Respiratory Insufficiency
Conditions
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
Interventions
DEVICENoninvasive ventilation
Respiratory support with a facemask connected to a ventilator through a heated humidifier. Ventilator will be set in the pressure support mode.
Sponsors
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Metabolic work of breathing | 45 minutes | Simplified pressure-time-product per minute of the transdiaphragmatic pressure |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Inspiratory effort, expressed in cmH2O | 45 minutes | Positive inspiratory deflection of transdiaphragmatic pressure |
| 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). |
| 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 |
| 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 |
| Arterial carbon dioxide, expressed in mmHg | 45 minutes | Arterial carbon dioxide, measured with arterial blood gas analysis |
| 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 |
| Regional End-expiratory lung volume | 45 minutes | Regional (ventral-midventral-middorsal-dorsal) impedance-derived end-expiratory lung volume (EELI), measured with electrical impedance tomography |
Countries
Italy
Contacts
Primary ContactDomenico Luca Grieco, MD
Outcome results
None listed