An interventional study of Aortic balloon assisted resuscitation and Traditional cardiopulmonary resuscitation in Emergencies, sponsored by Second Affiliated Hospital, School of Medicine, Zhejiang University. Status unknown at 1 site in China. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2021-07-08.
Sponsored by Second Affiliated Hospital, School of Medicine, Zhejiang University · Not applicable, Interventional, and Other
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.
966 studies on the registry are indexed under Heart Arrest; 227 are open to participants now.
This study's planned enrollment of 1,000 is above the median of 100 across 557 interventional studies indexed under Heart Arrest.
Browse Heart Arrest studies →Second Affiliated Hospital, School of Medicine, Zhejiang University is the lead sponsor of 1,058 studies on the registry; 511 are open to participants now.
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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
The aortic balloon-assisted resuscitation group uses aortic balloon occlusion technology on the basis of the traditional resuscitation mode, that is, when the cardiopulmonary resuscitation begins, the aortic balloon catheter is quickly punctured and inserted to the distal end of the aortic area I via ultrasound. (Septum level), 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.
Procedure: Aortic balloon assisted resuscitation
The traditional cardiopulmonary resuscitation group uses the traditional manual chest compression mode, that is, referring to the latest version of the cardiopulmonary resuscitation guidelines, manual chest compressions are performed under the monitoring of the compression quality feedback device to ensure that the compression depth is 5-6cm, the frequency is 100-120 times/min, Conditions such as a fixed compression position and sufficient chest wall rebound.
Procedure: Traditional cardiopulmonary resuscitation
The esophageal cooling group adopts a new transesophageal cooling method, that is, an esophageal cooling catheter is placed after resuscitation in patients with cardiac arrest, and then a small temperature-controlled water circulation system is continuously perfused with 4℃ cold water. After the patient's body temperature reaches the target temperature of 33℃, the temperature is adjusted Control the water circulation system to maintain the target body temperature of (33±0.5)°C for 24 hours, and then reheat to (37±0.5)°C normal body temperature at a rate of 0.25-0.5°C/h and maintain it for 24 hours.
Procedure: Esophageal cooling
The traditional cooling group uses the traditional body surface ice blanket cooling method, that is, the patients with cardiac arrest lie on the temperature control blanket after resuscitation, and then use 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℃ After that, adjust the ice blanket host to control the circulating water temperature 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.
Procedure: traditional cooling
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.
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.
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.
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.
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).
Time frame: 1-3 hours
survival to discharge
whether patients survive to hospital discharge
Time frame: 2 days
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.
Time frame: 2 days
1-month survival without severe neurological impairment
patients who have survived for 1 month after cardiac arrest with a CPC score of 1\~2
Time frame: 1 months
6-month survival without severe neurological impairment
patients who have survived for 6 months after cardiac arrest with a CPC score of 1\~2
Time frame: 6 months
insertion-related complications
Whether esophageal mucosal injury,aortic injury,or some other complications occur in patients
Time frame: 2 days
Plan to share: No
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Second Affiliated Hospital, School of Medicine, Zhejiang University