Clinical trial NCT04955288: Research on Key Technologies and System Optimization of Early Warning and Resuscitation of Cardiac Arrest
Official title: Research on Key Technologies and System Optimization of Early Warning and Resuscitation of Cardiac Arrest
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Emergencies
Keywords: 5G
Aortic Balloon Occlusion Catheter
Esophageal cooling device
Cardiopulmonary resuscitation
Lead sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University
Sponsor class: OTHER
First posted: 2021-07-08
Enrollment: 1000
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: Studies have shown that early prevention and warning of cardiac arrest, rapid implementation of high-quality cardiopulmonary resuscitation, and strengthening of organ function protection after resuscitation are the keys to reducing the occurrence of cardiac arrest and improving the prognosis of patients. However, there are still many problems in the field of cardiopulmonary resuscitation in my country: 1) lack of effective prevention and early self-rescue system for cardiac arrest; 2) traditional resuscitation techniques implemented in pre-hospital and emergency rooms and poor results; 3) organs after resuscitation Insufficient protection means and effects. In our early stage, focusing on the above key issues, the study found that 5G technology can help high-risk emergency events including early warning, early detection and first aid of cardiac arrest. Aortic balloon occlusion can significantly improve the effectiveness of cardiopulmonary resuscitation. Transesophageal and CRRT cooling Can significantly optimize the organ protection intensity of therapeutic hypothermia. On the basis of the preliminary work, this project will carry out the research and development and clinical application of a series of new technologies for cardiac arrest warning and resuscitation, and work hard to help with cardiac arrest. Early warning and treatment of cases provide a set of optimized diagnosis and treatment technical solutions, which has important scientific, clinical and social significance.

Detailed description: 1. During the period from January 2022 to December 2023, based on the early warning and emergency response system of cardiac arrest, real-time monitoring of the vital information of the recruited high-risk populations of cardiac arrest, and timely reporting of the above-mentioned populations with unstable vital signs Distribute early warning information, contact community doctors to provide medical assistance, 120 emergency centers for referrals, and hospitals to prepare for admission, etc., in order to reduce the occurrence of cardiac arrest in high-risk groups; ②January 2022-December 2023 During the period, when a cardiac arrest event occurred in the recruited population based on the above-mentioned system, the nearby social volunteers, community doctors, and 120 emergency centers were quickly activated. Rescue team members quickly went to rescue, and at the same time realized experts' real-time observation and guidance of on-site treatment scenes through the remote consultation system, and prepared for continuous treatment in the hospital, in order to improve the effect of resuscitation and treatment of cardiac arrest in high-risk populations; ③analyze the above Within 2 years of application of the system, the incidence of cardiac arrest and the outcome of early resuscitation and treatment in the recruited high-risk population.
2. Selected patients with cardiac arrest in our hospital from January 2022 to December 2023. Selection criteria: a. 18-75 years old, no gender limit; b. Advanced life support; c. Meet ethical requirements and sign informed consent. Exclusion criteria: a. Refusal of cardiopulmonary resuscitation; b. Indications of non-resuscitation for traumatic cardiac arrest; c. Patients with terminal malignant tumors or other diseases. The patients undergoing cardiac arrest were randomly divided into the traditional cardiopulmonary resuscitation group and the aortic balloon-assisted resuscitation group. The former adopts the traditional chest compression mode, and the latter uses aortic balloon blockade on the basis of the traditional resuscitation mode. Technology, compare the resuscitation effects of patients with cardiac arrest in our hospital within 2 years, such as the duration of cardiopulmonary resuscitation, the amount of adrenaline, the number of defibrillation, the success rate of resuscitation, the survival rate of admission, etc., to clarify that aortic balloon occlusion can improve the effectiveness of cardiopulmonary resuscitation Significant role in.
3. Selected patients with cardiac arrest in our hospital from January 2022 to December 2023. Selection criteria: a. 18 to 75 years old, no gender limit; b. return to spontaneous circulation; c. coma; d. meet ethical requirements and sign informed consent. Exclusion criteria: a. Cardiac arrest time\> 10 min; b. Cardiopulmonary resuscitation time\> 60 min; c. Hemodynamics need to be maintained by high-dose vasoactive drugs (adrenaline or norepinephrine dosage\> 1μg/kg.min); d. The state of dying; e. Patients with advanced malignant tumors or other end-stage diseases. Cardiac arrest patients who had obtained spontaneous circulation were randomly divided into traditional cooling group and esophageal cooling group, respectively, as soon as possible after resuscitation, using body surface cooling blanket device and esophageal cooling device to implement sub-hypothermia, and compare the effect of low-temperature implementation in patients within 2 years, such as the start time, Target length, maintenance of low temperature, rewarming and other indicators, as well as clinical prognostic indicators such as multiple organ dysfunction, adverse events, ICU length of stay, total length of stay, immediate discharge and neurological prognosis and survival at 1, 3, and 6 months In order to clarify the strong protective effect of optimal implementation of therapeutic mild hypothermia through the esophagus on multiple organ damage after resuscitation.

Eligibility criteria: Inclusion Criteria:

18-75 years old Provide advanced life support Meet ethical requirements and sign informed consent return to spontaneous circulation coma

Exclusion Criteria:

Refusal of cardiopulmonary resuscitation Indications of non-resuscitation in the presence of traumatic cardiac arrest Patients with terminal malignant tumors or other diseases Cardiac arrest time\>10min Cardiopulmonary resuscitation time\>60min Hemodynamics need to be maintained by large doses of vasoactive drugs (adrenaline or norepinephrine dosage\>1μg/kg.min) On the verge of Death status Patients with advanced malignant tumors or other end-stage diseases

Primary outcomes:
measure: return of spontaneous circulation (ROSC)
timeFrame: 1-3 hours
Secondary outcomes:
Other outcomes:
measure: survival to discharge
timeFrame: 2 days
measure: survival to discharge without severe neurological impairment
timeFrame: 2 days
measure: 1-month survival without severe neurological impairment
timeFrame: 1 months
measure: 6-month survival without severe neurological impairment
timeFrame: 6 months
measure: insertion-related complications
timeFrame: 2 days
Locations:
city: Hangzhou
country: China
facility: Second Affiliated Hospital, Zhejiang University School of Medicine & Institute of Emergency Medicine, Zhejiang University
state: Zhejiang
Study officials:
affiliation: Second Affiliated Hospital of Zhejiang University School of Medicine
name: Mao Zhang, PHD
role: STUDY_CHAIR
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