Testing different facemasks for noninvasive ventilation in respiratory failure

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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
• Email: domenicoluca.grieco@unicatt.it
• Phone: +39063015

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.