Prediction of Opioid-Induced Respiratory Depression on Inpatient Wards Using Continuous Capnography and Oximetry: An International Prospective, Observational Trial.


Journal

Anesthesia and analgesia
ISSN: 1526-7598
Titre abrégé: Anesth Analg
Pays: United States
ID NLM: 1310650

Informations de publication

Date de publication:
10 2020
Historique:
entrez: 14 9 2020
pubmed: 15 9 2020
medline: 13 11 2020
Statut: ppublish

Résumé

Opioid-related adverse events are a serious problem in hospitalized patients. Little is known about patients who are likely to experience opioid-induced respiratory depression events on the general care floor and may benefit from improved monitoring and early intervention. The trial objective was to derive and validate a risk prediction tool for respiratory depression in patients receiving opioids, as detected by continuous pulse oximetry and capnography monitoring. PRediction of Opioid-induced respiratory Depression In patients monitored by capnoGraphY (PRODIGY) was a prospective, observational trial of blinded continuous capnography and oximetry conducted at 16 sites in the United States, Europe, and Asia. Vital signs were intermittently monitored per standard of care. A total of 1335 patients receiving parenteral opioids and continuously monitored on the general care floor were included in the analysis. A respiratory depression episode was defined as respiratory rate ≤5 breaths/min (bpm), oxygen saturation ≤85%, or end-tidal carbon dioxide ≤15 or ≥60 mm Hg for ≥3 minutes; apnea episode lasting >30 seconds; or any respiratory opioid-related adverse event. A risk prediction tool was derived using a multivariable logistic regression model of 46 a priori defined risk factors with stepwise selection and was internally validated by bootstrapping. One or more respiratory depression episodes were detected in 614 (46%) of 1335 general care floor patients (43% male; mean age, 58 ± 14 years) continuously monitored for a median of 24 hours (interquartile range [IQR], 17-26). A multivariable respiratory depression prediction model with area under the curve of 0.740 was developed using 5 independent variables: age ≥60 (in decades), sex, opioid naivety, sleep disorders, and chronic heart failure. The PRODIGY risk prediction tool showed significant separation between patients with and without respiratory depression (P < .001) and an odds ratio of 6.07 (95% confidence interval [CI], 4.44-8.30; P < .001) between the high- and low-risk groups. Compared to patients without respiratory depression episodes, mean hospital length of stay was 3 days longer in patients with ≥1 respiratory depression episode (10.5 ± 10.8 vs 7.7 ± 7.8 days; P < .0001) identified using continuous oximetry and capnography monitoring. A PRODIGY risk prediction model, derived from continuous oximetry and capnography, accurately predicts respiratory depression episodes in patients receiving opioids on the general care floor. Implementation of the PRODIGY score to determine the need for continuous monitoring may be a first step to reduce the incidence and consequences of respiratory compromise in patients receiving opioids on the general care floor.

Sections du résumé

BACKGROUND
Opioid-related adverse events are a serious problem in hospitalized patients. Little is known about patients who are likely to experience opioid-induced respiratory depression events on the general care floor and may benefit from improved monitoring and early intervention. The trial objective was to derive and validate a risk prediction tool for respiratory depression in patients receiving opioids, as detected by continuous pulse oximetry and capnography monitoring.
METHODS
PRediction of Opioid-induced respiratory Depression In patients monitored by capnoGraphY (PRODIGY) was a prospective, observational trial of blinded continuous capnography and oximetry conducted at 16 sites in the United States, Europe, and Asia. Vital signs were intermittently monitored per standard of care. A total of 1335 patients receiving parenteral opioids and continuously monitored on the general care floor were included in the analysis. A respiratory depression episode was defined as respiratory rate ≤5 breaths/min (bpm), oxygen saturation ≤85%, or end-tidal carbon dioxide ≤15 or ≥60 mm Hg for ≥3 minutes; apnea episode lasting >30 seconds; or any respiratory opioid-related adverse event. A risk prediction tool was derived using a multivariable logistic regression model of 46 a priori defined risk factors with stepwise selection and was internally validated by bootstrapping.
RESULTS
One or more respiratory depression episodes were detected in 614 (46%) of 1335 general care floor patients (43% male; mean age, 58 ± 14 years) continuously monitored for a median of 24 hours (interquartile range [IQR], 17-26). A multivariable respiratory depression prediction model with area under the curve of 0.740 was developed using 5 independent variables: age ≥60 (in decades), sex, opioid naivety, sleep disorders, and chronic heart failure. The PRODIGY risk prediction tool showed significant separation between patients with and without respiratory depression (P < .001) and an odds ratio of 6.07 (95% confidence interval [CI], 4.44-8.30; P < .001) between the high- and low-risk groups. Compared to patients without respiratory depression episodes, mean hospital length of stay was 3 days longer in patients with ≥1 respiratory depression episode (10.5 ± 10.8 vs 7.7 ± 7.8 days; P < .0001) identified using continuous oximetry and capnography monitoring.
CONCLUSIONS
A PRODIGY risk prediction model, derived from continuous oximetry and capnography, accurately predicts respiratory depression episodes in patients receiving opioids on the general care floor. Implementation of the PRODIGY score to determine the need for continuous monitoring may be a first step to reduce the incidence and consequences of respiratory compromise in patients receiving opioids on the general care floor.

Identifiants

pubmed: 32925318
doi: 10.1213/ANE.0000000000004788
pii: 00000539-202010000-00006
pmc: PMC7467153
doi:

Substances chimiques

Analgesics, Opioid 0

Banques de données

ClinicalTrials.gov
['NCT02811302']

Types de publication

Journal Article Multicenter Study Observational Study Research Support, Non-U.S. Gov't

Langues

eng

Sous-ensembles de citation

IM

Pagination

1012-1024

Investigateurs

Marianne Tanios (M)
Eva Rivas (E)
Miluska Mejia (M)
Kavita Elliott (K)
Assad Ali (A)
Juan Fiorda-Diaz (J)
Ruben Carrasco-Moyano (R)
Ana Mavarez-Martinez (A)
Alicia Gonzalez-Zacarias (A)
Cory Roeth (C)
January Kim (J)
Alan Esparza-Gutierrez (A)
Carleara Weiss (C)
Chiahui Chen (C)
Arata Taniguchi (A)
Yuko Mihara (Y)
Makiko Ariyoshi (M)
Ichiro Kondo (I)
Kentaro Yamakawa (K)
Yoshifumi Suga (Y)
Kohei Ikeda (K)
Koji Takano (K)
Yuuki Kuwabara (Y)
Nicole Carignan (N)
Joyce Rankin (J)
Katherine Egan (K)
Lakeisha Waters (L)
Ming Ann Sim (MA)
Lyn Li Lean (LL)
Qi En Lydia Liew (QEL)
Lawrence Siu-Chun Law (L)
James Gosnell (J)
Salina Shrestha (S)
Chisom Okponyia (C)
Mohammed H Al-Musawi (MH)
María José Parra Gonzalez (MJP)
Claudia Neumann (C)
Vera Guttenthaler (V)
Olja Männer (O)
Achilles Delis (A)
Anja Winkler (A)
Bahareh Marchand (B)
Frauke Schmal (F)
Fuad Aleskerov (F)
Mohammedumer Nagori (M)
Muhammad Shafi (M)
Gloria McPhee (G)
Cynthia Newman (C)
Elizabeth Lopez (E)
Sabrina Ma Har (SM)
Moumen Asbahi (M)
Kim Nordstrom McCaw (K)
Maurice Theunissen (M)
Valerie Smit-Fun (V)

Commentaires et corrections

Type : CommentIn
Type : CommentIn
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Type : CommentIn

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Auteurs

Ashish K Khanna (AK)

From the Department of Anesthesiology, Section on Critical Care Medicine, Wake Forest School of Medicine, Winston-Salem, North Carolina.
Outcomes Research Consortium, Cleveland, Ohio.

Sergio D Bergese (SD)

Department of Anesthesiology, The Ohio State University Medical Center, Columbus, Ohio.
Department of Anesthesiology, Stony Brook University School of Medicine, Stony Brook, New York.

Carla R Jungquist (CR)

University at Buffalo School of Nursing, Buffalo, New York.

Hiroshi Morimatsu (H)

Department of Anesthesiology and Resuscitology, Okayama University Hospital, Okayama, Japan.

Shoichi Uezono (S)

Jikei University School of Medicine, Tokyo, Japan.

Simon Lee (S)

Department of Anesthesiology, Emory University, Atlanta, Georgia.

Lian Kah Ti (LK)

Department of Anaesthesia, National University of Singapore, Singapore.

Richard D Urman (RD)

Department of Anesthesiology, Perioperative and Pain Medicine, Brigham and Women's Hospital, Boston, Massachusetts.

Robert McIntyre (R)

Department of Surgery, University of Colorado School of Medicine, Aurora, Colorado.

Carlos Tornero (C)

Department of Anesthesiology, Resuscitation and Pain Therapeutics, Hospital Clinico Universitario de Valencia, Valencia, Spain.

Albert Dahan (A)

Department of Anesthesiology, Leiden University Medical Center, Leiden, the Netherlands.

Leif Saager (L)

Department of Anesthesiology, University of Michigan Medical School, Ann Arbor, Michigan.
Klinik für Anästhesiologie, Universitätsmedizin Göttingen, Göttingen, Germany.

Toby N Weingarten (TN)

Department of Anesthesiology and Perioperative Medicine, Mayo Clinic, Rochester, Minnesota.

Maria Wittmann (M)

Department of Anaesthesiology, University Hospital Bonn, Bonn, Germany.

Dennis Auckley (D)

Division of Pulmonary, Critical Care, and Sleep Medicine, MetroHealth Medical Center, Case Western Reserve University, Cleveland, Ohio.

Luca Brazzi (L)

Department of Anesthesia, Intensive Care and Emergency, University of Turin, Turin, Italy.

Morgan Le Guen (M)

Department of Anaesthesiology, Hôpital Foch, Suresnes, France.

Roy Soto (R)

Department of Anesthesiology, Beaumont Hospital, Royal Oak, Michigan.

Frank Schramm (F)

Department of Anesthesiology, Providence Regional Medical Center, Everett, Washington.

Sabry Ayad (S)

Cleveland Clinic Foundation, Outcomes Research Consortium, Cleveland, Ohio.

Roop Kaw (R)

Cleveland Clinic Foundation, Outcomes Research Consortium, Cleveland, Ohio.

Paola Di Stefano (P)

Medtronic Core Clinical Solutions, Study and Scientific Solutions, Rome, Italy.

Daniel I Sessler (DI)

Department of Outcomes Research, Anesthesiology Institute, Cleveland Clinic, Cleveland, Ohio.

Alberto Uribe (A)

Department of Anesthesiology, The Ohio State University Medical Center, Columbus, Ohio.

Vanessa Moll (V)

Department of Anesthesiology, Emory University, Atlanta, Georgia.

Susan J Dempsey (SJ)

Department of Surgery, University of Colorado School of Medicine, Aurora, Colorado.
University of California, Los Angeles, School of Nursing, Los Angeles, California.

Wolfgang Buhre (W)

Department of Anesthesiology, University Medical Center, Maastricht, the Netherlands.

Frank J Overdyk (FJ)

Trident Anesthesia Group, LLC, Charleston, South Carolina.

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