search
Back to results

Anesthesia-handover Checklist and Perioperative Outcomes in Elderly

Primary Purpose

Elderly Patients, Major Surgery, Anesthesia; Adverse Effect

Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Oral handover
Checklist handover
Sponsored by
Peking University First Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Elderly Patients focused on measuring Elderly patients, Major surgery, Anesthesia handover, Handover checklist, Postoperative complications

Eligibility Criteria

65 Years - undefined (Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Peking University First HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Sham Comparator

Experimental

Arm Label

Pre-intervention

Post-intervention

Arm Description

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

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Intensive care unit admission after surgery.
Intensive care unit admission after surgery.
Length of stay in the intensive care unit 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.
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.
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.
Length of hospital stay after surgery.
All-cause mortality within 30 days after surgery.
All-cause mortality within 30 days after surgery.

Full Information

First Posted
May 4, 2020
Last Updated
September 14, 2021
Sponsor
Peking University First Hospital
search

1. Study Identification

Unique Protocol Identification Number
NCT04377633
Brief Title
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

2. Study Status

Record Verification Date
September 2021
Overall Recruitment Status
Unknown status
Study Start Date
July 16, 2020 (Actual)
Primary Completion Date
June 2022 (Anticipated)
Study Completion Date
July 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Peking University First Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Elderly Patients, Major Surgery, Anesthesia; Adverse Effect, Prevention, Postoperative Complications
Keywords
Elderly patients, Major surgery, Anesthesia handover, Handover checklist, Postoperative complications

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Sequential Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
1440 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Pre-intervention
Arm Type
Sham Comparator
Arm Description
Anesthesia handover during surgery will be performed as usual, i.e., a verbal exchange of pertinent clinical information.
Arm Title
Post-intervention
Arm Type
Experimental
Arm Description
Anesthesia handover during surgery will be performed according to a structured checklist.
Intervention Type
Procedure
Intervention Name(s)
Oral handover
Intervention Description
Anesthesia handover during surgery will be performed as usual, i.e., oral exchange of pertinent clinical information.
Intervention Type
Procedure
Intervention Name(s)
Checklist handover
Intervention Description
Anesthesia handover during surgery will be performed according to a structured handover checklist.
Primary Outcome Measure Information:
Title
A composite incidence of all complications within 30 days after surgery.
Description
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.
Time Frame
Up to 30 days after surgery.
Secondary Outcome Measure Information:
Title
Intensive care unit admission after surgery.
Description
Intensive care unit admission after surgery.
Time Frame
Up to 30 days after surgery.
Title
Length of stay in the intensive care unit after surgery.
Description
Length of stay in the intensive care unit after surgery.
Time Frame
Up to 30 days after surgery.
Title
Incidence of organ injury (delirium, acute kidney injury, and acute myocardial injury) within 3 days after surgery.
Description
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.
Time Frame
Up to 3 days after surgery.
Title
Incidence of major complications within 30 days after surgery.
Description
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.
Time Frame
Up to 30 days after surgery.
Title
Length of hospital stay after surgery.
Description
Length of hospital stay after surgery.
Time Frame
Up to 30 days after surgery.
Title
All-cause mortality within 30 days after surgery.
Description
All-cause mortality within 30 days after surgery.
Time Frame
Up to 30 days after surgery.
Other Pre-specified Outcome Measures:
Title
Pain intensity within 3 days after surgery.
Description
Pain intensity is assessed with the Numeric Rating Scale, an 11-point scale where 0=no pain and 10=the worst pain.
Time Frame
Up to 3 days after surgery.
Title
Subjective sleep quality within 3 days after surgery.
Description
Subjective sleep quality is assessed with the Numeric Rating Scale, an 11-point scale where 0=the best sleep and 10=the worst sleep.
Time Frame
Up to 3 days after surgery.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Dong-Xin Wang, MD, PhD
Phone
86(10) 83572784
Email
wangdongxin@hotmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Xiao-Ling Zhang, MD
Phone
86(10) 83575138
Email
lani-zxl@163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dong-Xin Wang, MD, PhD
Organizational Affiliation
Peking University First Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Peking University First Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100034
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dong-Xin Wang, MD, PhD
Phone
86(10) 83572784
Email
wangdongxin@hotmail.com
First Name & Middle Initial & Last Name & Degree
Xiao-Ling Zhang, MD
Phone
86(10) 83575138
Email
lani-zxl@163.com

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
25332710
Citation
Choromanski D, Frederick J, McKelvey GM, Wang H. Intraoperative patient information handover between anesthesia providers. J Biomed Res. 2014 Sep;28(5):383-7. doi: 10.7555/JBR.28.20140001. Epub 2014 Jun 10.
Results Reference
background
PubMed Identifier
22569028
Citation
Siddiqui N, Arzola C, Iqbal M, Sritharan K, Guerina L, Chung F, Friedman Z. Deficits in information transfer between anaesthesiologist and postanaesthesia care unit staff: an analysis of patient handover. Eur J Anaesthesiol. 2012 Sep;29(9):438-45. doi: 10.1097/EJA.0b013e3283543e43.
Results Reference
background
PubMed Identifier
17954795
Citation
Singh H, Thomas EJ, Petersen LA, Studdert DM. Medical errors involving trainees: a study of closed malpractice claims from 5 insurers. Arch Intern Med. 2007 Oct 22;167(19):2030-6. doi: 10.1001/archinte.167.19.2030.
Results Reference
background
PubMed Identifier
16326783
Citation
Arora V, Johnson J, Lovinger D, Humphrey HJ, Meltzer DO. Communication failures in patient sign-out and suggestions for improvement: a critical incident analysis. Qual Saf Health Care. 2005 Dec;14(6):401-7. doi: 10.1136/qshc.2005.015107.
Results Reference
background
PubMed Identifier
18779462
Citation
Horwitz LI, Moin T, Krumholz HM, Wang L, Bradley EH. Consequences of inadequate sign-out for patient care. Arch Intern Med. 2008 Sep 8;168(16):1755-60. doi: 10.1001/archinte.168.16.1755.
Results Reference
background
PubMed Identifier
25440620
Citation
Hudson CC, McDonald B, Hudson JK, Tran D, Boodhwani M. Impact of anesthetic handover on mortality and morbidity in cardiac surgery: a cohort study. J Cardiothorac Vasc Anesth. 2015 Feb;29(1):11-6. doi: 10.1053/j.jvca.2014.05.018. Epub 2014 Nov 24.
Results Reference
background
PubMed Identifier
29318277
Citation
Jones PM, Cherry RA, Allen BN, Jenkyn KMB, Shariff SZ, Flier S, Vogt KN, Wijeysundera DN. Association Between Handover of Anesthesia Care and Adverse Postoperative Outcomes Among Patients Undergoing Major Surgery. JAMA. 2018 Jan 9;319(2):143-153. doi: 10.1001/jama.2017.20040.
Results Reference
background
PubMed Identifier
30820749
Citation
Liu GY, Su X, Meng ZT, Cui F, Li HL, Zhu SN, Wang DX. Handover of anesthesia care is associated with an increased risk of delirium in elderly after major noncardiac surgery: results of a secondary analysis. J Anesth. 2019 Apr;33(2):295-303. doi: 10.1007/s00540-019-02627-3. Epub 2019 Feb 28.
Results Reference
background
PubMed Identifier
25794111
Citation
Hyder JA, Bohman JK, Kor DJ, Subramanian A, Bittner EA, Narr BJ, Cima RR, Montori VM. Anesthesia Care Transitions and Risk of Postoperative Complications. Anesth Analg. 2016 Jan;122(1):134-44. doi: 10.1213/ANE.0000000000000692.
Results Reference
background
PubMed Identifier
10610649
Citation
Kraman SS, Hamm G. Risk management: extreme honesty may be the best policy. Ann Intern Med. 1999 Dec 21;131(12):963-7. doi: 10.7326/0003-4819-131-12-199912210-00010.
Results Reference
background
PubMed Identifier
18628218
Citation
Berkenstadt H, Haviv Y, Tuval A, Shemesh Y, Megrill A, Perry A, Rubin O, Ziv A. Improving handoff communications in critical care: utilizing simulation-based training toward process improvement in managing patient risk. Chest. 2008 Jul;134(1):158-62. doi: 10.1378/chest.08-0914.
Results Reference
background
PubMed Identifier
19059181
Citation
Wayne JD, Tyagi R, Reinhardt G, Rooney D, Makoul G, Chopra S, Darosa DA. Simple standardized patient handoff system that increases accuracy and completeness. J Surg Educ. 2008 Nov-Dec;65(6):476-85. doi: 10.1016/j.jsurg.2008.06.011.
Results Reference
background
PubMed Identifier
19368073
Citation
The Joint Commission releases Improving America's Hospitals: The Joint Commission's Annual Report on Quality and Safety, 2008. Jt Comm Perspect. 2009 Jan;29(1):3, 5. No abstract available.
Results Reference
background
PubMed Identifier
18817559
Citation
Ferran NA, Metcalfe AJ, O'Doherty D. Standardised proformas improve patient handover: Audit of trauma handover practice. Patient Saf Surg. 2008 Sep 25;2:24. doi: 10.1186/1754-9493-2-24.
Results Reference
background
PubMed Identifier
19269930
Citation
Riesenberg LA, Leitzsch J, Little BW. Systematic review of handoff mnemonics literature. Am J Med Qual. 2009 May-Jun;24(3):196-204. doi: 10.1177/1062860609332512. Epub 2009 Mar 5.
Results Reference
background
PubMed Identifier
19144931
Citation
Haynes AB, Weiser TG, Berry WR, Lipsitz SR, Breizat AH, Dellinger EP, Herbosa T, Joseph S, Kibatala PL, Lapitan MC, Merry AF, Moorthy K, Reznick RK, Taylor B, Gawande AA; Safe Surgery Saves Lives Study Group. A surgical safety checklist to reduce morbidity and mortality in a global population. N Engl J Med. 2009 Jan 29;360(5):491-9. doi: 10.1056/NEJMsa0810119. Epub 2009 Jan 14.
Results Reference
background
PubMed Identifier
29231091
Citation
Shah AC, Oh DC, Xue AH, Lang JD, Nair BG. An electronic handoff tool to facilitate transfer of care from anesthesia to nursing in intensive care units. Health Informatics J. 2019 Mar;25(1):3-16. doi: 10.1177/1460458216681180. Epub 2016 Dec 1.
Results Reference
background
PubMed Identifier
28504990
Citation
Hall M, Robertson J, Merkel M, Aziz M, Hutchens M. A Structured Transfer of Care Process Reduces Perioperative Complications in Cardiac Surgery Patients. Anesth Analg. 2017 Aug;125(2):477-482. doi: 10.1213/ANE.0000000000002020.
Results Reference
background
PubMed Identifier
21037475
Citation
Kalkman CJ. Handover in the perioperative care process. Curr Opin Anaesthesiol. 2010 Dec;23(6):749-53. doi: 10.1097/ACO.0b013e3283405ac8.
Results Reference
background
PubMed Identifier
17474955
Citation
Catchpole KR, de Leval MR, McEwan A, Pigott N, Elliott MJ, McQuillan A, MacDonald C, Goldman AJ. Patient handover from surgery to intensive care: using Formula 1 pit-stop and aviation models to improve safety and quality. Paediatr Anaesth. 2007 May;17(5):470-8. doi: 10.1111/j.1460-9592.2006.02239.x.
Results Reference
background
PubMed Identifier
23173180
Citation
Philibert I, Barach P. The European HANDOVER Project: a multi-nation program to improve transitions at the primary care--inpatient interface. BMJ Qual Saf. 2012 Dec;21 Suppl 1:i1-6. doi: 10.1136/bmjqs-2012-001598. No abstract available.
Results Reference
background
PubMed Identifier
22361791
Citation
Wohlauer MV, Arora VM, Horwitz LI, Bass EJ, Mahar SE, Philibert I; Handoff Education and Assessment for Residents (HEAR) Computer Supported Cooperative Workgroup. The patient handoff: a comprehensive curricular blueprint for resident education to improve continuity of care. Acad Med. 2012 Apr;87(4):411-8. doi: 10.1097/ACM.0b013e318248e766.
Results Reference
background
PubMed Identifier
21173696
Citation
Arriaga AF, Elbardissi AW, Regenbogen SE, Greenberg CC, Berry WR, Lipsitz S, Moorman D, Kasser J, Warshaw AL, Zinner MJ, Gawande AA. A policy-based intervention for the reduction of communication breakdowns in inpatient surgical care: results from a Harvard surgical safety collaborative. Ann Surg. 2011 May;253(5):849-54. doi: 10.1097/SLA.0b013e3181f4dfc8.
Results Reference
background
PubMed Identifier
22435231
Citation
Petrovic MA, Martinez EA, Aboumatar H. Implementing a perioperative handoff tool to improve postprocedural patient transfers. Jt Comm J Qual Patient Saf. 2012 Mar;38(3):135-42. doi: 10.1016/s1553-7250(12)38018-5.
Results Reference
background
PubMed Identifier
25731674
Citation
Pugel AE, Simianu VV, Flum DR, Patchen Dellinger E. Use of the surgical safety checklist to improve communication and reduce complications. J Infect Public Health. 2015 May-Jun;8(3):219-25. doi: 10.1016/j.jiph.2015.01.001. Epub 2015 Feb 26.
Results Reference
background
PubMed Identifier
10720368
Citation
Gaba DM. Anaesthesiology as a model for patient safety in health care. BMJ. 2000 Mar 18;320(7237):785-8. doi: 10.1136/bmj.320.7237.785. No abstract available.
Results Reference
background
PubMed Identifier
15273542
Citation
Dindo D, Demartines N, Clavien PA. Classification of surgical complications: a new proposal with evaluation in a cohort of 6336 patients and results of a survey. Ann Surg. 2004 Aug;240(2):205-13. doi: 10.1097/01.sla.0000133083.54934.ae.
Results Reference
background

Learn more about this trial

Anesthesia-handover Checklist and Perioperative Outcomes in Elderly

We'll reach out to this number within 24 hrs