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

NCT ID: NCT05674760

Last Updated: 2023-01-06

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-02-10
• Study Completion Date: 2024-02-10

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.

Conditions

Acute Hypercapnic Respiratory Failure

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: SINGLE

Study Groups

Arterial Blood Gas (ABG) arm - Control arm

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

Group Type: ACTIVE_COMPARATOR

Arterial Blood Gas (ABG) sampling

Intervention Type: OTHER

Arterial Blood Gas (ABG) sampling to monitor CO2 - as per standard practice.

transcutaneous CO2 arm

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

Group Type: EXPERIMENTAL

Trancutaneous CO2 monitoring (using TCM5 device)

Intervention Type: DEVICE

Patients in the Transcutaneous arm will undergo Trancutaneous CO2 monitoring (using TCM5 device)

Interventions

Trancutaneous CO2 monitoring (using TCM5 device)

Patients in the Transcutaneous arm will undergo Trancutaneous CO2 monitoring (using TCM5 device)

Intervention Type: DEVICE

Arterial Blood Gas (ABG) sampling

Arterial Blood Gas (ABG) sampling to monitor CO2 - as per standard practice.

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Nottingham University Hospitals NHS Trust

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Other Identifiers

18RM021

Identifier Type: -

Identifier Source: org_study_id