Research on Key Technologies and System Optimization of Early Warning and Resuscitation of Cardiac Arrest

Emergencies Clinical Trial

Official title:

Research on Key Technologies and System Optimization of Early Warning and Resuscitation of Cardiac Arrest

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04955288
• Other study ID #: 2021-0420
• Status: Recruiting
• Phase: N/A
• Start date: January 1, 2021
• Est. completion date: November 30, 2024

Study information

• Verified date: June 2021
• Source: Second Affiliated Hospital, School of Medicine, Zhejiang University
• Contact: Mao Zhang, PHD
• Phone: 86-571-87784654
• Email: z2jzk[@]zju.edu.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1000
• Est. completion date: November 30, 2024
• Est. primary completion date: December 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Emergencies
• Heart Arrest

Intervention

Procedure:
• Aortic balloon assisted resuscitation
On the basis of the traditional resuscitation mode, the aortic balloon occlusion technology is used, that is, at the same time when the cardiopulmonary resuscitation starts, the aortic balloon catheter is quickly punctured to the distal end of the aortic zone I (septum level) through ultrasound assistance, and then Continue to inflate the balloon to block the aortic blood flow until the end of the cardiopulmonary resuscitation to deflate the balloon and remove the balloon catheter.
• Traditional cardiopulmonary resuscitation
Use the traditional manual chest compression mode, that is, refer to the latest version of the CPR Guidelines. Artificial chest compressions are performed under the monitoring of the pressure quality feedback device to ensure that the compression depth is 5-6cm, the frequency is 100-120 times/min, the compression position is fixed, and the chest wall fully rebounds.
• Esophageal cooling
The new transesophageal cooling method is adopted, that is, the esophageal cooling catheter is indwelled after resuscitation in patients with cardiac arrest, and then connected to a small temperature-controlled water circulation system to continuously infuse 4? cold water. After the patient's body temperature reaches the target temperature of 33?, the temperature-controlled water circulation system is adjusted Maintain the target body temperature of (33±0.5)°C for 24 hours, and then rewarm to (37±0.5)°C normal body temperature at a rate of 0.25-0.5°C/h and maintain it for 24 hours.
• traditional cooling
The traditional body surface ice blanket cooling method is adopted, that is, the patient with cardiac arrest lies on the temperature control blanket after resuscitation, and then uses the ice blanket host to continuously infuse the temperature control blanket with 4? cold water, and wait until the patient's body temperature reaches the target temperature of 33?. The temperature of the circulating water is controlled by adjusting the ice blanket host to maintain the target body temperature of (33±0.5)°C for 24 hours, and then reheat to the normal body temperature of (37±0.5)°C at a rate of 0.25-0.5°C/h and maintain it for 24 hours.

Locations

Country	Name	City	State
China	Second Affiliated Hospital, Zhejiang University School of Medicine & Institute of Emergency Medicine, Zhejiang University	Hangzhou	Zhejiang

Sponsors (1)

Lead Sponsor	Collaborator
Second Affiliated Hospital, School of Medicine, Zhejiang University

Country where clinical trial is conducted

China, 

References & Publications (29)

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* Note: There are 29 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	survival to discharge	whether patients survive to hospital discharge	2 days
Other	survival to discharge without severe neurological impairment	defined as a CPC score of 1~2, which denotes survival with no more than moderate neurological disability with the ability to walk without assistance.	2 days
Other	1-month survival without severe neurological impairment	patients who have survived for 1 month after cardiac arrest with a CPC score of 1~2	1 months
Other	6-month survival without severe neurological impairment	patients who have survived for 6 months after cardiac arrest with a CPC score of 1~2	6 months
Other	insertion-related complications	Whether esophageal mucosal injury,aortic injury,or some other complications occur in patients	2 days
Primary	return of spontaneous circulation (ROSC)	ROSC can be identified with the following three conditions: 1. arterial pulse can be reached; 2. effective ECG rhythm; 3. systolic blood pressure > 60 mmHg (1 mm Hg = 0.133 kPa).	1-3 hours