Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 2 of 2 for:    25372088 [PUBMED-IDS]

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03597932
Recruitment Status : Not yet recruiting
First Posted : July 24, 2018
Last Update Posted : July 24, 2018
Sponsor:
Collaborator:
Zhejiang Provincial Tongde Hospital
Information provided by (Responsible Party):
xiangming fang, First Affiliated Hospital of Zhejiang University

Brief Summary:
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.

Condition or disease Intervention/treatment
Anesthesia Surgery--Complications Burnout, Professional Device: standardized handover checklist

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.

Layout table for study information
Study Type : Observational [Patient Registry]
Estimated Enrollment : 3342 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 90 Days
Official Title: Intraoperative Handover Checklist of Anesthesia Care Improves Postoperative Outcomes Among Patients Undergoing Major Surgery: a Multicenter, Before-after Cohort Study
Estimated Study Start Date : August 1, 2018
Estimated Primary Completion Date : August 11, 2018
Estimated Study Completion Date : February 28, 2019

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
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.




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. Incidence of 7 day-, 30 day-, 90 day- and inhospital mortality [ Time Frame: 7/30/90 day ]
    7/30/90-day mortality, inhospital mortality

  2. Incidence of major complications [ Time Frame: 30 days ]
    Postoperative major complications, defined by International Classification of Diseases, Tenth Revision (ICD-10) diagnostic codes

  3. Incidence of ICU admission post surgery [ Time Frame: 30 days ]
    Incidence of postoperative intensive care unit (ICU) admission, ,within 30 days post surgery

  4. The time of hospital length of stay (LOS) [ Time Frame: up to 30 days ]
    Hospital length of stay (LOS)

  5. Incidence of emergency department (ED) visits [ Time Frame: 90 days ]
    Emergency department (ED) visits within 90 days of the index surgery

  6. Any medical cost during hospital stay [ Time Frame: up to 90 days ]
    Any medical cost during hospital stay

  7. Ventilation time within postoperative 30 days [ Time Frame: Up to 30 days ]
    Ventilation time within postoperative 30 days

  8. Anaesthetic resuscitation time [ Time Frame: Up to 24 hours ]
    Anaesthetic resuscitation time after the surgery is completed



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Criteria

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.

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): NCT03597932


Contacts
Layout table for location contacts
Contact: Ye Hui +8615267048716 yehui@zju.edu.cn
Contact: Cheng Baoli +8613777479235 chengbaoli1979@zju.edu.cn

Sponsors and Collaborators
First Affiliated Hospital of Zhejiang University
Zhejiang Provincial Tongde Hospital
Investigators
Layout table for investigator information
Principal Investigator: Fang Xiangming first affilated hospital of zhejiang university

Additional Information:
Publications of Results:

Layout table for additonal information
Responsible Party: xiangming fang, Director, Head of Anesthesiology and Critical Care, Principal Investigator, Professor, First Affiliated Hospital of Zhejiang University
ClinicalTrials.gov Identifier: NCT03597932     History of Changes
Other Study ID Numbers: xfang
First Posted: July 24, 2018    Key Record Dates
Last Update Posted: July 24, 2018
Last Verified: July 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: Share all the data after the first article was published on issue

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by xiangming fang, First Affiliated Hospital of Zhejiang University:
major surgery
ansethesia care
postoperative complication
handover checklist
anesthesiologist burnout

Additional relevant MeSH terms:
Layout table for MeSH terms
Burnout, Psychological
Burnout, Professional
Stress, Psychological
Behavioral Symptoms
Occupational Stress
Occupational Diseases
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs