Clinical Trials in Italy / NCT06483984
Recruiting
Not applicable
Noninvasive Ventilation Facemasks Favoring Carbon Dioxide Washout
NCT06483984 · tracked via the Priya Life Science Italy tracker
Condition(s) studied
Respiratory Insufficiency
Investigational drug(s) / intervention(s)
Noninvasive ventilation
Noninvasive ventilation: Respiratory support with a facemask connected to a ventilator through a heated humidifier. Ventilator will be set in the pressure support mode.
Study summary
The objective of this randomized cross-over trial is to assess the physiological effects of three different facemasks for noninvasive ventilation (Nivairo, Visairo, Optiniv) in patients with acute hypercapnic respiratory failure
Eligibility
Inclusion Criteria:
Acute respiratory failure with
* PaCO2 ≥ 45 mmHg;
* Arterial pH \< 7.35;
* Signed written informed consent
Exclusion Criteria:
* Respiratory rate \< 12 bpm;
* Immediate need for intubation;
* Haemodynamic instability (Systolic blood pressure \<90 mmHg or mean arterial pressure \<65 mmHg) and/or lactic acidosis (lactate \>5 mmol/L) and/or clinically diagnosed shock;
* Metabolic Acidosis;
* Recent head surgery or anatomy that prevent the application of facemasks;
* Any contraindications to oesophageal balloon insertion and/or electrical impedance tomography (EIT) belt placement.
* Any contraindications to facemask noninvasive ventilation.
Primary outcome measure(s)
- Metabolic work of breathing — 45 minutes
Simplified pressure-time-product per minute of the transdiaphragmatic pressure
Trial sites (2)
| Facility | City | Region | Status |
|---|---|---|---|
| General intensive care unit, Fondazione Policlinico A. Gemelli IRCCS | Roma | Italy | Recruiting |
| Fondazione Policlinico Universitaro A. Gemelli IRCCS | Rome | Italy | Recruiting |
More Fondazione Policlinico Universitario Agostino Gemelli IRCCS trials in Italy
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Active, not recruiting
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Official registry record
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT06483984 on ClinicalTrials.gov ↗ ← All trials in Italy