PMID- 35405725 OWN - NLM STAT- MEDLINE DCOM- 20221206 LR - 20230928 IS - 1549-8425 (Electronic) IS - 1549-8417 (Print) IS - 1549-8417 (Linking) VI - 18 IP - 8 DP - 2022 Dec 1 TI - Continuous Monitoring Detected Respiratory Depressive Episodes in Proximity to Adverse Respiratory Events During the PRODIGY Trial. PG - 738-741 LID - 10.1097/PTS.0000000000001003 [doi] AB - PURPOSE: The PRediction of Opioid-induced respiratory Depression In patients monitored by capnoGraphY (PRODIGY) trial was a multicenter prospective trial conducted to develop a risk prediction score for opioid-induced respiratory depressive (OIRD) episodes. Several subjects in the PRODIGY trial developed critical respiratory depressive events, which were qualified as reportable adverse events (AEs). In this study, we determine whether those patients also had an episode of OIRD as detected by continuous capnography and pulse oximetry leading up to the critical clinical event. METHODS: Blinded capnography and pulse oximetry data from PRODIGY patients who had critical respiratory depressive AE were reviewed. The occurrence and timing of OIRD episodes were recorded in relationship to the AE. RESULTS: Of the 1335 subjects in PRODIGY, 7 patients had 8 reportable pulmonary AE and 187 OIRDs (150 apnea episodes, 14 bradypnea episodes, 23 hypoxic episodes) with median 12 (5-19.5) OIRDs per patient. Five patients were monitored before the AE, and multiple preceding OIRD episodes were detected. One patient had 2 AE, the first (hypoxemia) was recognized upon application of pulse oximetry. This patient subsequently had multiple OIRDs until the second AE occurred (somnolence requiring naloxone administration). Another patient's AE (hypotension and bradypnea) was recognized upon monitor application and subsequently had many OIRD episodes. CONCLUSIONS: In the PRODIGY trial, patients who had a pulmonary AE had multiple preceding OIRDs detected by continuous capnography and pulse oximetry. When monitoring was initiated before the AE, numerous OIRDs, mostly apneic episodes preceded AE, suggesting continuous monitoring of both ventilation and oxygenation may allow for early detection and possible prediction of future clinical decompensation. CI - Copyright (c) 2022 The Author(s). Published by Wolters Kluwer Health, Inc. FAU - Kor, Jennifer J AU - Kor JJ AD - From the Kentucky College of Osteopathic Medicine, Pikeville, Kentucky. FAU - Sprung, Juraj AU - Sprung J AD - Departments of Anesthesiology and Perioperative Medicine, Mayo Clinic College of Medicine and Science, Rochester, Minnesota. FAU - Khanna, Ashish K AU - Khanna AK FAU - Weingarten, Toby N AU - Weingarten TN AD - Departments of Anesthesiology and Perioperative Medicine, Mayo Clinic College of Medicine and Science, Rochester, Minnesota. LA - eng SI - ClinicalTrials.gov/NCT02811302 PT - Journal Article PT - Multicenter Study PT - Research Support, Non-U.S. Gov't DEP - 20220427 PL - United States TA - J Patient Saf JT - Journal of patient safety JID - 101233393 RN - 0 (Analgesics, Opioid) SB - IM MH - Humans MH - *Analgesics, Opioid/adverse effects MH - Prospective Studies MH - *Capnography MH - Monitoring, Physiologic MH - Oximetry PMC - PMC9698081 COIS- T.N.W. has received consulting fees from Medtronic and Merck. A.K.K. has received consulting fees from Medtronic, Merck, and Edwards Lifesciences. The other authors disclose no conflict of interest. EDAT- 2022/04/12 06:00 MHDA- 2022/12/07 06:00 PMCR- 2022/11/25 CRDT- 2022/04/11 20:18 PHST- 2022/04/12 06:00 [pubmed] PHST- 2022/12/07 06:00 [medline] PHST- 2022/04/11 20:18 [entrez] PHST- 2022/11/25 00:00 [pmc-release] AID - 01209203-202212000-00002 [pii] AID - JPS_220200 [pii] AID - 10.1097/PTS.0000000000001003 [doi] PST - ppublish SO - J Patient Saf. 2022 Dec 1;18(8):738-741. doi: 10.1097/PTS.0000000000001003. Epub 2022 Apr 27.