NCT04241861.
| Study name | Physiological comparison of high‐flow nasal cannula, helmet pressure support ventilation and continuous positive airway pressure during acute hypoxemic respiratory failure: a randomized cross‐over study |
| Methods | RCT, cross‐over design. Interventions delivered in a random order for 40 minutes each |
| Participants | Number of estimated participants: 15 Setting: emergency department or ICU, Italy Inclusion criteria: adult hypoxemic non‐hypercapnic participants admitted to the emergency department or the ICU with de novo AHRF; respiratory rate > 25 breaths/min; PaO2/FiO2 ≤ 200; PaCO2 < 45 mmHg; absence of history of chronic respiratory failure or moderate to severe cardiac insufficiency; written informed consent Exclusion criteria: exacerbation of asthma or COPD; cardiogenic pulmonary oedema; haemodynamic instability; lactic acidosis (lactate > 5 mmol/L); clinically diagnosed shock; metabolic acidosis (pH < 7.30 with normal‐ or hypo‐carbia); GCS < 13; recent head surgery or anatomy that prevents the application of helmet or nasal cannula to patient's face |
| Interventions | Intervention group (HFNC): initial flow ≥ 50 L/min, decreased in case of intolerance to ≥ 30 L/min Control group 1 (NIV): helmet PSV; BiPAP; IPAP ≥ 8 to 10 cm H2O to permit inspiratory flow of 100mL/min; PEEP = 10 to 12 cm H2O increasing to achieve oxygenation target as required Control group 2 (NIV): helmet CPAP; continuous airflow = 50 to 60 L/min. PEEP = 10 to 12 cm H2O increasing to achieve oxygenation target as required FiO2 will be titrated to obtain SpO2 of 92‐98% for all groups |
| Outcomes | All outcomes measured: inspiratory effort; tidal volume; oxygenation; tidal volume distribution; PaCO2; dyspnoea; comfort; global and regional impedance‐derived end‐expiratory lung volumes and dynamic strains; dynamic transpulmonary driving pressure; respiratory system dynamic compliance; pendelluft; work of breathing Outcomes relevant to this review: oxygenation; work of breathing; dyspnoea; comfort; PaCO2 |
| Starting date | 27th January 2020 |
| Contact information | Domenico L Grieco, dlgrieco@outlook.it |
| Notes |