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 volunteersQualifiers
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
Crossover
Treatments tested in this trial
Noninvasive ventilation
DeviceRespiratory support with a facemask connected to a ventilator through a heated humidifier. Ventilator will be set in the pressure support mode.
Treatment groups
Trial outcomes
Primary outcomes
Metabolic work of breathing
Simplified pressure-time-product per minute of the transdiaphragmatic pressure
Secondary outcomes
Normalized metabolic work of breathing
Simplified pressure-time-product per minute of the transdiaphragmatic pressure normalized to arterial carbon dioxide divided by 45 mmHg
Inspiratory effort, expressed in cmH2O
Positive inspiratory deflection of transdiaphragmatic pressure
Corrected minute ventilation
Minute ventilation assessed with electrical impedence tomography, normalized to normalized to arterial carbon dioxide divided by 45 mmHg
Dyspnea
Dyspnoea, defined according to visual analog scale of dyspnea (0-10, where 10 represents worst perceivable dyspnea).
Sponsors and contacts
Click on the lead sponsor to view all of their trials.