Noninvasive Ventilation Facemasks Favoring Carbon Dioxide Washout

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

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.