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For example, 100 patients had a low PRODIGY score and of these 47 had RD with a median 0 number of RD episodes per patient, while 70 patients had a high PRODIGY score and of these 59 had RD with 5 RD episodes per patient, P<0.001. Also, the number of RD episodes per patient increased with higher PRODIGY scores. One hundred and fifty-five patients had an RD episode, and of these 136 (88%) had multiple episodes. Recently, we conducted a secondary analysis of 250 patients from two participating centers to better understand these multiple episodes.² We confirmed our impression that RD episodes were rarely isolated. During the study, we noticed that many patients who had an RD episode often had multiple episodes. For PRODIGY, capnography and pulse oximetry tracings were obtained on standard hospital wards and reviewed to determine if patients had an episode of RD. Five independent variables that included age ≥60 (in decades), sex, opioid naïvety, sleep disordered breathing, and chronic heart failure were part of a multivariable respiratory depression prediction model with an area under the curve (AUC) of 0.76 (table 1). 1 One or more respiratory depression episodes were detected in 614 (46%) of 1,335 general care floor patients (43% male, mean age 58☑4 years) who were continuously monitored for a median of 24 hrs (IQR 17-26). The primary aim of PRODIGY was to define the incidence of opioid-induced respiratory depression (OIRD) and to create a multivariable risk prediction tool (i.e., PRODIGY score) to predict respiratory depression (RD) in hospitalized patients. The study’s pre-defined respiratory depression episodes included any of the following: respiratory rate ≤5 bpm, oxygen saturation ≤85%, or end-tidal carbon dioxide ≤15 or ≥60 mmHg for ≥3 minutes apnea episode lasting >30 seconds or any respiratory opioid-related adverse event. Vital signs were intermittently monitored per standard of care and hospital protocol. A total of 1,335 patients receiving parenteral opioids were continuously monitored with provider-blinded capnography and oximetry on general care floors.
PRODIGY ANESTHESIA TRIAL
1 This was a prospective, observational trial of blinded continuous capnography and oximetry, conducted at 16 sites in the United States, Europe, and Asia. The results of the “ PRediction of Opioid-induced respiratory Depression In patients monitored by capnoGraphY” (PRODIGY) clinical trial were published last year. However, the following information is applicable across a broad spectrum of equipment types. Editor’s Note: The Prodigy trial was funded by Medtronic.