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3. Design of Clinical Trials Evaluating Sedation in Critically Ill Adults Undergoing Mechanical Ventilation: Recommendations From Sedation Consortium on Endpoints and Procedures for Treatment, Education, and Research (SCEPTER) Recommendation III

Author

Ward, Denham S, Absalom, Anthony R, Aitken, Leanne M, Balas, Michele C, Brown, David L, Burry, Lisa, Colantuoni, Elizabeth, Coursin, Douglas, Devlin, John W, Dexter, Franklin, Dworkin, Robert H, Egan, Talmage D, Elliott, Doug, Egerod, Ingrid, Flood, Pamela, Fraser, Gilles L, Girard, Timothy D, Gozal, David, Hopkins, Ramona O, Kress, John, Maze, Mervyn, Needham, Dale M, Pandharipande, Pratik, Riker, Richard, Sessler, Daniel I, Shafer, Steven L, Shehabi, Yahya, Spies, Claudia, Sun, Lena S, Tung, Avery, and Urman, Richard D

Subjects
Biomedical and Clinical Sciences, Clinical Sciences, Prevention, Clinical Trials and Supportive Activities, Clinical Research, Patient Safety, Generic health relevance, Quality Education, Congresses as Topic, Consensus, Delphi Technique, District of Columbia, Humans, Hypnotics and Sedatives, Respiration, Artificial, Time Factors, clinical trial, intensive care, outcome assessments, research methodology, sedation, Nursing, Public Health and Health Services, Emergency & Critical Care Medicine, Clinical sciences
Abstract

ObjectivesClinical trials evaluating the safety and effectiveness of sedative medication use in critically ill adults undergoing mechanical ventilation differ considerably in their methodological approach. This heterogeneity impedes the ability to compare results across studies. The Sedation Consortium on Endpoints and Procedures for Treatment, Education, and Research Recommendations convened a meeting of multidisciplinary experts to develop recommendations for key methodologic elements of sedation trials in the ICU to help guide academic and industry clinical investigators.DesignA 2-day in-person meeting was held in Washington, DC, on March 28-29, 2019, followed by a three-round, online modified Delphi consensus process.ParticipantsThirty-six participants from academia, industry, and the Food and Drug Administration with expertise in relevant content areas, including two former ICU patients attended the in-person meeting, and the majority completed an online follow-up survey and participated in the modified Delphi process.Measurements and main resultsThe final recommendations were iteratively refined based on the survey results, participants' reactions to those results, summaries written by panel moderators, and a review of the meeting transcripts made from audio recordings. Fifteen recommendations were developed for study design and conduct, subject enrollment, outcomes, and measurement instruments. Consensus recommendations included obtaining input from ICU survivors and/or their families, ensuring adequate training for personnel using validated instruments for assessments of sedation, pain, and delirium in the ICU environment, and the need for methodological standardization.ConclusionsThese recommendations are intended to assist researchers in the design, conduct, selection of endpoints, and reporting of clinical trials involving sedative medications and/or sedation protocols for adult ICU patients who require mechanical ventilation. These recommendations should be viewed as a starting point to improve clinical trials and help reduce methodological heterogeneity in future clinical trials.

Published
2021

15. International Analgesia and Sedation Weaning and Withdrawal Practices in Critically Ill Adults: The Adult Iatrogenic Withdrawal Study in the ICU*

Author

Bolesta, Scott, Burry, Lisa, Perreault, Marc M., Gélinas, Céline, Smith, Kathryn E., Eadie, Rebekah, Carini, Federico C., Saltarelli, Katrianna, Mitchell, Jennifer, Harpel, Jamie, Stewart, Ryan, Riker, Richard R., Fraser, Gilles L., Erstad, Brian L., Alcántara, Sara, Aldardeer, Namareq, Alhammad, Abdullah, Almohaish, Sulaiman, Ammar, Mahmoud, Arroyo-Novoa, Carmen Mabel, Awassi, Don-Kelena, Badano, Mariana, Badman, Belinda, Barnes, Sanchia, Bertozzi, Matias, Botros, Shady, Brophy, Gretchen, Brown, Caitlin, Brown, Glen, Buckley, Mitchell, Burgess, Sarah, Campbell, Joshua, Carothers, Chancey, Celario, Patricio, Chambers, Lauren, Chanques, Gérald, Contreras, Sofia, d’Hebron, Vall, Cortes, Jennifer, Cozzi, Gabrielle, Cucci, Michaelia, Cunto, Eleonora, Dao, Denis, Defayette, Aubrey, Dey, Alexandra, Diaz, Anatilde, Dixit, Deepali, Dube, Jean-Noel, Duceppe, Marc-Alexandre, Dzierba, Amy, Farrell, Odran, Ferranti, Pietro, Flannery, Alexander, Fontaine, Gabriel, Forehand, Christy, Nelson, Nydia Funes, Gillet, Manon, Gonzalez, Gustavo Nicolas, Graham-Clarke, Emma, Green, Sarah, Groth, Christine, Hamid, Hytham, Hamilton, Leslie, Hanley, Joanne, Jackson, Jessica, Johnston, Jackie, Kanji, Salmaan, Katzman, Sam, Kenes, Michael, Kinney, Justin, Kohler, Claire, Kovacic, Nicole, Kuroski, Julia, Landolf, Kaitlin, Laotheerachao, Rosalynn, Largana, Samuel, Lebrun, Genevieve, Leonardo, Kate, Levins, Elizabeth, Lewis-Wolfson, Temeka, Mailman, Jonathan, Man, Anna, Mandich, Veronica, McCullagh, Iain, McDonald, Jill, Gil, Antonella Milano, Ng, Wing Sum (Winny), Nguyen, Hang, O’Hare, Madeline, saleh, Jesus eduardo Ochoa, Oswald, Christopher, Patanwala, Asad, Payen, Jean-Francois, Phan, Brian, Radosevich, John, Reiter, Tamara, Remmington, Christopher, Reyes, Viviana, Roberts, Russel, Sagardia, Judith, Sall, Jas, Sanchez, Diego, Shoulders, Bethany, Sneyers, Barbara, Thiboutot, Zoe, Thompson, Melissa, Timmins, Alan, Tolosa, Carina Fernanda, Tolosa, Carina, Junin, Sanatorio, Torres, Valentin Gabriel, Tran, Sandy, Trinh, Thu Ha, Tynan, Sinead, Vu, Lan, Wilson, Franki, Cook, Aaron, Ciolek, Alana, Haines, Aleina, Rodriguez, Alejandra, Cheung, Alexandra, Leong, Amanda, Nisnik, Ana Laura, Mancilla, Ana Maria, Rinehimer, Brandon, Sloan, Brett, Bissell, Brittany, Kulilg, Caitlin, Coombe, Cassandra, Dominguez, Cecilia, Wampole, Chelsea, Rodriguez de la Quintana, Cristhian, Mulodjanov, Darina, Tsoller, Darina, Bowen, David, Gagnon, David, Purkayastha, Debanjali, Ali, Dina, Saidahmed, Elfayadh, Lewandowski, Emily, Schranz, Emily, MacNeil, Erin, Hanks, Fraser, Kassab, Hager, Brokmeier, Hannah, Kaur, Jaspreet, Huntress, Jeff, Clark, Jenna, Falvey, Jennifer, De Giacomo, Jessica, Smith, Jonathan, Ibarzabal, Juan, Niland, Judith, Muir, Justin, Gosek, Kasia, Maynard, Kaylee, Kooda, Kirstin, Pandya, Komal, Kaupp, Kristin, Ebitt, Laura, Bordon, Lucas, Chiscano, Lusi, Sosa, Manuel, Cosep, Marc, Lobo, Marcelo, Monte, Marco Flores, Sandler, Melissa, Bastin, Melissa Thompson, Armahizer, Michael, Wang, Michelle, Eshaghian, Miriam, Rizwan, Mohammad, Patel, Mona, Pistillo, Nestor, Harris, Nicole, Torella, Pau, Phongsamran, Paula, Woo, Priscilla, Garcia, Rhiannon, Sabelli, Rosana Gregori, Grant, Ryan, Delibert, Samantha, Parli, Sara, Wilson, Sharon, Yeung, Siu Yan Amy, Putruele, Sofia, Rappaport, Stephen, Welch, Susan, Moitra, Vivek, and Chediack, Viviana

Published
2023
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16. Executive Summary

Author

Devlin, John W, Skrobik, Yoanna, Gélinas, Céline, Needham, Dale M, Slooter, Arjen JC, Pandharipande, Pratik P, Watson, Paula L, Weinhouse, Gerald L, Nunnally, Mark E, Rochwerg, Bram, Balas, Michele C, van den Boogaard, Mark, Bosma, Karen J, Brummel, Nathaniel E, Chanques, Gerald, Denehy, Linda, Drouot, Xavier, Fraser, Gilles L, Harris, Jocelyn E, Joffe, Aaron M, Kho, Michelle E, Kress, John P, Lanphere, Julie A, McKinley, Sharon, Neufeld, Karin J, Pisani, Margaret A, Payen, Jean-Francois, Pun, Brenda T, Puntillo, Kathleen A, Riker, Richard R, Robinson, Bryce RH, Shehabi, Yahya, Szumita, Paul M, Winkelman, Chris, Centofanti, John E, Price, Carrie, Nikayin, Sina, Misak, Cheryl J, Flood, Pamela D, Kiedrowski, Ken, and Alhazzani, Waleed

Subjects
Biomedical and Clinical Sciences, Nursing, Clinical Sciences, Health Sciences, Adult, Conscious Sedation, Critical Care, Deep Sedation, Delirium, Humans, Intensive Care Units, Pain, Pain Management, Psychomotor Agitation, Restraint, Physical, Sleep Wake Disorders, delirium, guidelines, intensive care, mobilization, pain, sedation, sleep, Public Health and Health Services, Emergency & Critical Care Medicine, Clinical sciences
Published
2018

17. Executive Summary: Clinical Practice Guidelines for the Prevention and Management of Pain, Agitation/Sedation, Delirium, Immobility, and Sleep Disruption in Adult Patients in the ICU.

Author

Devlin, John W, Skrobik, Yoanna, Gélinas, Céline, Needham, Dale M, Slooter, Arjen JC, Pandharipande, Pratik P, Watson, Paula L, Weinhouse, Gerald L, Nunnally, Mark E, Rochwerg, Bram, Balas, Michele C, van den Boogaard, Mark, Bosma, Karen J, Brummel, Nathaniel E, Chanques, Gerald, Denehy, Linda, Drouot, Xavier, Fraser, Gilles L, Harris, Jocelyn E, Joffe, Aaron M, Kho, Michelle E, Kress, John P, Lanphere, Julie A, McKinley, Sharon, Neufeld, Karin J, Pisani, Margaret A, Payen, Jean-Francois, Pun, Brenda T, Puntillo, Kathleen A, Riker, Richard R, Robinson, Bryce RH, Shehabi, Yahya, Szumita, Paul M, Winkelman, Chris, Centofanti, John E, Price, Carrie, Nikayin, Sina, Misak, Cheryl J, Flood, Pamela D, Kiedrowski, Ken, and Alhazzani, Waleed

Subjects
Humans, Psychomotor Agitation, Delirium, Pain, Restraint, Physical, Critical Care, Conscious Sedation, Adult, Intensive Care Units, Deep Sedation, Pain Management, Sleep Wake Disorders, delirium, guidelines, intensive care, mobilization, pain, sedation, sleep, Emergency & Critical Care Medicine, Clinical Sciences, Nursing, Public Health and Health Services
Published
2018

18. Clinical Practice Guidelines for the Prevention and Management of Pain, Agitation/Sedation, Delirium, Immobility, and Sleep Disruption in Adult Patients in the ICU.

Author

Devlin, John W, Skrobik, Yoanna, Gélinas, Céline, Needham, Dale M, Slooter, Arjen JC, Pandharipande, Pratik P, Watson, Paula L, Weinhouse, Gerald L, Nunnally, Mark E, Rochwerg, Bram, Balas, Michele C, van den Boogaard, Mark, Bosma, Karen J, Brummel, Nathaniel E, Chanques, Gerald, Denehy, Linda, Drouot, Xavier, Fraser, Gilles L, Harris, Jocelyn E, Joffe, Aaron M, Kho, Michelle E, Kress, John P, Lanphere, Julie A, McKinley, Sharon, Neufeld, Karin J, Pisani, Margaret A, Payen, Jean-Francois, Pun, Brenda T, Puntillo, Kathleen A, Riker, Richard R, Robinson, Bryce RH, Shehabi, Yahya, Szumita, Paul M, Winkelman, Chris, Centofanti, John E, Price, Carrie, Nikayin, Sina, Misak, Cheryl J, Flood, Pamela D, Kiedrowski, Ken, and Alhazzani, Waleed

Subjects
Humans, Psychomotor Agitation, Delirium, Pain, Restraint, Physical, Critical Care, Conscious Sedation, Intensive Care Units, Deep Sedation, Pain Management, Sleep Wake Disorders, delirium, guidelines, immobility, intensive care, mobilization, pain, sedation, sleep, Restraint, Physical, Emergency & Critical Care Medicine, Clinical Sciences, Nursing, Public Health and Health Services
Abstract

OBJECTIVE:To update and expand the 2013 Clinical Practice Guidelines for the Management of Pain, Agitation, and Delirium in Adult Patients in the ICU. DESIGN:Thirty-two international experts, four methodologists, and four critical illness survivors met virtually at least monthly. All section groups gathered face-to-face at annual Society of Critical Care Medicine congresses; virtual connections included those unable to attend. A formal conflict of interest policy was developed a priori and enforced throughout the process. Teleconferences and electronic discussions among subgroups and whole panel were part of the guidelines' development. A general content review was completed face-to-face by all panel members in January 2017. METHODS:Content experts, methodologists, and ICU survivors were represented in each of the five sections of the guidelines: Pain, Agitation/sedation, Delirium, Immobility (mobilization/rehabilitation), and Sleep (disruption). Each section created Population, Intervention, Comparison, and Outcome, and nonactionable, descriptive questions based on perceived clinical relevance. The guideline group then voted their ranking, and patients prioritized their importance. For each Population, Intervention, Comparison, and Outcome question, sections searched the best available evidence, determined its quality, and formulated recommendations as "strong," "conditional," or "good" practice statements based on Grading of Recommendations Assessment, Development and Evaluation principles. In addition, evidence gaps and clinical caveats were explicitly identified. RESULTS:The Pain, Agitation/Sedation, Delirium, Immobility (mobilization/rehabilitation), and Sleep (disruption) panel issued 37 recommendations (three strong and 34 conditional), two good practice statements, and 32 ungraded, nonactionable statements. Three questions from the patient-centered prioritized question list remained without recommendation. CONCLUSIONS:We found substantial agreement among a large, interdisciplinary cohort of international experts regarding evidence supporting recommendations, and the remaining literature gaps in the assessment, prevention, and treatment of Pain, Agitation/sedation, Delirium, Immobility (mobilization/rehabilitation), and Sleep (disruption) in critically ill adults. Highlighting this evidence and the research needs will improve Pain, Agitation/sedation, Delirium, Immobility (mobilization/rehabilitation), and Sleep (disruption) management and provide the foundation for improved outcomes and science in this vulnerable population.

Published
2018

19. Ceftriaxone to PRevent pneumOnia and inflammaTion aftEr Cardiac arresT (PROTECT): study protocol for a randomized, placebo-controlled trial

Author

Gagnon, David J., Ryzhov, Sergey V., May, Meghan A., Riker, Richard R., Geller, Bram, May, Teresa L., Bockian, Sarah, deKay, Joanne T., Eldridge, Ashley, Van der Kloot, Thomas, Lerwick, Patricia, Lord, Christine, Lucas, F. Lee, Mailloux, Patrick, McCrum, Barbara, Searight, Meghan, Wirth, Joel, Zuckerman, Jonathan, Sawyer, Douglas, and Seder, David B.

Published
2022
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20. Incidence of cardiac interventions and associated cardiac arrest outcomes in patients with nonshockable initial rhythms and no ST elevation post resuscitation

Author

Harhash, Ahmed A., May, Teresa, Hsu, Chiu-Hsieh, Seder, David B., Dankiewicz, Josef, Agarwal, Sachin, Patel, Nainesh, McPherson, John, Riker, Richard, Soreide, Eldar, Hirsch, Karen G., Stammet, Pascal, Dupont, Allison, Forsberg, Sune, Rubertsson, Sten, Friberg, Hans, Nielsen, Niklas, Mooney, Michael R., and Kern, Karl B.

Published
2021
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21. Influence of sex on survival, neurologic outcomes, and neurodiagnostic testing after out-of-hospital cardiac arrest

Author

Vogelsong, Melissa A., May, Teresa, Agarwal, Sachin, Cronberg, Tobias, Dankiewicz, Josef, Dupont, Allison, Friberg, Hans, Hand, Robert, McPherson, John, Mlynash, Michael, Mooney, Michael, Nielsen, Niklas, O'Riordan, Andrea, Patel, Nainesh, Riker, Richard R., Seder, David B., Soreide, Eldar, Stammet, Pascal, Xiong, Wei, and Hirsch, Karen G.

Published
2021
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24. Functional outcomes associated with varying levels of targeted temperature management after out-of-hospital cardiac arrest — An INTCAR2 registry analysis

Author

Johnsson, Jesper, Wahlström, Josefine, Dankiewicz, Josef, Annborn, Martin, Agarwal, Sachin, Dupont, Allison, Forsberg, Sune, Friberg, Hans, Hand, Robert, Hirsch, Karen G., May, Teresa, McPherson, John A., Mooney, Michael R, Patel, Nainesh, Riker, Richard R., Stammet, Pascal, Søreide, Eldar, Seder, David B., and Nielsen, Niklas

Published
2020
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37. Variability in functional outcome and treatment practices by treatment center after out-of-hospital cardiac arrest: analysis of International Cardiac Arrest Registry

Author

May, Teresa L., Lary, Christine W., Riker, Richard R., Friberg, Hans, Patel, Nainesh, Søreide, Eldar, and McPherson, John A.

Subjects
Medical colleges -- Analysis, Cardiac arrest -- Patient outcomes, Transluminal angioplasty -- Analysis, Health care industry
Abstract

Purpose Functional outcomes vary between centers after out-of-hospital cardiac arrest (OHCA) and are partially explained by pre-existing health status and arrest characteristics, while the effects of in-hospital treatments on functional outcome are less understood. We examined variation in functional outcomes by center after adjusting for patient- and arrest-specific characteristics and evaluated how in-hospital management differs between high- and low-performing centers. Methods Analysis of observational registry data within the International Cardiac Arrest Registry was used to perform a hierarchical model of center-specific risk standardized rates for good outcome, adjusted for demographics, pre-existing functional status, and arrest-related factors with treatment center as a random effect variable. We described the variability in treatments and diagnostic tests that may influence outcome at centers with adjusted rates significantly above and below registry average. Results A total of 3855 patients were admitted to an ICU following cardiac arrest with return of spontaneous circulation. The overall prevalence of good outcome was 11-63% among centers. After adjustment, center-specific risk standardized rates for good functional outcome ranged from 0.47 (0.37-0.58) to 0.20 (0.12-0.26). High-performing centers had faster time to goal temperature, were more likely to have goal temperature of 33 °C, more likely to perform unconscious cardiac catheterization and percutaneous coronary intervention, and had differing prognostication practices than low-performing centers. Conclusions Center-specific differences in outcomes after OHCA after adjusting for patient-specific factors exist. This variation could partially be explained by in-hospital management differences. Future research should address the contribution of these factors to the differences in outcomes after resuscitation., Author(s): Teresa L. May [sup.1] [sup.2], Christine W. Lary [sup.3], Richard R. Riker [sup.1], Hans Friberg [sup.4], Nainesh Patel [sup.5], Eldar Søreide [sup.6] [sup.7], John A. McPherson [sup.8], Johan Undén [...]

Published
2019
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39. NEURO-RESPIRATORY ETIOLOGY OF CARDIAC ARREST IS ASSOCIATED WITH SUBSEQUENT DEVELOPMENT OF EARLY-ONSET PNEUMONIA

Author

MICHALAKES, PETER C, primary, SORCHER, MARY, additional, RIKER, RICHARD, additional, MAY, TERESA L, additional, LORD, CHRISTINE, additional, SEARIGHT, MEGHAN, additional, DALEY, ALISON, additional, BOCKIAN, SARAH, additional, WEISSMAN, ALEXANDRA, additional, DEKAY, JOANNE, additional, WISHENGRAD, JEANNE, additional, RYZHOV, SERGEY, additional, SEDER, DAVID B, additional, and GAGNON, DAVID, additional

Published
2023
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44. The association of partial pressures of oxygen and carbon dioxide with neurological outcome after out-of-hospital cardiac arrest: an explorative International Cardiac Arrest Registry 2.0 study

Author

Ebner, Florian, Riker, Richard R., Haxhija, Zana, Seder, David B., May, Teresa L., Ullén, Susann, Stammet, Pascal, Hirsch, Karen, Forsberg, Sune, Dupont, Allison, Friberg, Hans, McPherson, John A., Søreide, Eldar, Dankiewicz, Josef, Cronberg, Tobias, and Nielsen, Niklas

Published
2020
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