Noninvasive Ventilation Facemasks Favoring Carbon Dioxide Washout

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorFondazione Policlinico Universitario Agostino Gemelli IRCCS

About this trial

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

This trial does not accept healthy volunteers

Qualifiers

PaCO2 ≥ 45 mmHg;

Arterial pH < 7.35;

Signed written informed consent

Disqualifiers

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;

Trial design

Design model

Crossover

Treatments tested in this trial

  • Noninvasive ventilation

    Device

    Respiratory support with a facemask connected to a ventilator through a heated humidifier. Ventilator will be set in the pressure support mode.

Treatment groups

20 Participants
are divided into 3 treatment groups
Group A: Facemask 'Nivairo'Active comparator 1 intervention
Group B: Bridge-free facemask 'Visairo'Experimental treatment 1 intervention
Group C: Facemask 'Optiniv'Experimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Metabolic work of breathing

Simplified pressure-time-product per minute of the transdiaphragmatic pressure

Time frame
45 minutes

Secondary outcomes

1

Normalized metabolic work of breathing

Simplified pressure-time-product per minute of the transdiaphragmatic pressure normalized to arterial carbon dioxide divided by 45 mmHg

Time frame
45 minutes
2

Inspiratory effort, expressed in cmH2O

Positive inspiratory deflection of transdiaphragmatic pressure

Time frame
45 minutes
3

Corrected minute ventilation

Minute ventilation assessed with electrical impedence tomography, normalized to normalized to arterial carbon dioxide divided by 45 mmHg

Time frame
45 minutes
4

Dyspnea

Dyspnoea, defined according to visual analog scale of dyspnea (0-10, where 10 represents worst perceivable dyspnea).

Time frame
45 minutes

Other outcomes

Sponsors and contacts

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