- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02453828
Intraoperative Anesthesia Care Transition Checklist
The Effects of Implementing an Anesthesia Information Management System Guided Intraoperative Anesthesia Care Transition Checklist on Postoperative Complications: A Randomized Trial
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
The modern team-based approached to patient care often involves transitioning care between providers. Critical details may be lost during transition, or handovers, resulting in delays, inefficiencies, suboptimal care, or even patient harm. The Joint Commission on Hospital Accreditation declared that communication failures are the root cause of almost two-thirds of all sentinel events. The World Health Organization similarly listed "communication during patient care handover" as one of the highest patient safety initiatives. The consequence of ineffectual communication may be especially detrimental during surgery when patients are often unstable and post-handover decisions must be made quickly and accurately. In a preliminary study the investigators observed an 8% increase in odds of experiencing major in-hospital morbidity or mortality per for each intraoperative handover.
Checklists have been used for transitions of care in a variety of areas; orthopedic trauma, urological robotic surgeries, and emergency departments. The field of anesthesia has also embraced the use of checklists, especially in the handover to intensive care units. Post-anesthesia checklists have been the particular focus of anesthesia providers in recent years. Post-operative checklists clearly enhance information transfer, but have only been evaluated using historical controls which do not account for bias. The anesthesia area most lacking valid studies is intraoperative handovers.
Anesthesia-specific intraoperative handovers differ because the interaction is primarily between anesthesia providers while surgery continues without disruption. To date, there has only been one proposed checklist for intraoperative handovers between anesthesia providers and it has not been prospectively evaluated. A randomized study with contemporaneous controls, utilizing an anesthesia specific, electronically pre-populated checklist measuring objective "hard" outcomes will address the limitations of previous studies.
The investigators propose to test the hypothesis that incorporating an electronic handover checklist during transitions of intraoperative anesthesia care reduces serious complications. Specifically, the investigators will quantify the effect of a handover checklist on adverse outcomes as defined by a composite of mortality and serious cardiovascular, respiratory, gastrointestinal, urinary, and infectious complications.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Ohio
-
Cleveland, Ohio, United States, 44195
- Cleveland Clinic Foundation
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- non-cardiac surgery
Exclusion Criteria:
- under 18 years of age
Study Plan
How is the study designed?
Design Details
- Primary Purpose: SUPPORTIVE_CARE
- Allocation: RANDOMIZED
- Interventional Model: SINGLE_GROUP
- Masking: DOUBLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Checklist
after non-cardiac surgery, patients will have current standard-of-care anesthesia handover during anesthesia transitions in care with an additional, electronically pre-populated checklist displayed on the anesthesia record keeping system
|
patients having non-cardiac surgery
|
Active Comparator: Standard of Care
after non-cardiac surgery, patients will have current standard-of-care anesthesia handover during anesthesia transitions in care
|
patients having non-cardiac surgery
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
a composite of in-hospital mortality and 6 major morbidities including serious cardiac, respiratory, gastrointestinal, urinary, bleeding, and infectious complications
Time Frame: 5 days
|
5 days
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Leif Saager, M.D., The Cleveland Clinic
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 15-192
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.
Clinical Trials on Postoperative Complications
-
Marmara UniversityHacettepe University; Cukurova University; Gazi University; Baskent University; Istanbul... and other collaboratorsNot yet recruitingComplications, PostoperativeTurkey
-
Syed HusainRecruitingComplications, PostoperativeUnited States
-
University of PittsburghCompletedLiver Transplant; Complications | Perioperative/Postoperative ComplicationsUnited States
-
Vastra Gotaland RegionRecruitingSurgery | Lung Infection | Complications, PostoperativeSweden
-
Washington University School of MedicineNational Institute of Nursing Research (NINR)CompletedSurgery | Surgery--Complications | Perioperative/Postoperative ComplicationsUnited States
-
Wake Forest University Health SciencesTerminatedPerioperative/Postoperative ComplicationsUnited States
-
Technical University of MunichHealth Information Management, BelgiumActive, not recruitingPerioperative/Postoperative Complications
-
Atatürk Chest Diseases and Chest Surgery Training...CompletedPerioperative/Postoperative ComplicationsTurkey
-
Namigar TurgutCompletedPerioperative/Postoperative ComplicationsTurkey
-
TC Erciyes UniversityCompletedPerioperative/Postoperative ComplicationsTurkey
Clinical Trials on Non-cardiac surgery
-
Second Hospital of Shanxi Medical UniversityRecruitingType 2 Diabetes | NeuropathyChina
-
McMaster UniversityRecruitingPostoperative Pain | Postoperative Cognitive Dysfunction | Depressive SymptomsCanada
-
Université Libre de BruxellesCHU de CharleroiCompleted
-
University of British ColumbiaUniversity of OttawaActive, not recruiting
-
The Cleveland ClinicCompletedPostoperative ComplicationsUnited States
-
Beijing Friendship HospitalNot yet recruitingPostoperative Delirium | Preoperative Anxiety | Inflammatory Reaction | Preoperative Sleep Disorder
-
Seoul National University HospitalCompletedAcute Coronary Syndrome | Aspirin | Drug-eluting StentKorea, Republic of
-
University of CalgaryRecruitingMinimally Invasive Cardiac Valvular SurgeryCanada
-
Aarhus University Hospital SkejbyTerminatedPain, Postoperative | Heart Surgery | Effusion Pleural | Chest TubeDenmark
-
Cardiovascular Research New BrunswickHorizon Health Network; Maritime Heart CentreActive, not recruitingObesity | Cardiac Disease | Cardiovascular Syndromes, MetabolicCanada