Clinical Trial Details
— Status: Recruiting
Administrative data
| NCT number |
NCT06165081 |
| Other study ID # |
202309123RIND |
| Secondary ID |
|
| Status |
Recruiting |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
January 1, 2024 |
| Est. completion date |
December 31, 2024 |
Study information
| Verified date |
December 2023 |
| Source |
National Taiwan University Hospital |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical Trial Summary
This study examines the impact of emergency department (ED) management on short-term outcomes
of nontraumatic adult out-of-hospital cardiac arrest (OHCA) patients. Conducted by a research
team at National Taiwan University Hospital and its affiliated hospitals, including branches
in Hsinchu and Yunlin, the study spans from January 2016 to August 2023. It focuses on a
sequential population of patients, analyzing data like age, gender, medical history,
prehospital care details (e.g., witnessed collapse, bystander CPR), and specifics of ED
management.
OHCA, with an incidence rate of 50-100 per 100,000 people, presents high mortality and severe
complications, leading to significant healthcare expenditures. After resuscitation in the ED,
only about one-fifth of patients achieve return of spontaneous circulation (ROSC). The
prognosis for these patients remains grim, with a mere 5% experiencing favorable neurological
outcomes. Understanding the mechanisms of OHCA, identifying risk factors, effective
interventions, and the timing of ED treatments like vasopressors and electrocardiography are
crucial.
Patients post-OHCA often undergo a postcardiac arrest syndrome (PCAS), marked by cellular
hypoxia and a consequential inflammatory response. Stability of vital signs and rapid ED
interventions, including identifying OHCA causes and coordinating with specialists, are vital
for short-term recovery. This study aims to determine if ED management and time-related
factors from ROSC to various interventions (e.g., ECG, CT scans) affect short-term survival
rates, including survival to hospital admission and survival after 1, 3, and 7 days.
By retrospectively analyzing patient data, including Utstein Style prehospital cardiac arrest
registry variables and emergency department management details, the study seeks to shed light
on the crucial phase of post-resuscitation care. The ultimate goal is to improve survival
rates and neurological outcomes in OHCA patients, emphasizing the need for more comprehensive
research in this area
Description:
The incidence rate of out-of-hospital cardiac arrest (OHCA) is approximately 50 to 100 per
100,000 people. OHCA has a high mortality rate and severe complications that lead to
substantial healthcare expenditures. After being resuscitated in the Emergency Department
(ED), about one-fifth patients achieve return of spontaneous circulation (ROSC). However,
some patients who survive to hospital admission fail to survive. The rate of favorable
neurological outcomes is also poor, around 5%. To improve survival rates and neurological
outcomes, previous studies focused on understanding the mechanisms of OHCA, identifying risk
factors, finding effective interventions, promoting public education, first aid training, and
implementing treatments such as targeted temperature management and cardiac catheterization.
OHCA patients experience a postcardiac arrest syndrome (PCAS) between cellular hypoxia and
reperfusion, resulting in an inflammatory response in the body. At this stage, patients'
vital signs are typically unstable, and emergency department, including initial
post-resuscitation care, rapid stabilization of patients, identification of the cause of OHCA
and coordination with appropriate specialists, has a significant impact on post-cardiac
arrest short-term outcomes. The timing of ED interventions, including the administration of
vasopressors, 12-lead electrocardiography, inotropes, and the time-consuming from ROSC to
hospital admission, may also influence short-term outcomes. Currently, there is a lack of
comprehensive research on whether ED management affects the short-term outcome in OHCA
patients. This study highlights the need to collect and analyze information in this regard.
This study is a retrospective study, a series study in our study team, focusing on a
sequential population of nontraumatic adult OHCA patients from January 2016 to August 2023
(2016/1/1~2023/8/31) at the National Taiwan University Hospital and its three affiliated
hospitals, including branches in Hsinchu and Yunlin. The research variables include basic
patient information (age, gender, etc.), past medical history, Utstein Style prehospital
cardiac arrest patient registry variables (witnessed collapse, bystander CPR, rhythm,
defibrillation, medications, airway management, etc.), emergency department management and
time intervals (from ROSC to ECG time, from ROSC to CT time), etc. Primary outcomes include
survival to hospital admission, 1-day, 3-day, and 7-day survival rates. This study aims to
investigate whether the management of the emergency department and time series factors
influences the short-term outcomes in patients following OHCA.
