Anesthesia-handover Checklist and Perioperative Outcomes in Elderly

Sponsor

Peking University First Hospital (Other)

Overall Status

Recruiting

CT.gov ID

NCT04377633

Collaborator

(none)

1,440

Enrollment

Location

Arms

35.5

Anticipated Duration (Months)

40.6

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Elderly Patients Major Surgery Anesthesia; Adverse Effect Prevention Postoperative Complications	Procedure: Oral handover Procedure: Checklist handover	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

1440 participants

Allocation:

Non-Randomized

Intervention Model:

Sequential Assignment

Masking:

None (Open Label)

Primary Purpose:

Prevention

Official Title:

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

Actual Study Start Date :

Jul 16, 2020

Anticipated Primary Completion Date :

Jun 1, 2022

Anticipated Study Completion Date :

Jul 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Sham Comparator: Pre-intervention 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 as usual, i.e., oral exchange of pertinent clinical information.
Experimental: Post-intervention Anesthesia handover during surgery will be performed according to a structured checklist.	Procedure: Checklist handover Anesthesia handover during surgery will be performed according to a structured handover checklist.

Arm

Intervention/Treatment

Sham Comparator: Pre-intervention

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 as usual, i.e., oral exchange of pertinent clinical information.

Experimental: Post-intervention

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

Procedure: Checklist handover

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

Outcome Measures

Primary Outcome Measures

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

Intensive care unit admission after surgery. [Up to 30 days after surgery.]
Intensive care unit admission after surgery.
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 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.
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.
Length of hospital stay after surgery. [Up to 30 days after surgery.]
Length of hospital stay after surgery.
All-cause mortality within 30 days after surgery. [Up to 30 days after surgery.]
All-cause mortality within 30 days after surgery.

Other Outcome Measures

Pain intensity within 3 days after surgery. [Up to 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.
Subjective sleep quality within 3 days after surgery. [Up to 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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

65 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

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).

Exclusion Criteria:

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.