Anesthesia-handover Checklist and Perioperative Outcomes in Elderly

NCT04377633 | Completed

• 1 other identifier: 2020-042
• Study Type: interventional
• Target: 1,421
• Locations: 1 country
• Sites: 1

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.

Conditions

Elderly Patients; Major Surgery; Anesthesia; Adverse Effect; Prevention; Postoperative Complications

Keywords

Elderly patients; Major surgery; Anesthesia handover; Handover checklist; Postoperative complications

Outcome Measures

Primary Outcomes (1)

• 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.

  Up to 30 days after surgery.

Secondary Outcomes (6)

• Intensive care unit admission after surgery.

  Up to 30 days after surgery.

• Length of stay in the intensive care unit after surgery.

  Up to 30 days 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.

• Incidence of major complications within 30 days after surgery.

  Up to 30 days after surgery.

• Length of hospital stay after surgery.

  Up to 30 days after surgery.

Other Outcomes (2)

• Pain intensity within 3 days after surgery.

  Up to 3 days after surgery.

• Subjective sleep quality within 3 days after surgery.

  Up to 3 days after surgery.

Study Arms (2)

Pre-intervention

SHAM COMPARATOR

Anesthesia handover during surgery will be performed as usual, i.e., a verbal exchange of pertinent clinical information.

Procedure: Oral handover

Post-intervention

EXPERIMENTAL

Anesthesia handover during surgery will be performed according to a structured checklist.

Procedure: Checklist handover

Interventions

Oral handover PROCEDURE

Anesthesia handover during surgery will be performed as usual, i.e., oral exchange of pertinent clinical information.

Pre-intervention

Checklist handover PROCEDURE

Anesthesia handover during surgery will be performed according to a structured handover checklist.

Post-intervention

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Peking University First Hospital: lead

Study Sites (1)

Peking University First Hospital

Beijing, Beijing Municipality, 100034, China

Location

Related Publications (27)

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MeSH Terms

Conditions

Postoperative Complications

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Dong-Xin Wang, MD, PhD

  Peking University First Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, Department of Anaesthesiology and Critical Care Medicine

Study Record Dates

• First Submitted: May 4, 2020
• First Posted: May 6, 2020
• Study Start: July 16, 2020
• Primary Completion: November 23, 2023
• Study Completion: December 23, 2023
• Last Updated: December 2, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)