Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 2:08 AM
Ignite Modification Date:
2025-12-25 @ 2:08 AM
NCT ID:
NCT05674760
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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT05674760
Study Brief:
Protocol Section:
NCT05674760