Testing different facemasks for noninvasive ventilation in respiratory failure

Physiological Effects of Novel Noninvasive Ventilation Facemasks Favoring Carbon Dioxide Washout in Patients With Hypercapnic Respiratory Failure

This study tests which of three different facemasks works best for helping people with severe breathing problems get rid of carbon dioxide.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 20 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS (Academic / other)
• Locations: 2 sites (Roma and 1 other locations)
• Trial ID: NCT06483984 on ClinicalTrials.gov

What this trial studies

This trial evaluates the physiological effects of three types of facemasks used for noninvasive ventilation in patients experiencing acute hypercapnic respiratory failure. Participants will be randomly assigned to use either the Nivairo, Visairo, or Optiniv facemask to determine which is most effective at facilitating carbon dioxide washout. The study aims to improve treatment options for patients with respiratory insufficiency by comparing these interventions. The trial will include measurements of arterial blood gases and other relevant physiological parameters.

Who should consider this trial

Good fit: Ideal candidates are patients with acute respiratory failure characterized by elevated carbon dioxide levels and low arterial pH.

Not a fit: Patients who require immediate intubation or have severe hemodynamic instability will not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to improved noninvasive ventilation strategies for patients with respiratory insufficiency.

How similar studies have performed: While there have been studies on noninvasive ventilation, the specific comparison of these three facemasks is novel and has not been extensively tested.

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.

Where this trial is running

Roma and 1 other locations

• General intensive care unit, Fondazione Policlinico A. Gemelli IRCCS — Roma, Italy (Recruiting)
• Fondazione Policlinico Universitaro A. Gemelli IRCCS — Rome, Italy (Recruiting)

Study contacts

• Study coordinator: Domenico Luca Grieco, MD

Conditions Respiratory Insufficiency