Original ArticleThe 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
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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Cited by (0)
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).