At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
CPAP Therapy Through a Helmet or a Full Face Mask in Patients With Acute Hypoxemic Respiratory Failure: a Comparative, Cross-over, Physiological Study
In Brief
A clinical study evaluating Arterial blood gases, Respiratory rate (RR), and 6 other interventions for Pneumonia, Bacterial and 2 related conditions. Completed, enrolled 30 participants across 1 site.
Detailed Summary
Observational and randomized trials have demonstrated the high effectiveness of non-invasive helmet ventilatory support, demonstrating a reduction in intubation rate mortality compared with high-flow and standard oxygen therapy. Some pilot physiological studies have shown physiological benefits of helmets compared to the oronasal mask for non-invasive ventilation. The purpose of the study is to compare markers of patient self-inflicted lung injury (P-SILI), patient's comfort, work of breathing, gas exchange, and hemodynamics in patients with acute hypoxemic respiratory failure (AHRF) during non-invasive ventilation (NIV) in continuous positive pressure (CPAP) mode during an oronasal mask ventilation or a combination of a helmet with high-flow oxygenation as an air flow generator.
Study Details
Timeline
Interventions
Measurement of arterial oxygen and tension and arterial dioxide tension, calculation of arterial partial oxygen tension to inspiratory oxygen fraction (PaO2/FiO2) ratio
Measurement of respiratory rate by waveform analysis using a ventilator
Peripheral capillary oxygen saturation (SpO2) measurement and the ROX-index calculation (SpO2/FiO2/RR)
Patrick score calculation. Score: 0. No visible tonic or phasic use of neck muscles. 1. Neck muscles taut but with no respiratory modulation (i.e., tonic activity). 2. Mild respiratory modulation in neck muscle contraction. 3. Moderate phasic activity (no supraclavicular or intercostal indrawing). 4. Vigorous phasic activity with indrawing. 5. Vigorous phasic activity with abdominal paradox.
Esophageal pressure measurement on inspiration and expiration with calculation of delta esophageal pressure, transpulmonary pressure and delta transpulmonary pressure
From 1 to 10 points, where 1 point - maximal discomfort, 10 points - minimal discomfort.
Noninvasive blood pressure
Heart rate calculation using electrocardiogram monitoring