Noninvasive Ventilation Facemasks Favoring Carbon Dioxide Washout
- Conditions
- Respiratory Insufficiency
- Interventions
- Device: Noninvasive ventilation
- Registration Number
- NCT06483984
- Brief Summary
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
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 20
Acute respiratory failure with
- PaCO2 ≥ 45 mmHg;
- Arterial pH < 7.35;
- Signed written informed consent
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Bridge-free facemask 'Visairo' Noninvasive ventilation Bridge-free facemask for noninvasive ventilation. This Bridge-Free NIV contacts the patient's nose only on the nostrils Facemask 'Nivairo' Noninvasive ventilation Oronasal mask for noninvasive ventilation Facemask 'Optiniv' Noninvasive ventilation Facemask for noninvasive ventilation favoring carbon dioxide washout
- Primary Outcome Measures
Name Time Method Metabolic work of breathing 45 minutes Simplified pressure-time-product per minute of the transdiaphragmatic pressure
- Secondary Outcome Measures
Name Time Method Arterial carbon dioxide, expressed in mmHg 45 minutes Arterial carbon dioxide, measured with arterial blood gas analysis
Normalized metabolic work of breathing 45 minutes Simplified pressure-time-product per minute of the transdiaphragmatic pressure normalized to arterial carbon dioxide divided by 45 mmHg
Inspiratory effort, expressed in cmH2O 45 minutes Positive inspiratory deflection of transdiaphragmatic pressure
Discomfort 45 minutes Discomfort, defined according to visual analog scale of discomfort (0-10, where 10 represents worst perceivable discomfort).
End-expiratory lung volume 45 minutes Global impedance-derived end-expiratory lung volume (EELI), measured with electrical impedance tomography
Corrected minute ventilation 45 minutes Minute ventilation assessed with electrical impedence tomography, normalized to normalized to arterial carbon dioxide divided by 45 mmHg
Dyspnea 45 minutes Dyspnoea, defined according to visual analog scale of dyspnea (0-10, where 10 represents worst perceivable dyspnea).
Regional End-expiratory lung volume 45 minutes Regional (ventral-midventral-middorsal-dorsal) impedance-derived end-expiratory lung volume (EELI), measured with electrical impedance tomography
Arterial acid-base state 45 minutes Arterial pH, measured with arterial blood gas analysis
Recuitment of expiratory muscles, expressed in cmH2O of gastric pressure 45 minutes Expiratory increases in gastrinc pressure
Tidal volume distribution 45 minutes Tidal volume distribution in the different lung regions (ventral-midventral-middorsal-dorsal),assessed with electrical impedance tomography
Trial Locations
- Locations (2)
General intensive care unit, Fondazione Policlinico A. Gemelli IRCCS
🇮🇹Roma, Italy
Fondazione Policlinico Universitaro A. Gemelli IRCCS
🇮🇹Rome, Italy