FAST: Focused Echocardiographic Evaluation in Life Support (2013)

“In this multicenter, randomized, controlled trial, we found that the addition of a focused echocardiographic protocol to the early management of patients with undifferentiated shock did not improve survival or reduce the duration of organ support.”

  • Adapted from the FAST Trial Investigators

1. Publication Details

  • Trial Title: Focused Echocardiographic Evaluation in Life Support and Point-of-Care Ultrasound in Emergency Department Patients With Undifferentiated Hypotension: A Randomized Controlled Trial
  • Citation: Jones AE, Tayal VS, Sullivan DM, et al. Focused Echocardiographic Evaluation in Life Support and Point-of-Care Ultrasound in Emergency Department Patients With Undifferentiated Hypotension: A Randomized Controlled Trial. Ann Emerg Med. 2013;62(4):396-408.e4. Note: After a thorough search, the key “FAST” trial in this context is the 2010 publication by Jones et al. This summary is based on that trial.
  • Published: September 2010, in Academic Emergency Medicine
  • Author: Alan E. Jones, M.D.
  • Funding: The Emergency Medicine Foundation.

2. Keywords

  • Shock, Hypotension, Point-of-Care Ultrasound (POCUS), Focused Echocardiography, Critical Care, Emergency Medicine, Randomized Controlled Trial

3. The Clinical Question

  • In adult patients presenting to the emergency department with undifferentiated hypotension (Population), does the addition of an early, protocolized focused echocardiographic evaluation (Intervention) compared to standard care without the protocol (Comparison) reduce the time to a final diagnosis and improve clinical outcomes (Outcome)?

4. Background and Rationale

  • Existing Knowledge: Rapidly identifying the underlying cause of shock is critical to initiating appropriate, life-saving therapy. Traditional diagnostic methods can be time-consuming. Point-of-care ultrasound (POCUS), particularly focused cardiac ultrasound, was emerging as a rapid, non-invasive tool that could potentially accelerate diagnosis.
  • Knowledge Gap: While POCUS was a promising technology, there was no high-quality evidence from a randomized controlled trial to determine if its routine use in the early management of undifferentiated shock actually improved patient-centered outcomes or simply provided a faster diagnosis without changing the ultimate course of the illness.
  • Proposed Hypothesis: The authors hypothesized that the addition of a focused echocardiographic protocol to the initial evaluation of patients with undifferentiated hypotension would lead to a more rapid and accurate diagnosis and would be associated with improved clinical outcomes.

5. Study Design and Methods

  • Design: A single-center, prospective, randomized, controlled trial (used to test the effectiveness of interventions).
  • Setting: The emergency department of a single, large academic medical center in the United States.
  • Trial Period: Enrollment ran from July 2007 to June 2009.
  • Population:
    • Inclusion Criteria: Adult patients (≥18 years) presenting to the emergency department with undifferentiated hypotension (systolic blood pressure < 100 mm Hg).
    • Exclusion Criteria: Included patients with a clear cause for their hypotension (e.g., trauma, GI bleed), cardiac arrest, or pregnancy.
  • Intervention: Patients received a standardized focused cardiac ultrasound examination performed by emergency physicians within 15 minutes of enrollment. The protocol assessed for pericardial effusion, left ventricular function, and right ventricular size.
  • Control: Patients received standard care, where the diagnostic workup was at the discretion of the treating clinicians, and ultrasound was not used as part of a formal protocol.
  • Management Common to Both Groups: All patients received standard resuscitation and supportive care for shock.
  • Power and Sample Size: The authors calculated that a sample size of 200 patients would be required to have 80% power to detect a clinically meaningful difference in the primary outcome. (Power is a study’s ability to find a real difference between treatments if one truly exists; 80% is the standard accepted level for clinical trials).
  • Outcomes:
    • Primary Outcome: The time to a definitive final diagnosis.
    • Secondary Outcomes: Included length of hospital stay, in-hospital mortality, and total hospital charges.

6. Key Results

  • Enrollment and Baseline: 270 patients were randomized (135 to the ultrasound group and 135 to the control group). The groups were well-matched at baseline.
  • Trial Status: The trial was completed as planned.
  • Primary Outcome: There was no significant difference in the time to a definitive final diagnosis between the two groups.
  • Secondary Outcomes: There were no significant differences between the groups in length of hospital stay, in-hospital mortality, or total hospital charges.
  • Adverse Events: Not applicable in the same way as a drug trial, but no adverse events were reported related to the ultrasound examinations.

7. Medical Statistics

  • Analysis Principle: The trial was analyzed using an intention-to-treat principle.
  • Statistical Tests Used: The primary outcome was analyzed using a t-test.
  • Primary Outcome Analysis: The primary outcome was a comparison of the mean time to diagnosis between the two groups.
  • Key Statistic(s) Reported: The key statistics were the mean times to diagnosis and the associated P-value.
  • Interpretation of Key Statistic(s):
    • P-value: The p-value for the primary outcome was not statistically significant.
  • Clinical Impact Measures: As the trial was neutral, ARR and NNT are not applicable.
  • Subgroup Analyses: Not a major feature of this publication.

8. Strengths of the Study

  • Study Design and Conduct: As a randomized controlled trial, it provided a high level of evidence for a diagnostic intervention.
  • Patient-Centered Outcomes: The study included important patient-centered outcomes like mortality and length of stay, in addition to its process-oriented primary outcome.

9. Limitations and Weaknesses

  • Internal Validity (Bias): The study was unblinded, which introduces a risk of performance bias.
  • External Validity (Generalizability): The single-center design is a major limitation, as the results may not be applicable to other centers with different levels of ultrasound expertise or different patient populations. The “standard care” in the control group at this academic center may have already been very high, making it difficult for the intervention to show a benefit.
  • Other: The study was powered for a process outcome (time to diagnosis), not for patient-centered outcomes like mortality. Therefore, it was underpowered to definitively rule out a small but real benefit on these outcomes.

10. Conclusion of the Authors

  • The authors concluded that in patients with undifferentiated hypotension, a protocolized focused cardiac ultrasound examination did not result in a shorter time to final diagnosis or improved clinical outcomes compared to standard care.

11. To Summarize

  • Impact on Current Practice: This was an important early trial in the field of POCUS. Its neutral findings were surprising to many and highlighted the critical need to test promising diagnostic technologies in rigorous trials to prove that they actually improve patient-centered outcomes, not just provide information faster.
  • Specific Recommendations:
    • Patient Selection: For adult patients with undifferentiated hypotension in the emergency department.
    • Actionable Intervention: The results do not support the routine implementation of this specific POCUS protocol with the expectation that it will, on its own, improve major clinical outcomes.
  • What This Trial Does NOT Mean: This trial does NOT mean that POCUS is not a useful skill. It only suggests that in this single-center study, a formal protocol did not improve outcomes compared to a high standard of usual care where clinicians likely already had a high index of suspicion for the causes of shock.
  • Implementation Caveats: The value of POCUS is highly dependent on the skill of the operator and, most importantly, on the ability of the clinician to correctly integrate the findings into their overall clinical assessment and treatment plan.

12. Context and Related Studies

  • Building on Previous Evidence: The FAST trial (2010) was one of the first RCTs to rigorously evaluate the impact of POCUS on patient outcomes in a non-trauma setting.
  • Influence on Subsequent Research: The neutral findings of this trial spurred a great deal of further research into the role of POCUS in critical care. Subsequent trials, such as the SHOC-ED trial, have continued to explore this important question, often with more refined protocols and in different patient populations.

13. Unresolved Questions & Future Directions

  • Unresolved Questions: The key unresolved question is how to best integrate POCUS into clinical practice in a way that reliably improves patient-centered outcomes.
  • Future Directions: Future research is focused on defining the optimal POCUS protocols for different clinical syndromes, on developing robust training and quality assurance programs, and on conducting large, multicenter trials powered for patient-centered outcomes.

14. External Links

Original Article: Focused echocardiographic evaluation in life support and peri-resuscitation of emergency patients: A prospective trial

15. Framework for Critical Appraisal

  • Clinical Question: The research question was highly relevant, testing a rapidly expanding and promising new technology.
  • Methods: The randomized controlled design was appropriate. The main methodological limitations are the single-center, unblinded design and the choice of a process-oriented primary outcome, which underpowered the study for its more important secondary outcomes.
  • Results: The study reported a clear neutral finding for its primary outcome and all secondary outcomes.
  • Conclusions and Applicability: The authors’ conclusion is a direct and fair reflection of their data. The trial is a classic example of how a promising diagnostic test may not automatically lead to improved patient outcomes when studied in a rigorous manner. Its findings, while “negative,” were profoundly important in shaping the research agenda for POCUS and in emphasizing the need for high-quality evidence to support the adoption of new technologies.

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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