OBJECTIVE: Compared to oronasal interfaces, a cephalic mask has a larger inner volume, covers the entire anterior surface of the face and limits the risk of deleterious cutaneous side effects during noninvasive ventilation (NIV). The present clinical study aimed to compare the clinical efficacy of a cephalic mask versus an oronasal mask in patients with acute hypercapnic respiratory failure (AHRF). DESIGN AND SETTING: Randomized controlled study in a Respiratory Intermediate Care Unit. PATIENTS: All consecutive patients admitted for AHRF were randomly assigned to receive bilevel NIV either with a cephalic mask (n = 17) or an oronasal mask (n = 17) during the first 48 h. MEASUREMENTS: The main outcome criterion was the improvement of arterial pH, 24 h after NIV initiation. Secondary criteria included PaCO(2) and physiological parameters. RESULTS: Compared to values at inclusion, pH, PaCO(2), encephalopathy score, respiratory distress score and respiratory frequency improved significantly and similarly with both masks. None of these parameters showed statistically significant differences between the masks at each time point throughout the study period. Mean delivered inspiratory and expiratory pressures were similar in both patient groups. Tolerance of the oronasal mask was improved at 24 h and further. One patient with the cephalic mask suffered from claustrophobia that did not lead to premature study interruption. CONCLUSIONS: In spite of its larger inner volume, the cephalic mask has the same clinical efficacy and requires the same ventilatory settings as the oronasal mask during AHRF.
RCT Entities:
OBJECTIVE: Compared to oronasal interfaces, a cephalic mask has a larger inner volume, covers the entire anterior surface of the face and limits the risk of deleterious cutaneous side effects during noninvasive ventilation (NIV). The present clinical study aimed to compare the clinical efficacy of a cephalic mask versus an oronasal mask in patients with acute hypercapnic respiratory failure (AHRF). DESIGN AND SETTING: Randomized controlled study in a Respiratory Intermediate Care Unit. PATIENTS: All consecutive patients admitted for AHRF were randomly assigned to receive bilevel NIV either with a cephalic mask (n = 17) or an oronasal mask (n = 17) during the first 48 h. MEASUREMENTS: The main outcome criterion was the improvement of arterial pH, 24 h after NIV initiation. Secondary criteria included PaCO(2) and physiological parameters. RESULTS: Compared to values at inclusion, pH, PaCO(2), encephalopathy score, respiratory distress score and respiratory frequency improved significantly and similarly with both masks. None of these parameters showed statistically significant differences between the masks at each time point throughout the study period. Mean delivered inspiratory and expiratory pressures were similar in both patient groups. Tolerance of the oronasal mask was improved at 24 h and further. One patient with the cephalic mask suffered from claustrophobia that did not lead to premature study interruption. CONCLUSIONS: In spite of its larger inner volume, the cephalic mask has the same clinical efficacy and requires the same ventilatory settings as the oronasal mask during AHRF.
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