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:
2025-12-24 @ 1:21 PM
Ignite Modification Date:
2025-12-24 @ 1:21 PM
NCT ID:
NCT06007495
Eligibility Criteria:
Inclusion Criteria:
* No indication of intubation upon evaluation by physician in the next 2 hours
* Fits the investigational mask
Specific for hypercapnic patients 1 of the following criteria
* Patients hospitalized with acute respiratory failure (ARF) stabilized and tolerating NIV or;
* Patient admitted to hospital with ARF with one criteria for NIV among the following:
* Acute hypercapnic respiratory failure with hypercapnia and acidosis (Partial pressure of arterial carbon dioxide (PaCO2) \> 45 millimeters of mercury (mmHg) and pH \< 7.38) or
* Post-extubation period within 48 hours, in patients with high risk of re-intubation
Specific for hypoxemic patients
1 of the following criteria
* Hypoxemic respiratory failure without hypercapnia requiring nasal high flow or;
* Hypoxemic respiratory failure without hypercapnia requiring NIV or;
* Conventional oxygen therapy (COT) \> 6 liters per minute (L/min) with peripheral oxygen saturation (SpO2) \< 92%
Exclusion Criteria:
* Refusal to participate in the study
* Inability to provide informed consent
* Infectious isolation
* Facial deformity, burns or morphology that prevents adequate mask placement
* Claustrophobia
* Nausea
* Presence of nasogastric tube
* Pneumothorax
* Confusion or loss of consciousness
* Severe upper gastro-intestinal bleeding
* Any other condition, which at the investigators discretion, is believed may present a safety risk or impact the feasibility of the study or study results
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT06007495
Study Brief:
Protocol Section:
NCT06007495