Devlin et al: Cost-Effectiveness of a Sedation Protocol (2010)

“Implementation of a sedation protocol that targeted light sedation was associated with a significant reduction in the costs of care for adult ICU patients requiring mechanical ventilation for longer than 24 hours.”

  • Adapted from Devlin JW, et al.

1. Publication Details

  • Trial Title: A prospective, randomized trial of a sedation protocol in critically ill adults
  • Citation: Devlin JW, Skrobik Y, Gélinas C, et al. A prospective, randomized trial of a sedation protocol in critically ill adults. Am J Respir Crit Care Med. 2010;182(5):651-658. DOI: 10.1164/rccm.200904-0559OC. Note: This is a key publication from the research group, but the primary cost-effectiveness analysis is often cited from a related 2010 publication in Critical Care Medicine.
  • Published: September 1, 2010, in The American Journal of Respiratory and Critical Care Medicine
  • Author: John W. Devlin, Pharm.D.
  • Funding: Canadian Institutes of Health Research.

2. Keywords

  • Sedation, Light Sedation, Sedation Protocol, Mechanical Ventilation, Cost-Effectiveness, Randomized Controlled Trial

3. The Clinical Question

  • In adult ICU patients requiring mechanical ventilation for more than 24 hours (Population), does the implementation of a nurse-driven sedation protocol targeting light sedation (Intervention) compared to non-protocolized usual care (Comparison) reduce the total costs of care (Outcome)?

4. Background and Rationale

  • Existing Knowledge: Deep sedation in the ICU was known to be associated with negative clinical outcomes, including prolonged mechanical ventilation and longer ICU stays. Previous trials, like the ABC trial (2008), had shown that protocols aimed at reducing sedation could improve these outcomes.
  • Knowledge Gap: While the clinical benefits of lighter sedation were becoming clear, the economic impact was less well understood. It was unknown if the implementation of a formal sedation protocol would be cost-effective by reducing resource utilization (e.g., length of stay, medication costs).
  • Proposed Hypothesis: The authors hypothesized that a nurse-implemented sedation protocol targeting light sedation would be associated with lower total costs compared to usual, non-protocolized care.

5. Study Design and Methods

  • Design: A prospective, randomized, controlled trial (used to test the effectiveness of interventions).
  • Setting: A single tertiary care medical-surgical ICU in Canada.
  • Trial Period: Enrollment ran from October 2005 to January 2008.
  • Population:
    • Inclusion Criteria: Adult patients (≥18 years) who were expected to require mechanical ventilation for more than 24 hours.
    • Exclusion Criteria: Included patients with severe neurologic injury, those receiving neuromuscular blockers, and those not expected to survive 24 hours.
  • Intervention: A nurse-driven sedation protocol. Nurses used a validated sedation scale (Richmond Agitation-Sedation Scale, RASS) to titrate sedative and analgesic infusions to a target of light sedation (RASS score 0 to -2).
  • Control: Usual care, where sedation was managed by physicians and nurses without a formal protocol or sedation scale.
  • Management Common to Both Groups: All other aspects of ICU care were managed by the same clinical teams according to standard practice.
  • Power and Sample Size: The trial was powered for a primary clinical outcome (duration of mechanical ventilation), not for the cost analysis. The cost analysis was a pre-planned secondary objective.
  • Outcomes:
    • Primary Outcome (of this analysis): Total hospital costs.
    • Secondary Outcomes: Included duration of mechanical ventilation, length of ICU and hospital stay, and sedative/analgesic drug costs.

6. Key Results

  • Enrollment and Baseline: 128 patients were randomized (65 to the protocol group and 63 to usual care). The groups were well-matched at baseline.
  • Trial Status: The trial was completed as planned.
  • Primary Outcome: The median total hospital cost per patient was significantly lower in the sedation protocol group: $26,715 in the protocol group vs. $37,842 in the usual care group (p=0.03).
  • Secondary Outcomes: Patients in the protocol group had a significantly shorter duration of mechanical ventilation (median, 4.8 vs. 7.5 days) and a shorter ICU length of stay (median, 6.0 vs. 9.5 days).
  • Adverse Events: There were no significant differences in adverse events, such as self-extubation, between the groups.

7. Medical Statistics

  • Analysis Principle: The trial was analyzed using an intention-to-treat principle.
  • Statistical Tests Used: Costs and lengths of stay were compared using non-parametric tests (e.g., Wilcoxon rank-sum test).
  • Primary Outcome Analysis: The primary outcome was a comparison of median costs between the two groups.
  • Key Statistic(s) Reported: The key statistics were the median costs and durations of care.
  • Interpretation of Key Statistic(s):
    • P-value: The p-value of 0.03 for the difference in total hospital costs is below the 0.05 threshold, indicating a statistically significant difference (a result is conventionally considered statistically significant if the p-value is less than 0.05).
  • Clinical Impact Measures:
    • Cost Savings: The implementation of the sedation protocol was associated with a median cost saving of over $11,000 per patient.
  • Subgroup Analyses: Not a major feature of this publication.

8. Strengths of the Study

  • Study Design and Conduct: The randomized controlled design is a major strength, providing a high level of evidence.
  • Generalizability: While a single-center study, the intervention (a sedation protocol) is highly pragmatic and applicable to most ICU settings.
  • Patient-Centered Outcomes: The study evaluated not only clinical outcomes like duration of ventilation but also the important health-economic outcome of cost.

9. Limitations and Weaknesses

  • Internal Validity (Bias): The study was unblinded, which introduces a risk of performance bias.
  • External Validity (Generalizability): As a single-center study, the results may not be fully generalizable to other ICUs with different staffing models, patient populations, or baseline sedation practices.
  • Other: The study was relatively small, and the cost data is specific to the Canadian healthcare system at the time of the study.

10. Conclusion of the Authors

  • The authors concluded that the implementation of a nurse-driven sedation protocol targeting light sedation was associated with significant reductions in the duration of mechanical ventilation, ICU length of stay, and total hospital costs.

11. To Summarize

  • Impact on Current Practice: This trial was highly influential as it provided not only clinical but also strong economic evidence to support the use of sedation protocols and the goal of light sedation in the ICU.
  • Specific Recommendations:
    • Patient Selection: For the broad population of adult ICU patients requiring mechanical ventilation.
    • Actionable Intervention: Implement a nurse-driven, protocolized sedation strategy that utilizes a validated sedation scale (like RASS) to target light sedation.
    • Expected Benefit: This strategy can be expected to reduce the duration of ventilation, shorten ICU stay, and significantly decrease the costs of care.
  • What This Trial Does NOT Mean: This trial does NOT mean that all patients must be lightly sedated at all times. It supports a general strategy, but sedation should always be individualized.
  • Implementation Caveats: The success of this strategy is dependent on a multidisciplinary team approach and the empowerment of bedside nurses to manage sedation according to the protocol.

12. Context and Related Studies

  • Building on Previous Evidence: The Devlin et al. trial (2010) built upon the clinical findings of earlier landmark trials like Kress et al. (2000) and the ABC trial (2008) by adding a robust economic analysis.
  • Influence on Subsequent Research: The findings of this trial have been a key component in the evidence base supporting the “A” (Assess, prevent, and manage pain) and “B” (Both spontaneous awakening and breathing trials) components of the ABCDEF bundle for ICU care.

13. Unresolved Questions & Future Directions

  • Unresolved Questions: The optimal way to manage sedation in specific, challenging patient populations (e.g., severe ARDS, status asthmaticus) remains an area of investigation.
  • Future Directions: Subsequent research has focused on comparing different sedative agents (e.g., MENDS2 trial) and on the long-term cognitive and psychological outcomes associated with different sedation strategies.

14. External Links

15. Framework for Critical Appraisal

  • Clinical Question: The research question was highly relevant, addressing both the clinical and economic impact of a fundamental aspect of ICU care.
  • Methods: The randomized controlled trial design was appropriate. The main methodological weakness is the single-center, unblinded design, which limits generalizability and introduces a risk of performance bias.
  • Results: The study reported statistically significant and clinically important benefits for the intervention across multiple key outcomes, including duration of ventilation, length of stay, and cost.
  • Conclusions and Applicability: The authors’ conclusion is well-supported by the data. Despite being a single-center study, the pragmatic nature of the intervention and the consistency of its findings with other major trials in the field make its conclusions highly influential and applicable to most modern ICUs.

16. Disclaimer and Contact

  • This summary is provided by the Academic Committee of ESBICM (ACE) to facilitate the understanding of this study; readers are advised to refer to the original trial document for a deeper understanding. If you find any information incorrect, or missing, or it needs an update or have a request for a specific critical care trial summary, kindly write to us at academics[at]esbicm.org.
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