Anesthesia-handover Checklist and Perioperative Outcomes in Elderly

Not Applicable

Completed

• Conditions: Postoperative Complications; Major Surgery; Anesthesia; Adverse Effect; Elderly Patients; Prevention
• Interventions: Procedure: Oral handover; Procedure: Checklist handover

• Registration Number: NCT04377633
• Lead Sponsor: Peking University First Hospital

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Study First Submitted: 2020-05-04
• Study First Submitted QC: 2020-05-04
• Study First Posted: 2020-05-06
• Study Start: 2020-07-16
• Primary Completion: 2023-11-23
• Study Completion: 2023-12-23
• Status Verified: 2024-11
• Last Update Submitted: 2024-11-27
• Last Update Posted: 2024-12-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1421

Inclusion Criteria

1. Elderly patients (aged 65 years and over);
2. Scheduled to undergo major non-cardiac surgery with an expected duration of at least 2 hours;
3. Requirement of complete handover between anesthesiologists during surgery (initial anesthesiologist no longer returns).

Exclusion Criteria

1. Preoperative history of schizophrenia, epilepsy, Parkinsonism or myasthenia gravis;
2. Inability to communicate before surgery (coma, profound dementia or language barrier);
3. Craniocerebral injury or neurosurgery;
4. Severe liver dysfunction (Child-Pugh grade C), severe renal dysfunction (requiring dialysis), or expected survival of <24 hours.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
Pre-intervention	Oral handover	Anesthesia handover during surgery will be performed as usual, i.e., a verbal exchange of pertinent clinical information.
Post-intervention	Checklist handover	Anesthesia handover during surgery will be performed according to a structured checklist.

Primary Outcome Measures

Name	Time	Method
A composite incidence of all complications within 30 days after surgery.	Up to 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.

Secondary Outcome Measures

Name	Time	Method
Length of stay in the intensive care unit after surgery.	Up to 30 days after surgery.	Length of stay in the intensive care unit after surgery.
Incidence of major complications within 30 days after surgery.	Up to 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.
All-cause mortality within 30 days after surgery.	Up to 30 days after surgery.	All-cause mortality within 30 days after surgery.
Intensive care unit admission after surgery.	Up to 30 days after surgery.	Intensive care unit admission after surgery.
Length of hospital stay after surgery.	Up to 30 days after surgery.	Length of hospital stay after surgery.
Incidence of organ injury (delirium, acute kidney injury, and acute myocardial injury) within 3 days after surgery.	Up to 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.

Trial Locations

Locations (1)

Peking University First Hospital; 🇨🇳 Beijing, Beijing, China