Clinical trial NCT04377633: Anesthesia-handover Checklist and Perioperative Outcomes in Elderly
Official title: Impact of an Anesthesia-handover Checklist on Perioperative Outcomes of Elderly Patients Undergoing Major Noncardiac Surgery: A Prospective Before-and-after Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Elderly Patients
Major Surgery
Anesthesia; Adverse Effect
Prevention
Postoperative Complications
Keywords: Elderly patients
Major surgery
Anesthesia handover
Handover checklist
Postoperative complications
Lead sponsor: Peking University First Hospital
Sponsor class: OTHER
First posted: 2020-05-06
Enrollment: 1421
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: PREVENTION

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.

Eligibility criteria: 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.

Primary outcomes:
measure: A composite incidence of all complications within 30 days after surgery.
timeFrame: Up to 30 days after surgery.
Secondary outcomes:
measure: Intensive care unit admission after surgery.
timeFrame: Up to 30 days after surgery.
measure: Length of stay in the intensive care unit after surgery.
timeFrame: Up to 30 days after surgery.
measure: Incidence of organ injury (delirium, acute kidney injury, and acute myocardial injury) within 3 days after surgery.
timeFrame: Up to 3 days after surgery.
measure: Incidence of major complications within 30 days after surgery.
timeFrame: Up to 30 days after surgery.
measure: Length of hospital stay after surgery.
timeFrame: Up to 30 days after surgery.
measure: All-cause mortality within 30 days after surgery.
timeFrame: Up to 30 days after surgery.
Other outcomes:
measure: Pain intensity within 3 days after surgery.
timeFrame: Up to 3 days after surgery.
measure: Subjective sleep quality within 3 days after surgery.
timeFrame: Up to 3 days after surgery.
Locations:
city: Beijing
country: China
facility: Peking University First Hospital
state: Beijing
Study officials:
affiliation: Peking University First Hospital
name: Dong-Xin Wang, MD, PhD
role: PRINCIPAL_INVESTIGATOR
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