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

Ward, Denham S.; Absalom, Anthony; Aitken, Leanne M.; Balas, Michele C.; Brown, David; Burry, Lisa; Colantuoni, Elizabeth; Coursin, Douglas B.; 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 P.; Maze, Mervyn; Pandharipande, Pratik; Riker, Richard R.; Sessler, Daniel I.; Shafer, Steven L.; Shehabi, Yahya; Spies, Claudia; Sun, Lena S.; Tung, Avery; Urman, Richard D.

doi:10.1097/ccm.0000000000005049

Cited by 16 publications

(9 citation statements)

References 43 publications

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“…9 Assessment methods utilized to assess whether the sedation target has been achieved may be impacted by the choice of sedation scales, and therefore, require careful consideration before selection. 14 It is important that assessment, whether performed by study personnel or nursing staff, is accurate, reproducible, and complete; therefore, education is an instrumental part of ensuring their successful execution. 14 Pediatric trials have been particularly challenged by issues related to inclusion and exclusion criteria.…”

Section: Challenges Of Clinical Trial Design and Conductmentioning

confidence: 99%

“…14 It is important that assessment, whether performed by study personnel or nursing staff, is accurate, reproducible, and complete; therefore, education is an instrumental part of ensuring their successful execution. 14 Pediatric trials have been particularly challenged by issues related to inclusion and exclusion criteria. 3 As mentioned earlier, age-related factors which are unique to the pediatric population create tremendous variations in terms of development, cognition, behavioral adaptations, and organ development.…”

Section: Challenges Of Clinical Trial Design and Conductmentioning

confidence: 99%

“…At present, clinical trials have focused mostly on examining in-hospital outcomes. Consideration should be given to the full recovery and patient-centered outcomes (eg, general health, functional, cognitive, and behavioral domains), which are vital to gain a more complete understanding of PICU survivors and their overall life trajectory 14…”

Section: Picu Sedation Trials and The Road Less Traveledmentioning

confidence: 99%

See 2 more Smart Citations

Pediatric Intensive Care Unit Patients: Sedation, Monitoring, and Neurodevelopmental Outcomes

Lee¹,

Jaconia²,

Sun

et al. 2022

Journal of Neurosurgical Anesthesiology

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The design and conduct of pediatric sedation studies in critically ill patients have historically been challenging due to the complexity of the pediatric intensive care unit (PICU) environment and the difficulty of establishing equipoise. Clinical trials, for instance, represent 1 important means of advancing our knowledge in this field, but there is a paucity of such studies in the literature. Accounting for ground-level factors in planning for each trial phase (eg, enrollment, intervention, assessment, and follow-up) and the presence of broader system limitations is of key importance. In addition, there is a need for early planning, coordination, and obtaining buy-in from individual study sites and staff to ensure success, particularly for multicenter studies. This review synthesizes the current state of pediatric sedation research and the myriad of challenges in designing and conducting successful trials in this particular area. The review poses consideration for future research directions, including novel study designs, and discusses electroencephalography monitoring and neurodevelopmental outcomes of PICU survivors.

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Section: Challenges Of Clinical Trial Design and Conductmentioning

confidence: 99%

Section: Challenges Of Clinical Trial Design and Conductmentioning

confidence: 99%

Section: Picu Sedation Trials and The Road Less Traveledmentioning

confidence: 99%

See 1 more Smart Citation

Pediatric Intensive Care Unit Patients: Sedation, Monitoring, and Neurodevelopmental Outcomes

Lee¹,

Jaconia²,

Sun

et al. 2022

Journal of Neurosurgical Anesthesiology

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View full text Add to dashboard Cite

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“…SCEPTER is part of the Analgesic, Anesthetic, Addiction Clinical Trial Translations, Innovations, Opportunities, and Networks (ACTTION), which is a U.S. public-private partnership in collaboration with the Food and Drug Administration (FDA) (6). During 2017-2021, SCEPTER worked on the design of clinical trials: 1) for procedural sedation in adults and children, including a focus on efficacy and safety; 2) ICU sedation and analgesia in adults; and 3) a scoping review of analgesia and sedation in the PICU population (7)(8)(9)(10). The goal of the SCEPTER IV meetings were to develop an evidence-based and pragmatic set of statements about analgosedation (i.e., sedation and analgesia) in patients requiring mechanical ventilation in the PICU.…”

mentioning

confidence: 99%

Sedation Research in Critically Ill Pediatric Patients: Proposals for Future Study Design From the Sedation Consortium on Endpoints and Procedures for Treatment, Education, and Research IV Workshop

Jackson,

Lee,

Jackson

et al. 2023

Pediatric Critical Care Medicine

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OBJECTIVES: Sedation and analgesia for infants and children requiring mechanical ventilation in the PICU is uniquely challenging due to the wide spectrum of ages, developmental stages, and pathophysiological processes encountered. Studies evaluating the safety and efficacy of sedative and analgesic management in pediatric patients have used heterogeneous methodologies. The Sedation Consortium on Endpoints and Procedures for Treatment, Education, and Research (SCEPTER) IV hosted a series of multidisciplinary meetings to establish consensus statements for future clinical study design and implementation as a guide for investigators studying PICU sedation and analgesia. DESIGN: Twenty-five key elements framed as consensus statements were developed in five domains: study design, enrollment, protocol, outcomes and measurement instruments, and future directions. SETTING: A virtual meeting was held on March 2–3, 2022, followed by an in-person meeting in Washington, DC, on June 15–16, 2022. Subsequent iterative online meetings were held to achieve consensus. SUBJECTS: Fifty-one multidisciplinary, international participants from academia, industry, the U.S. Food and Drug Administration, and family members of PICU patients attended the virtual and in-person meetings. Participants were invited based on their background and experience. INTERVENTIONS: None. MEASUREMENTS AND MAIN RESULTS: Common themes throughout the SCEPTER IV consensus statements included using coordinated multidisciplinary and interprofessional teams to ensure culturally appropriate study design and diverse patient enrollment, obtaining input from PICU survivors and their families, engaging community members, and using developmentally appropriate and validated instruments for assessments of sedation, pain, iatrogenic withdrawal, and ICU delirium. CONCLUSIONS: These SCEPTER IV consensus statements are comprehensive and may assist investigators in the design, enrollment, implementation, and dissemination of studies involving sedation and analgesia of PICU patients requiring mechanical ventilation. Implementation may strengthen the rigor and reproducibility of research studies on PICU sedation and analgesia and facilitate the synthesis of evidence across studies to improve the safety and quality of care for PICU patients.

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“…High quality evidence is lacking in sedation research secondary to heterogeneity of data and resistance to practice change. Future directions include using a standardized approach allowing for meaningful comparisons between studies [14]. Additionally, use of inhaled anesthetics for sedation of critically ill patients is promising [15].…”

mentioning

confidence: 99%

Evolution of sedation management in the intensive care unit (ICU)

2022

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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

Abstract: Supplemental Digital Content is available in the text.

Cited by 16 publications

References 43 publications

Pediatric Intensive Care Unit Patients: Sedation, Monitoring, and Neurodevelopmental Outcomes

Pediatric Intensive Care Unit Patients: Sedation, Monitoring, and Neurodevelopmental Outcomes

Sedation Research in Critically Ill Pediatric Patients: Proposals for Future Study Design From the Sedation Consortium on Endpoints and Procedures for Treatment, Education, and Research IV Workshop

Evolution of sedation management in the intensive care unit (ICU)

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