Anesthesia-handover Checklist and Perioperative Outcomes in Elderly

Postoperative Complications Clinical Trial

Official title:

Impact of an Anesthesia-handover Checklist on Perioperative Outcomes of Elderly Patients Undergoing Major Noncardiac Surgery: A Prospective Before-and-after Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04377633
• Other study ID #: 2020-042
• Status: Recruiting
• Phase: N/A
• Start date: July 16, 2020
• Est. completion date: July 2023

Study information

• Verified date: September 2021
• Source: Peking University First Hospital
• Contact: Dong-Xin Wang, MD, PhD
• Phone: 86(10) 83572784
• Email: wangdongxin[@]hotmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1440
• Est. completion date: July 2023
• Est. primary completion date: June 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years and older

Eligibility

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.

Related Conditions & MeSH terms

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

Intervention

Procedure:
• Oral handover
Anesthesia handover during surgery will be performed as usual, i.e., oral exchange of pertinent clinical information.
• Checklist handover
Anesthesia handover during surgery will be performed according to a structured handover checklist.

Locations

Country	Name	City	State
China	Peking University First Hospital	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Peking University First Hospital

Country where clinical trial is conducted

China, 

References & Publications (27)

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* Note: There are 27 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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.	Up to 3 days after surgery.
Other	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.	Up to 3 days after surgery.
Primary	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	Intensive care unit admission after surgery.	Intensive care unit admission after surgery.	Up to 30 days after surgery.
Secondary	Length of stay in the intensive care unit after surgery.	Length of stay in the intensive care unit after surgery.	Up to 30 days after surgery.
Secondary	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.	Up to 3 days after surgery.
Secondary	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.	Up to 30 days after surgery.
Secondary	Length of hospital stay after surgery.	Length of hospital stay after surgery.	Up to 30 days after surgery.
Secondary	All-cause mortality within 30 days after surgery.	All-cause mortality within 30 days after surgery.	Up to 30 days after surgery.