DEVICE: Video vs. Direct Laryngoscopy in Critical Illness (2023)

“Among critically ill adults undergoing tracheal intubation in an intensive care unit, the use of a video laryngoscope resulted in a significantly higher incidence of successful intubation on the first attempt than the use of a direct laryngoscope.”

  • The DEVICE Trial Investigators

1. Publication Details

  • Trial Title: Video versus Direct Laryngoscopy for Tracheal Intubation of Critically Ill Adults
  • Citation: Prekker ME, Driver BE, Trent SA, et al. Video versus Direct Laryngoscopy for Tracheal Intubation of Critically Ill Adults. N Engl J Med. 2023;389(5):418-429. DOI: 10.1056/NEJMoa2301601
  • Published: August 3, 2023, in The New England Journal of Medicine
  • Author: Matthew E. Prekker, M.D., M.P.H.
  • Funding: United States National Heart, Lung, and Blood Institute (NHLBI).

2. Keywords

  • Tracheal Intubation, Airway Management, Video Laryngoscopy, Direct Laryngoscopy, Critical Care, Randomized Controlled Trial

3. The Clinical Question

  • In critically ill adults undergoing tracheal intubation in the ICU (Population), does the use of a video laryngoscope (Intervention) compared to a direct laryngoscope (Comparison) increase the rate of successful intubation on the first attempt (Outcome)?

4. Background and Rationale

  • Existing Knowledge: Successful intubation on the first attempt is critical to prevent life-threatening complications in critically ill patients. Video laryngoscopy provides a better view of the glottis than direct laryngoscopy, but it was unclear if this improved view translated into higher first-pass success rates in the challenging ICU environment.
  • Knowledge Gap: Previous trials comparing video and direct laryngoscopy had produced conflicting results, were often limited to the operating room or emergency department, and had not definitively established the superiority of one device over the other for ICU intubations.
  • Proposed Hypothesis: The authors hypothesized that the use of a video laryngoscope would be superior to the use of a direct laryngoscope in achieving successful intubation on the first attempt among critically ill adults.

5. Study Design and Methods

  • Design: A multicenter, pragmatic, randomized, controlled trial (used to test the effectiveness of interventions).
  • Setting: 17 emergency departments and intensive care units (ICUs) in the United States.
  • Trial Period: Enrollment ran from September 2019 to June 2022.
  • Population:
    • Inclusion Criteria: Adult patients (≥18 years) undergoing tracheal intubation in the emergency department or ICU.
    • Exclusion Criteria: Included prisoners, pregnant patients, and patients with an immediate need for a surgical airway.
  • Intervention: Patients were intubated using a video laryngoscope as the primary device.
  • Control: Patients were intubated using a direct laryngoscope as the primary device.
  • Management Common to Both Groups: The choice of blade type (e.g., Macintosh, Miller), use of a bougie or stylet, and all other aspects of the intubation procedure were at the discretion of the treating clinician.
  • Power and Sample Size: The authors calculated that a sample size of 1400 patients would provide 90% power to detect an 8% absolute difference in first-attempt intubation success. (Power is a study’s ability to find a real difference between treatments if one truly exists; 90% power means the study had a 90% chance of detecting the specified effect, which is considered very high).
  • Outcomes:
    • Primary Outcome: Successful intubation on the first attempt.
    • Secondary Outcomes: Included the incidence of severe hypoxemia (SpO2 < 80%), esophageal intubation, and major cardiovascular collapse.

6. Key Results

  • Enrollment and Baseline: 1417 patients were randomized (705 to video laryngoscopy and 712 to direct laryngoscopy). The groups were well-matched at baseline. The majority of operators were resident physicians or fellows.
  • Trial Status: The trial was completed as planned.
  • Primary Outcome: Successful intubation on the first attempt was significantly higher in the video laryngoscopy group: 600 of 705 patients (85.1%) in the video group were successfully intubated on the first try, compared with 504 of 712 patients (70.8%) in the direct laryngoscopy group (p<0.001).
  • Secondary Outcomes: There was no significant difference between the groups in the incidence of severe hypoxemia. However, esophageal intubation was less common in the video laryngoscopy group.
  • Adverse Events: The incidence of severe cardiovascular collapse was similar in both groups.

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 chi-square test.
  • Primary Outcome Analysis: The primary outcome was a comparison of the proportions of successful first-attempt intubations between the two groups.
  • Key Statistic(s) Reported: The key statistics were the absolute success rates and the associated P-value.
  • Interpretation of Key Statistic(s):
    • P-value: The p-value of <0.001 is extremely low, indicating that the observed difference in first-pass success is highly statistically significant and very unlikely to be due to chance (a result is conventionally considered statistically significant if the p-value is less than 0.05).
  • Clinical Impact Measures:
    • Absolute Risk Reduction (ARR) (for the adverse outcome of first-attempt failure):
      • Formula: ARR = (Risk in Control Group) – (Risk in Intervention Group)
      • Calculation: ARR = (100% – 70.8%) – (100% – 85.1%) = 29.2% – 14.9% = 14.3%.
      • Clinical Meaning: For every 100 patients intubated with a video laryngoscope instead of a direct laryngoscope, about 14 first-attempt failures were prevented.
    • Number Needed to Treat (NNT):
      • Formula: NNT = 1 / ARR
      • Calculation: NNT = 1 / 0.143 = 6.99, which is rounded up to 7.
      • Clinical Meaning: You would need to use a video laryngoscope in 7 patients to achieve one additional successful intubation on the first attempt.
  • Subgroup Analyses: The benefit of video laryngoscopy was consistent across all pre-specified subgroups, including operator experience level.

8. Strengths of the Study

  • Study Design and Conduct: The large, multicenter, pragmatic, randomized design provided high-quality evidence on a critical procedural question.
  • Generalizability: The inclusion of both emergency department and ICU patients from 17 diverse sites, with operators of varying experience levels, makes the findings highly generalizable to real-world academic practice.
  • Statistical Power: The study was large and adequately powered for its primary outcome.
  • Patient-Centered Outcomes: The primary outcome of first-attempt success is a critical, patient-centered procedural outcome directly linked to patient safety.

9. Limitations and Weaknesses

  • Internal Validity (Bias): The study was unblinded, which is an unavoidable limitation in a procedural trial and introduces a risk of performance bias.
  • External Validity (Generalizability): The study was conducted in academic centers where trainees perform most intubations. The benefit of video laryngoscopy might be different for highly experienced attending physicians.
  • Other: The trial did not mandate the use of a bougie or stylet, and the high rate of stylet use in the video laryngoscopy arm may have contributed to its success.

10. Conclusion of the Authors

  • Among critically ill adults undergoing tracheal intubation, the use of a video laryngoscope resulted in a significantly higher incidence of successful intubation on the first attempt than the use of a direct laryngoscope.

11. To Summarize

  • Impact on Current Practice: This was a landmark, practice-changing trial that provided definitive evidence supporting the routine use of video laryngoscopy as the primary device for intubating critically ill patients.
  • Specific Recommendations:
    • Patient Selection: For the broad population of adult ICU and emergency department patients requiring tracheal intubation.
    • Actionable Intervention: Video laryngoscopy should be the default initial device for tracheal intubation in critically ill adults.
    • Expected Benefit: This strategy can be expected to prevent one first-attempt failure for every 7 patients intubated.
  • What This Trial Does NOT Mean: This trial does NOT mean that direct laryngoscopy is obsolete. It remains a critical core skill, especially for situations where a video laryngoscope may fail or be unavailable.
  • Implementation Caveats: The success of video laryngoscopy is dependent on proper training and familiarity with the device.

12. Context and Related Studies

  • Building on Previous Evidence: The DEVICE trial (2023) was designed to provide a more definitive answer to the “video vs. direct” debate than previous, smaller, and often conflicting trials.
  • Influence on Subsequent Research: The definitive positive result of this large trial will be highly influential in shaping airway management guidelines and is likely to accelerate the adoption of video laryngoscopy as the standard of care in critical care settings.

13. Unresolved Questions & Future Directions

  • Unresolved Questions: The optimal type of video laryngoscope blade (e.g., standard vs. hyperangulated) and the role of a bougie versus a stylet during video laryngoscopy remain areas of investigation.
  • Future Directions: Future research may focus on optimizing the technique of video laryngoscopy and on training methods to ensure proficiency for all operators.

14. External Links

15. Framework for Critical Appraisal

  • Clinical Question: The research question was highly relevant, addressing a very common and high-stakes procedure in critical care.
  • Methods: The large, multicenter, pragmatic RCT design was appropriate and robust. The main methodological weakness is the lack of blinding, which is unavoidable. The inclusion of operators with varying experience levels is a strength that enhances generalizability.
  • Results: The study reported a large, statistically significant, and clinically important benefit for its primary outcome (NNT of 7). The findings were consistent across all major subgroups.
  • Conclusions and Applicability: The authors’ conclusion is a direct and fair reflection of the data. The high external validity of this pragmatic trial means its findings are broadly applicable to most academic emergency departments and ICUs and provide a strong rationale for adopting video laryngoscopy as the primary intubating device.

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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