An interventional study of Oral handover and Checklist handover in Elderly Patients, Major Surgery and Anesthesia; Adverse Effect, sponsored by Peking University First Hospital. Completed at 1 site in China. Open to participants aged 65 Years and older. Per ClinicalTrials.gov, last updated 2024-12-02.
Sponsored by Peking University First Hospital · Not applicable, Interventional, and Prevention
With the increasing number of surgical cases, intraoperative handover of anesthesia care is common and inevitable. Verbal handover from one anesthesiologist to another during surgery are being used in many hospitals. However, verbal handover is often an informal, unstructured process during which omissions and errors can occur. It is possible that an improved anesthesia handover may reduce the related adverse events. This study aims to test the hypothesis that use of a well-designed, structured handover-checklist to improve handover quality may decrease the occurrence of postoperative complications in elderly patients undergoing major noncardiac surgery.
It was estimated that more than 9 million patients undergo surgery with a complete anesthesia handover each year worldwide. Verbal handover from one anesthesiologist to another during surgery are being used in many hospitals; and there is no unified patient handover guideline at present.
It is well recognized that the transfer-of-care is a point of vulnerability where valuable patient information can be distorted and omitted. A previous study of the investigators showed that handover of anesthesia care was associated with a higher risk of delirium in elderly patients after major noncardiac surgery. The World Health Organization has included communication during patient care handovers among its top 5 patient safety initiatives.
It is possible that an improved anesthesia-handover protocol may reduce the related adverse events. Many efforts have performed to optimize handover processes. However, handover quality between anesthesiologists has rarely been investigated. The investigators hypothesize that a well-designed, structured handover-checklist will improve handover quality and reduce the occurrence of postoperative complications.
1,233 studies on the registry are indexed under Postoperative Complications; 292 are open to participants now.
This study's enrollment of 1,421 is above the median of 119 across 689 interventional studies indexed under Postoperative Complications.
Browse Postoperative Complications studies →Peking University First Hospital is the lead sponsor of 378 studies on the registry; 178 are open to participants now.
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Exclusion Criteria:
Anesthesia handover during surgery will be performed as usual, i.e., a verbal exchange of pertinent clinical information.
Procedure: Oral handover
Anesthesia handover during surgery will be performed according to a structured checklist.
Procedure: Checklist handover
Anesthesia handover during surgery will be performed as usual, i.e., oral exchange of pertinent clinical information.
Anesthesia handover during surgery will be performed according to a structured handover checklist.
A composite incidence of all complications within 30 days after surgery.
Include organ injury (delirium, acute kidney injury, and myocardial injury) within 3 days and other major complications (class II or higher on Clavien-Dindo classification) within 30 days after surgery.
Time frame: Up to 30 days after surgery.
Intensive care unit admission after surgery.
Intensive care unit admission after surgery.
Time frame: Up to 30 days after surgery.
Length of stay in the intensive care unit after surgery.
Length of stay in the intensive care unit after surgery.
Time frame: Up to 30 days after surgery.
Incidence of organ injury (delirium, acute kidney injury, and acute myocardial injury) within 3 days after surgery.
Delirium is diagnosed with the Confusion Assessment Method. Acute kidney injury is diagnosed according to the KDIGO (Kidney Disease: Improving Global Outcomes) Criteria. Acute myocardial injury is diagnosed according to the serum cardiac tropinin I level.
Time frame: Up to 3 days after surgery.
Incidence of major complications within 30 days after surgery.
Major complications are defined as newly occurred conditions that are harmful to patients' recovery and required medical therapy, i.e., class II or higher on the Clavien-Dindo classification.
Time frame: Up to 30 days after surgery.
Length of hospital stay after surgery.
Length of hospital stay after surgery.
Time frame: Up to 30 days after surgery.
All-cause mortality within 30 days after surgery.
All-cause mortality within 30 days after surgery.
Time frame: Up to 30 days after surgery.
Pain intensity within 3 days after surgery.
Pain intensity is assessed with the Numeric Rating Scale, an 11-point scale where 0=no pain and 10=the worst pain.
Time frame: Up to 3 days after surgery.
Subjective sleep quality within 3 days after surgery.
Subjective sleep quality is assessed with the Numeric Rating Scale, an 11-point scale where 0=the best sleep and 10=the worst sleep.
Time frame: Up to 3 days after surgery.
Plan to share: No
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Peking University First Hospital