Intraoperative Cardiac ArrestCPRNCT02884271
Cardiopulmonary Resuscitation in Operating Room
An observational study of Intraoperative Cardiac Arrest, run by Dokuz Eylul University at 1 site in Turkey (Türkiye).
Trial summary
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Intraoperative Cardiac Arrest
- What is being tested?
- cardiopulmonary resuscitation
- Type of treatment
- Surgery or procedure
- How many people
- 7 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- Mar 2016to May 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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.
Who may be able to join
- All patients who develop cardiac arrest in the operating room
Who cannot join
- Absence of informed consent
- Patients arriving into the operating room with ongoing CPR
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Dokuz Eylül University, School of Medicine, Department of Anesthesiology and Reanimation
Izmir, 35340
Bahar Kuvaki, Professor, 902324122836, bkuvaki@gmail.com
Sule Ozbilgin, MD, 905055252901, ozbilginsule@gmail.com
About this study
Official title: 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.
Read the 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.
- Conditions
- Intraoperative Cardiac Arrest
- Being tested
- cardiopulmonary resuscitation
- Keywords
- CPR, cardiac arrest, operating room
- Medical subject headings
- Heart Arrest
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cardiopulmonary resuscitationProcedure or surgery
start cardiopulmonary resuscitation
| Study group | Role | What they receive |
|---|---|---|
| cardiac arrest group | patients who develop intraoperative cardiac arrest Receives: Procedure: cardiopulmonary resuscitation | |
| without cardiac arrest group | patients who don't develop intraoperative cardiac arrest |
What is being measured
The primary outcome is the main question the study is designed to answer.
incidence of intraoperative cardiac arrest
Measured: baseline
neurologic outcome of patients according to Cerebral performance category scale
Measured: until six months after return of spontaneous circulation
Secondary outcomes (1)
causes of intraoperative cardiac arrest among participants/patients
Probable causes of intraoperative cardiac arrest among participants/patients
- Trauma
- End stage liver disease and complications associated with liver transplantation
- Unable to wean from cardiopulmonary bypass
- Complications associated with cardiac surgery
- Ruptured aneurysm; abdominal or thoracic
- Technical complications: surgical and special procedures, central venous access
- Complications associated with automatic implantable cardiac defibrillator placement
- Hemorrhage
- Complications associated with radical cancer surgery
- Sepsis and multiple organ failure
- Perioperative myocardial infarction
- Complications associated with congenital heart defect
- Complications associated with neurosurgery
- Complications associated with Anaesthesia (anaphylaxis, difficult airway management/difficult ventilation, adverse drug, total spinal anaesthesia/bloc etc)
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Aug 2016 (estimated)
- Study startMar 2016
- Primary completionDec 2026 (estimated)
- Study completionMay 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intraoperative Cardiac ArrestStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 7 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Dokuz Eylul University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sule Ozbilgin, Dokuz Eylul University
- Investigators
- Bahar Kuvaki, Professor, Principal investigator, Dokuz Eylül University, School of Medicine, Department of Anesthesiology and Reanimation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02884271
- Sponsor's protocol ID
- 2482-GOA
- Acronym
- CPR
- Status last verified
- Feb 2024
- First submitted
- 17 Aug 2016
- Last updated
- 20 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intraoperative Cardiac Arrest: Incidence and Outcome
- ClinicalTrials.gov ID
- NCT02884271
- Acronym / sponsor ID
- CPR / 2482-GOA
- Conditions
- Intraoperative Cardiac Arrest
- Keywords
- CPR, cardiac arrest, operating room
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 7 participants (estimated)
- Lead sponsor
- Dokuz Eylul UniversityUniversity, hospital or other
- Study start
- Mar 2016 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- May 2027 (estimated)
- First posted
- 30 Aug 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| cardiac arrest group | – | Procedure: cardiopulmonary resuscitationpatients who develop intraoperative cardiac arrest |
| without cardiac arrest group | – | –patients who don't develop intraoperative cardiac arrest |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- All patients who develop cardiac arrest in the operating room
Key exclusion criteria (2 listed)
- Absence of informed consent
- Patients arriving into the operating room with ongoing CPR
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| cardiopulmonary resuscitationstart cardiopulmonary resuscitation | Procedure or surgery | cardiac arrest group |
Primary outcome
incidence of intraoperative cardiac arrest
Time frame: baseline
neurologic outcome of patients according to Cerebral performance category scale
Time frame: until six months after return of spontaneous circulation
1 secondary outcome
causes of intraoperative cardiac arrest among participants/patients
Time frame: baseline
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Feb 2024.
- Individual participant dataSharing planned: Yes
Related trials for Intraoperative Cardiac Arrest
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Anesthesia for Catheter Aortic Valve ImplantATIOn Registry
Heart Failure, Excessive Amount of Blood / Fluid Transfusion
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Bahar Kuvaki, Professor principal investigator
Dokuz Eylül University, School of Medicine, Department of Anesthesiology and Reanimation
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Intraoperative Cardiac Arrest, run by Dokuz Eylul University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 20 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Bahar Kuvaki, Professor (902324122836, bkuvaki@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
incidence of intraoperative cardiac arrest (time frame: baseline). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Feb 2024.