Pilot Study Comparing an Investigational Full-Face Mask with Expiratory Washout to Conventional Masks for Non-Invasive Ventilation in Acute Respiratory Failure

What this Trial Is About

Researchers are evaluating an investigational full-face mask with expiratory washout designed to deliver non-invasive ventilation NIV therapy in patients with acute hypercapnic or hypoxemic respiratory failure. This pilot randomized cross-over study compares this new mask with conventional full-face masks on how they affect minute ventilation and other respiratory variables in patients already prescribed NIV. The study aims to understand whether the expiratory washout technique, which flushes carbon dioxide from the upper airway at the end of exhalation, improves ventilation compared to standard NIV masks. Participants will undergo three 30-minute study arms in a randomized order NIV with the investigational mask featuring expiratory washout using a single-limb setup, NIV with a conventional single-limb mask, and NIV with a conventional dual-limb mask. During each arm, NIV will be delivered with heated humidification, and ventilator settings will be adjusted to target specific tidal volumes and oxygen saturation ranges, based on patient condition. After completing all three arms 90 minutes total, participants will return to their usual NIV protocols. During the study, participants will first receive oxygen therapy via nasal cannula for 15 minutes while baseline measurements are recorded, including respiratory rate, tidal volume, minute ventilation, blood gases, dyspnea, and mask comfort scores. These measurements will be repeated at the end of each 30-minute NIV period. Researchers will monitor ventilation effectiveness and patient comfort throughout the study. After completion, participants resume standard care with their own physicians. The total data collection period spans approximately 1 hour and 45 minutes per participant.

Pilot Physiological Evaluation of an Investigational Mask with Expiratory Washout.