NCT06483984 Noninvasive Ventilation Facemasks Favoring Carbon Dioxide Washout
| NCT ID | NCT06483984 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Fondazione Policlinico Universitario Agostino Gemelli IRCCS |
| Condition | Respiratory Insufficiency |
| Study Type | INTERVENTIONAL |
| Enrollment | 20 participants |
| Start Date | 2024-11-15 |
| Primary Completion | 2026-10-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 20 participants in total. It began in 2024-11-15 with a primary completion date of 2026-10-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 Criteria
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.
Contact & Investigator
Massimo Antonelli, MD
STUDY CHAIR
Catholic University of the Sacred Heart
Frequently Asked Questions
Who can join the NCT06483984 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Respiratory Insufficiency. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06483984 currently recruiting?
Yes, NCT06483984 is actively recruiting participants. Contact the research team at domenicoluca.grieco@unicatt.it for enrollment information.
Where is the NCT06483984 trial being conducted?
This trial is being conducted at Roma, Italy, Rome, Italy.
Who is sponsoring the NCT06483984 clinical trial?
NCT06483984 is sponsored by Fondazione Policlinico Universitario Agostino Gemelli IRCCS. The principal investigator is Massimo Antonelli, MD at Catholic University of the Sacred Heart. The trial plans to enroll 20 participants.