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:
2025-12-26 @ 4:01 PM
Ignite Modification Date:
2025-12-26 @ 4:01 PM
NCT ID:
NCT06004206
Eligibility Criteria:
Inclusion Criteria:
* Adult patients (\>18aa)
* Non Invasive Ventilation with helmet
* NG tubing for clinical use in position
* Invasive arterial monitoring for clinical use in position
Exclusion Criteria:
* Unable to express consent
* Expected NIV \< 24hrs
* Gastric-esophageal surgery in the preceding 12 months
* Upper-GI bleeding in the last 30 days
* History of esophageal varices
* Recent trauma or facial surgery
* Haemodynamic instability even a after liquid infusion (need of at least dopamine \>5 γ/kg/min or norepinephrine \>0.1 γ/kg min to obtain systolic pressure \>90 mmHg)
* Core temperature \>30 C°
* Coagulation disorders (INR \> 1.5 and/or aPTT \>44 sec)
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT06004206
Study Brief:
Protocol Section:
NCT06004206