Intraoperative Handover Checklist of Anesthesia Care Improves Outcomes Among Patients Undergoing Major Surgery

July 22, 2018 updated by: xiangming fang, First Affiliated Hospital of Zhejiang University

Intraoperative Handover Checklist of Anesthesia Care Improves Postoperative Outcomes Among Patients Undergoing Major Surgery: a Multicenter, Before-after Cohort Study

Implementation of a standardized handover checklist for intraoperative anesthesia care transition attenuates burnout among anesthesiologists and improves postoperative outcomes of patients undergoing major surgery , both of which benefit the quality of patient care and the development of anesthesiology.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Many retrospective studies have demonstrated that among adults undergoing major surgery, complete handover of intraoperative anesthesia care compared with no handover was associated with a higher risk of adverse postoperative outcomes. Anesthesiologists keeping on working without handovers may experience symptoms of burnout which do not only pose a threat to the mental and physical health of the anesthesiologist, but also result in sub-optimal safety care of patients. Poor-quality handover without standardized processes can lead to diagnostic and therapeutic delays and precipitate adverse events. An improved system of anesthesia standardized handovers using a checklist would improve transfer of information and professional responsibility and therefore lead to the improvement of patient safety as well as burnout among anesthesiologists. Thus it is urgent to develop a standardized handover checklist for intraoperative anesthesia care to improve postoperative outcome of patients.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
3342

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Adult patients aged 18 years and older undergoing major surgeries requiring a hospital stay of at least 1 night are enrolled to use a checklist if they need handover of anesthesia care during surgery process.

Description

Inclusion Criteria:

  • Adult patients aged 18 years and older undergoing major surgeries requiring a hospital stay of at least 1 night are enrolled in this study.

Exclusion Criteria:

  • Adult patients aged less than 18 years undergoing major surgeries and were not requiring a hospital stay of at least 1 night are excluded.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
baseline or control group
All participant anesthesiologists do intraoperative handover of anesthesia care according to a usual process or without checklist for 2-week to 1-month baseline data collection.
Checklist group
All participant anesthesiologists do intraoperative handover of anesthesia care by using a standardized handover checklist for another 2-week to 1-month data collection.
Device: standardized handover checklist
Following a review of relevant literatures and guidelines, a checklist consisting of the various key items necessary for giving continuing and safe intraoperative patient care was designed and validated by anesthesia residents and staff. Following 2-week to 1-month baseline data collection, each anesthesiologists and anesthesia residents in participating hospitals were asked to implement the safe-anesthesia checklist to improve practice over another 2-week to 1-month period. The checklist consists of an oral confirmation and closed-loop communication between the primary anesthesiologist and the replacement anesthesiologist. Evaluation of the effect of implementation of a standardized checklist during anesthesia care handover on patient safety during follow-up.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Incidence of a composite of all-cause death, hospital readmission, or major postoperative complications
Time Frame: 30 days
The primary outcome that will be measured is a composite of all-cause death, hospital readmission, or major postoperative complications, all within 30 days post surgery
30 days

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Incidence of emergency department (ED) visits
Time Frame: 90 days
Emergency department (ED) visits within 90 days of the index surgery
90 days
Incidence of 7 day-, 30 day-, 90 day- and inhospital mortality
Time Frame: 7/30/90 day
7/30/90-day mortality, inhospital mortality
7/30/90 day
Incidence of major complications
Time Frame: 30 days
Postoperative major complications, defined by International Classification of Diseases, Tenth Revision (ICD-10) diagnostic codes
30 days
Incidence of ICU admission post surgery
Time Frame: 30 days
Incidence of postoperative intensive care unit (ICU) admission, ,within 30 days post surgery
30 days
The time of hospital length of stay (LOS)
Time Frame: up to 30 days
Hospital length of stay (LOS)
up to 30 days
Any medical cost during hospital stay
Time Frame: up to 90 days
Any medical cost during hospital stay
up to 90 days
Ventilation time within postoperative 30 days
Time Frame: Up to 30 days
Ventilation time within postoperative 30 days
Up to 30 days
Anaesthetic resuscitation time
Time Frame: Up to 24 hours
Anaesthetic resuscitation time after the surgery is completed
Up to 24 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
First Affiliated Hospital of Zhejiang University

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Zhejiang Provincial Tongde Hospital

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Fang Xiangming, First Affilated Hospital of Zhejiang University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 1, 2018

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 11, 2018

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 28, 2019

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 22, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 22, 2018

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 24, 2018

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 24, 2018

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 22, 2018

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • xfang

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

IPD Plan Description

Share all the data after the first article was published on issue

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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