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

NCT05674760 | Unknown DMC

• 1 other identifier: 18RM021
• Study Type: interventional
• Target: 60
• Locations: 0 countries
• Sites: N/A

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).

Conditions

Acute Hypercapnic Respiratory Failure

Outcome Measures

Primary Outcomes (3)

• 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 .

  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

  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.

  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

  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).

  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.

  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

  over the study period of 72 hours per participant

• Proportion of patients with deterioration in CO2 at 4 and 24 hours after NIV initiation

  over the study period of 72 hours per participant

Study Arms (2)

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.

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.

Device: Trancutaneous CO2 monitoring (using TCM5 device)

Interventions

Trancutaneous CO2 monitoring (using TCM5 device) DEVICE

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

transcutaneous CO2 arm

Arterial Blood Gas (ABG) sampling OTHER

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

Arterial Blood Gas (ABG) arm - Control arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Nottingham University Hospitals NHS Trust: lead

MeSH Terms

Conditions

Respiratory Insufficiency

Interventions

Blood Gas Analysis

Condition Hierarchy (Ancestors)

Respiration Disorders; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Blood Chemical Analysis; Clinical Chemistry Tests; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Respiratory Function Tests; Diagnostic Techniques, Respiratory System; Investigative Techniques

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The statistician assessing the outcomes will be blinded to the randomisation
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Open Label Randomised Controlled Trial

Study Record Dates

• First Submitted: December 15, 2022
• First Posted: January 6, 2023
• Study Start: February 10, 2023
• Primary Completion: February 7, 2024
• Study Completion: February 10, 2024
• Last Updated: January 6, 2023

Record last verified: 2022-12

Data Sharing

• IPD Sharing: Will not share