Original Article
The Impact on 30-Day Mortality From a Brief Focused Ultrasound-Guided Management Protocol Immediately Before Emergency Noncardiac Surgery in Critically Ill Patients: A Multicenter Randomized Controlled Trial

https://doi.org/10.1053/j.jvca.2021.05.023Get rights and content

Objective

To determine whether brief ultrasound-guided treatment of hemodynamic shock and respiratory failure immediately before emergency noncardiac surgery reduced 30-day mortality.

Design

Parallel, nonblinded, randomized trial with 1:1 allocation to control and intervention groups.

Setting

Twenty-eight major hospitals within China.

Participants

Six-hundred sixty patients ≥14 years of age, scheduled for emergency noncardiac surgery with evidence of shock (heart rate >120 beat/min, systolic blood pressure< 90 mmHg or requiring inotrope infusion), or respiratory failure (Pulse Oxygen Saturation <92%, respiratory rate >20 beat/min, or requiring mechanical ventilation).

Interventions

A brief (<15 minutes) focused ultrasound of ventricular filling and function, lung, and peritoneal spaces, with predefined treatment recommendation based on the ultrasound was performed before surgery or standard care.

Measurements and Main Results

The primary outcome was 30-day mortality. Secondary outcomes included changes in medical or surgical diagnosis and management due to ultrasound, intensive care unit, and hospital stay and cost, and Short Form-8 quality-of-life scores. Although there were frequent changes in diagnosis (82%) and management (49%) after the ultrasound, mortality at 30 days was not different between groups (50 [15.7%] v 53 [16.3%]; odds ratio 1.05, 0.69-1.6, p = 0.826). There were no differences in the secondary outcomes of the days spent in the hospital (mean 13.8 days, 95% confidence interval [CI] 12.1-15.6 v 14.4 d, 11.8-17.1, p = 0.718) or intensive care unit (mean 9.3 days, 95% CI 7.7-11.0 v 8.7 d, 7.2-10.2, p = 0.562), hospital cost (USD$14.5K, 12.2-16.7 v 13.7, 11.5-15.9, p = 0.611) or Short Form-8 scores at one year (mean 80.9, 95% CI 78.4-83.3 v 79.7, 76.9-82.5, p = 0.54) between participants allocated to the ultrasound and control groups.

Conclusions

In critically ill patients with hemodynamic shock or respiratory failure, a focused ultrasound-guided management did not reduce 30-day mortality but led to frequent changes in diagnosis and patient management.

Section snippets

Trial Design

This parallel group, randomized, controlled, multicenter trial was approved by the Ethics Committee of West China Hospital (institutional review board #4306) and all 28 participating hospitals. Participants were randomized to either ultrasound or control groups in a 1:1 ratio at all centers. This study has been carried out in accordance with the Declaration of Helsinki code of ethics. Written informed consent was obtained from all participants (or power of attorney) before enrollment in the

Results

Of the 33 centers that volunteered to participate in the trial, all participants achieved a pass mark of >60% in the MCQ test, but 5 centers were not allowed to participate owing to failure to provide ultrasound images acquired during the pathology practice phase of the training, leaving 28 centers for inclusion in the trial. Thirty-three anesthesiologist sonographers were involved in the study. An interim analysis was performed after 660 patients were randomized to identify the size of the

Discussion

In this randomized controlled trial, the authors used a specific, focused ultrasound protocol (left ventricular systolic function and volume), the BLUE lung ultrasound,14 and FAST abdominal ultrasound21 to guide perioperative management of critically ill patients undergoing emergency noncardiac surgery. The trial was terminated early owing to futility, with no meaningful differences found for 30-day mortality. This trial also showed no important differences in length of ICU or hospital stay,

Conclusions

No significant change was found on postoperative 30-day mortality after an intervention of focused ultrasound assessment. There were also no further significant changes on length of stay in hospital or ICU, and hospital costs or patient reported quality of life in patients undergoing emergency noncardiac surgery who were in hemodynamic shock or respiratory failure. Performing a full FoCUS examination may have differing outcomes than a brief examination.

Acknowledgments

We thank Juan Liu (Department of Anesthesia, West China Hospital) who contributed to the trial design and data collection and produced the electronic case report for this study.

Conflict of Interest

There were no conflicts of interest.

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    This trial was supported by the National Key R&D Program of China (2018YFC2001800) and Research Grant from the 1.3.5. project for disciplines of excellence. West China Hospital, Sichuan University (Zy2016101).

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