Finding studies
Finding studies
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Tracy S Williams, R.N.
CONTACT
Andrew J Mannes, M.D.
CONTACT
Lead
National Institutes of Health Clinical Center (CC)
Study Description: Proof of Concept pilot study to support use of a miniature in-line patient respirator for patient ventilation needs. Objectives: Primary Objective: To assess the effectiveness of the miniature respirator to ventilate intubated braindead research donors while maintaining respiratory measures within acceptable range. Secondary Objective The miniature respirator performs as designed and tested in a lung simulator. Endpoints: Primary Endpoint: A binary variable equal to 1 ("success") if both of the following criteria are met (during the placement of the test device): 1. the respirator maintains the end tidal CO(2) between 35- and 45-mm Hg; and 2. the O(2) saturation measured by pulse oximetry is \> 94%. Otherwise, the primary endpoint is equal to 0 ("failure"). Secondary Endpoints: Binary variables equal to 1 ("success") if tidal volume and airway pressure settings (PEEP and maximum peak airway pressure) are within 30% of predicted values. Otherwise, the secondary endpoints are equal to 0 ("failure").
Age
1–100
Sex
ALL
Healthy volunteers
Not accepted
