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Search / Trial NCT06483984

Noninvasive Ventilation Facemasks Favoring Carbon Dioxide Washout

Launched by FONDAZIONE POLICLINICO UNIVERSITARIO AGOSTINO GEMELLI IRCCS · Jun 28, 2024

Trial Information

Current as of July 24, 2025

Recruiting

Keywords

ClinConnect Summary

This clinical trial is studying how different types of facemasks help people with serious breathing problems, specifically those who have high levels of carbon dioxide in their blood. The trial includes three different facemasks: Nivairo, Visairo, and Optiniv. Researchers want to see which mask works best for improving breathing and lowering carbon dioxide levels in patients who are experiencing acute respiratory failure.

To participate in this trial, individuals need to be between 65 and 74 years old and must have certain breathing issues, including high carbon dioxide levels and low blood pH. However, not everyone will qualify; for example, people who need immediate intubation (a tube to help them breathe) or have unstable blood pressure cannot join. If eligible, participants will wear different facemasks during the study to see how well each one helps with their breathing. This trial is currently recruiting participants, and those who join will have a chance to contribute to important research that could improve treatments for patients with respiratory difficulties.

Gender

ALL

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.

About Fondazione Policlinico Universitario Agostino Gemelli Irccs

Fondazione Policlinico Universitario Agostino Gemelli IRCCS is a leading research and healthcare institution based in Rome, Italy, renowned for its commitment to advancing medical science and improving patient care. As a prominent academic medical center affiliated with the Catholic University of the Sacred Heart, it integrates clinical practice, education, and research, fostering innovation in various fields of medicine. The foundation conducts a wide range of clinical trials aimed at developing new therapies and enhancing treatment protocols, with a focus on translational research that bridges the gap between laboratory discoveries and patient care. Its multidisciplinary approach and dedication to high ethical standards position it as a key player in the landscape of clinical research and healthcare improvement in Italy and beyond.

Locations

Rome, , Italy

Roma, , Italy

Patients applied

0 patients applied

Trial Officials

Massimo Antonelli, MD

Study Chair

Catholic University of the Sacred Heart

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported