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Anesthesia-handover Checklist and Perioperative Outcomes in Elderly

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ClinicalTrials.gov Identifier: NCT04377633
Recruitment Status : Recruiting
First Posted : May 6, 2020
Last Update Posted : September 16, 2021
Sponsor:
Information provided by (Responsible Party):
Dong-Xin Wang, 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.

Condition or disease Intervention/treatment Phase
Elderly Patients Major Surgery Anesthesia; Adverse Effect Prevention Postoperative Complications Procedure: Oral handover Procedure: Checklist handover Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated 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 : July 16, 2020
Estimated Primary Completion Date : June 2022
Estimated Study Completion Date : July 2023

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.




Primary Outcome Measures :
  1. A composite incidence of all complications within 30 days after surgery. [ Time Frame: 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 :
  1. Intensive care unit admission after surgery. [ Time Frame: Up to 30 days after surgery. ]
    Intensive care unit admission after surgery.

  2. Length of stay in the intensive care unit after surgery. [ Time Frame: Up to 30 days after surgery. ]
    Length of stay in the intensive care unit after surgery.

  3. Incidence of organ injury (delirium, acute kidney injury, and acute myocardial injury) within 3 days after surgery. [ Time Frame: 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.

  4. Incidence of major complications within 30 days after surgery. [ Time Frame: 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.

  5. Length of hospital stay after surgery. [ Time Frame: Up to 30 days after surgery. ]
    Length of hospital stay after surgery.

  6. All-cause mortality within 30 days after surgery. [ Time Frame: Up to 30 days after surgery. ]
    All-cause mortality within 30 days after surgery.


Other Outcome Measures:
  1. Pain intensity within 3 days after surgery. [ Time Frame: 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.

  2. Subjective sleep quality within 3 days after surgery. [ Time Frame: 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.



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Ages Eligible for Study:   65 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04377633


Contacts
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Contact: Dong-Xin Wang, MD, PhD 86(10) 83572784 wangdongxin@hotmail.com
Contact: Xiao-Ling Zhang, MD 86(10) 83575138 lani-zxl@163.com

Locations
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China, Beijing
Peking University First Hospital Recruiting
Beijing, Beijing, China, 100034
Contact: Dong-Xin Wang, MD, PhD    86(10) 83572784    wangdongxin@hotmail.com   
Contact: Xiao-Ling Zhang, MD    86(10) 83575138    lani-zxl@163.com   
Sponsors and Collaborators
Peking University First Hospital
Investigators
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Principal Investigator: Dong-Xin Wang, MD, PhD Peking University First Hospital
Publications:

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Responsible Party: Dong-Xin Wang, Professor, Department of Anaesthesiology and Critical Care Medicine, Peking University First Hospital
ClinicalTrials.gov Identifier: NCT04377633    
Other Study ID Numbers: 2020-042
First Posted: May 6, 2020    Key Record Dates
Last Update Posted: September 16, 2021
Last Verified: September 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Dong-Xin Wang, Peking University First Hospital:
Elderly patients
Major surgery
Anesthesia handover
Handover checklist
Postoperative complications
Additional relevant MeSH terms:
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Postoperative Complications
Pathologic Processes