Not Eligible for Intubation
Acute Exacerbation of Chronic Obstructive Pulmonary Disease
Not yet recruiting
ICU-SUCCEED for Survivors of Acute Respiratory Failure and Their Caregivers
Acute Respiratory Failure, Critical Illness
Recruiting
Nasal High Flow Versus Non-invasive Ventilation for Early Treatment of Acute Exacerbation of Chronic Obstructive Pulmonary Disease With Hypercapnic Acidosis
Acute Exacerbation of Chronic Obstructive Pulmonary Disease, Hypercapnic Acidosis

All Acute Hypercapnic Respiratory Failure trials

Study at a glance

From the registry record, last updated by the sponsor on 6 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT05674760
Acronym / sponsor ID: ReAcTCO2 / 18RM021
Conditions: Acute Hypercapnic Respiratory Failure
Study type: Interventional
Recruitment status: Unknown status
Enrolment: 60 participants (estimated)
Lead sponsor: Nottingham University Hospitals NHS TrustUniversity, hospital or other
Study start: 10 Feb 2023 (estimated)
Primary completion: 7 Feb 2024 (estimated)
Study completion: 10 Feb 2024 (estimated)
First posted: 6 Jan 2023 (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.

Detailed description

In this feasibility study over 72 hours, patients will either have arterial blood sampling or skin probe to monitor carbon dioxide levels.

Study design

Primary purpose: Health services research
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (outcomes assessor)
Number of arms: 2
Model description: Open Label Randomised Controlled Trial

Arm	Type	Receives
Arterial Blood Gas (ABG) arm - Control arm	Active comparator	Other: Arterial Blood Gas (ABG) samplingPatients in this arm will undergo arterial blood gas sampling to monitor CO2 as per the British Thoracic Society guidance which is standard practice.
transcutaneous CO2 arm	Experimental	Device: Trancutaneous CO2 monitoring (using TCM5 device)Patients in this arm will undergo transcutaneous monitoring to monitor CO2. This will be the experimental arm.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (2 listed)

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.

Key exclusion criteria (7 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Trancutaneous CO2 monitoring (using TCM5 device)Patients in the Transcutaneous arm will undergo Trancutaneous CO2 monitoring (using TCM5 device)	Device	transcutaneous CO2 arm
Arterial Blood Gas (ABG) samplingArterial Blood Gas (ABG) sampling to monitor CO2 - as per standard practice.	Other	Arterial Blood Gas (ABG) arm - Control arm

Primary outcome

Average number of arterial blood gases per participant over the study period
Time frame: over the study period of 72 hours per participant
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
Time frame: over the study period of 72 hours per participant
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.
Time frame: over the total study period of 72 hours per patient
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.

11 secondary outcomes

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
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).
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.
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
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
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.
Time frame: over the study period of 72 hours per participant
Transcutaneous arm only - agreement between arterial and transcutaneous readings:
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?
Time frame: over the study period of 72 hours per participant
Clinician Preference questionnaire: whether they prefer ABG versus transcutaneous CO2 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.
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.
Time frame: over the total study period of 1 year

Results and safety

Results are not available in the source record.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 6 Jan 2023.
Individual participant dataSharing planned: No

Related trials for Acute Hypercapnic Respiratory Failure

Recruiting
Bedside Spirometry for Acute Lung Injury
Respiratory Insufficiency
Recruiting
Management of Post-operative Respiratory Failure by Using NIV and High Velocity Nasal Insufflation (HVNI)
Respiratory Failure Without Hypercapnia, Respiratory Failure With Hypercapnia
Not yet recruiting
Extracorporeal Carbon Dioxide Removal Plus Noninvasive Ventilation in Patients With COPD Not Eligible for Intubation
Acute Exacerbation of Chronic Obstructive Pulmonary Disease
Not yet recruiting
ICU-SUCCEED for Survivors of Acute Respiratory Failure and Their Caregivers
Acute Respiratory Failure, Critical Illness
Recruiting
Nasal High Flow Versus Non-invasive Ventilation for Early Treatment of Acute Exacerbation of Chronic Obstructive Pulmonary Disease With Hypercapnic Acidosis
Acute Exacerbation of Chronic Obstructive Pulmonary Disease, Hypercapnic Acidosis

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.

The record lists no contact. Use the official record to reach the sponsor.

Questions about this trial

What is this clinical trial studying?

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 2 inclusion and 7 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: status not confirmed, as of the sponsor's last update on 6 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.

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?

Results are not available in the source record.

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?

Average number of arterial blood gases per participant over the study period (time frame: over the study period of 72 hours per participant). The study lists 3 primary outcomes in all. 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 NCT05674760.

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 6 Jan 2023.