- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02884271
Cardiopulmonary Resuscitation in Operating Room (CPR)
February 16, 2024 updated by: Sule Ozbilgin, Dokuz Eylul University
Intraoperative Cardiac Arrest: Incidence and Outcome
In the last ten years patient safety during routine surgical interventions has increased; however as there is an increase in the number of specialized surgical interventions and high risk patients like elderly and emergency patients, the incidence of perioperative cardiac arrest has not reduced but remains fixed.
The incidence of perioperative cardiac arrest varies from 4.3-34.6 for each 10,000 procedures.
However as in a lot of other countries exact data are lacking also for Turkey.
With this study the investigators want to start collecting data about intraoperative cardiac arrest in Turkey, starting at their institution The aim is to evaluate the incidence and outcome in the study.
Secondary aim is to assess the causes of cardiac arrest in the operating room.
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
Detailed Description
Patient information will be collected on a form entitled "Data collection form" including all medications and interventions during cardiopulmonary resuscitation and routine daily used anesthesia registration form.
Study Type
Observational
Enrollment (Estimated)
7
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
- Name: Bahar Kuvaki, Professor
- Phone Number: 902324122836
- Email: bkuvaki@gmail.com
Study Contact Backup
- Name: Sule Ozbilgin, MD
- Phone Number: 905055252901
- Email: ozbilginsule@gmail.com
Study Locations
-
-
-
İzmir, Turkey, 35340
- Recruiting
- Dokuz Eylül University, School of Medicine, Department of Anesthesiology and Reanimation
-
Contact:
- Bahar Kuvaki, Professor
- Phone Number: 902324122836
- Email: bkuvaki@gmail.com
-
Contact:
- Sule Ozbilgin, MD
- Phone Number: 905055252901
- Email: ozbilginsule@gmail.com
-
-
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
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Sampling Method
Non-Probability Sample
Study Population
This study will include all patients who develop cardiac arrest in the operating room (including preoperative waiting area and postoperative recovery unit) Dokuz Eylul University Hospital.
Description
Inclusion Criteria:
- All patients who develop cardiac arrest in the operating room
Exclusion Criteria:
- Absence of informed consent
- Patients arriving into the operating room with ongoing CPR
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 |
Intervention / Treatment |
---|---|
cardiac arrest group
patients who develop intraoperative cardiac arrest
|
start cardiopulmonary resuscitation
|
without cardiac arrest group
patients who don't develop intraoperative cardiac arrest
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
incidence of intraoperative cardiac arrest
Time Frame: baseline
|
baseline
|
neurologic outcome of patients according to Cerebral performance category scale
Time Frame: until six months after return of spontaneous circulation
|
until six months after return of spontaneous circulation
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
causes of intraoperative cardiac arrest among participants/patients
Time Frame: baseline
|
Probable causes of intraoperative cardiac arrest among participants/patients
|
baseline
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Bahar Kuvaki, Professor, Dokuz Eylül University, School of Medicine, Department of Anesthesiology and Reanimation
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 (Actual)
March 1, 2016
Primary Completion (Estimated)
December 1, 2026
Study Completion (Estimated)
May 1, 2027
Study Registration Dates
First Submitted
August 17, 2016
First Submitted That Met QC Criteria
August 29, 2016
First Posted (Estimated)
August 30, 2016
Study Record Updates
Last Update Posted (Actual)
February 20, 2024
Last Update Submitted That Met QC Criteria
February 16, 2024
Last Verified
February 1, 2024
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2482-GOA
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
YES
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
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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