Ignite Creation Date:
2025-12-25 @ 2:08 AM
Ignite Modification Date:
2025-12-25 @ 2:08 AM
Study NCT ID:
NCT05674760
Status:
UNKNOWN
Last Update Posted:
2023-01-06
First Post:
2022-12-15
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
ReAcT CO2: A Study to Assess TcCO2 to Guide Acute NIV
Sponsor:
Nottingham University Hospitals NHS Trust
Organization:
Study Overview
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
Status:
UNKNOWN
Status Verified Date:
2022-12
Last Known Status:
NOT_YET_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ReAcTCO2
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.
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.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: