EmergenciesNCT04955288

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

A study testing Aortic balloon assisted resuscitation, Traditional cardiopulmonary resuscitation and Esophageal cooling in people with Emergencies, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 1 site in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record

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Trial summary

Who is it for?: Ages 18 to 75 years
Conditions the study is for: Emergencies
What is being tested?: Aortic balloon assisted resuscitation, Traditional cardiopulmonary resuscitation and Esophageal cooling
Type of treatment: Surgery or procedure
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 1,000 participants
Where: 1 siteChina
Study dates: 1 Jan 2021to 30 Nov 2024
Phase: Interventional
Are there results?: None posted in the registry

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 18 to 75 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Mao Zhang, PHD contact

86-571-87784654

z2jzk@zju.edu.cn

China1 site, 1 recruiting

Second Affiliated Hospital, Zhejiang University School of Medicine & Institute of Emergency Medicine, Zhejiang University
Hangzhou, Zhejiang, 310009
Mao Zhang, MD, 86-571-87784654, z2jzk@zju.edu.cn
Recruiting

Other trials in China

About this study

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.

Read the detailed description

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.
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.
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.

Conditions: Emergencies
Being tested: Aortic balloon assisted resuscitation, Traditional cardiopulmonary resuscitation, Esophageal cooling, traditional cooling
Keywords: 5G, Aortic Balloon Occlusion Catheter, Esophageal cooling device, Cardiopulmonary resuscitation
Medical subject headings: Emergencies

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Aortic balloon assisted resuscitationProcedure or surgery
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 resuscitationProcedure or surgery
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 coolingProcedure or surgery
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 coolingProcedure or surgery
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.

Study groups in NCT04955288
Study group	Role	What they receive
Aortic balloon Assisted resuscitation group	Experimental	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. Receives: Procedure: Aortic balloon assisted resuscitation
Traditional cardiopulmonary resuscitation group	Active comparator	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. Receives: Procedure: Traditional cardiopulmonary resuscitation
Esophageal cooling group	Experimental	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. Receives: Procedure: Esophageal cooling
Traditional cooling group	Active comparator	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. Receives: Procedure: traditional cooling

What is being measured

The primary outcome is the main question the study is designed to answer.

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).
Measured: 1-3 hours

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Jan 202130 Nov 2024

First posted8 Jul 2021
Study start1 Jan 2021
Primary completion30 Dec 2023 (estimated)
Study completion30 Nov 2024 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (29)Papers the sponsor has linked to this study.
Other trials for EmergenciesStudies 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: Interventional
Phase: Phase N/A
Primary purpose: Other
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 1,000 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04955288
Sponsor's protocol ID: 2021-0420
Status last verified: Jun 2021
First submitted: 20 Jun 2021
Last updated: 8 Jul 2021
Results posted: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

Benjamin EJ, Muntner P, Alonso A, Bittencourt MS, Callaway CW, Carson AP, Chamberlain AM, Chang AR, Cheng S, Das SR, Delling FN, Djousse L, Elkind MSV, Ferguson JF, Fornage M, Jordan LC, Khan SS, Kissela BM, Knutson KL, Kwan TW, Lackland DT, Lewis TT, Lichtman JH, Longenecker CT, Loop MS, Lutsey PL, Martin SS, Matsushita K, Moran AE, Mussolino ME, O'Flaherty M, Pandey A, Perak AM, Rosamond WD, Roth GA, Sampson UKA, Satou GM, Schroeder EB, Shah SH, Spartano NL, Stokes A, Tirschwell DL, Tsao CW, Turakhia MP, VanWagner LB, Wilkins JT, Wong SS, Virani SS; American Heart Association Council on Epidemiology and Prevention Statistics Committee and Stroke Statistics Subcommittee. Heart Disease and Stroke Statistics-2019 Update: A Report From the American Heart Association. Circulation. 2019 Mar 5;139(10):e56-e528. doi: 10.1161/CIR.0000000000000659. No abstract available.
PubMed 30700139
Hawkes C, Booth S, Ji C, Brace-McDonnell SJ, Whittington A, Mapstone J, Cooke MW, Deakin CD, Gale CP, Fothergill R, Nolan JP, Rees N, Soar J, Siriwardena AN, Brown TP, Perkins GD; OHCAO collaborators. Epidemiology and outcomes from out-of-hospital cardiac arrests in England. Resuscitation. 2017 Jan;110:133-140. doi: 10.1016/j.resuscitation.2016.10.030. Epub 2016 Nov 17.
PubMed 27865775
Shao F, Li CS, Liang LR, Li D, Ma SK. Outcome of out-of-hospital cardiac arrests in Beijing, China. Resuscitation. 2014 Nov;85(11):1411-7. doi: 10.1016/j.resuscitation.2014.08.008. Epub 2014 Aug 20.
PubMed 25151546
Weisfeldt ML, Becker LB. Resuscitation after cardiac arrest: a 3-phase time-sensitive model. JAMA. 2002 Dec 18;288(23):3035-8. doi: 10.1001/jama.288.23.3035. No abstract available.
PubMed 12479769
Guidelines 2000 for Cardiopulmonary Resuscitation and Emergency Cardiovascular Care. Part 6: advanced cardiovascular life support: section 1: Introduction to ACLS 2000: overview of recommended changes in ACLS from the guidelines 2000 conference. The American Heart Association in collaboration with the International Liaison Committee on Resuscitation. Circulation. 2000 Aug 22;102(8 Suppl):I86-9. doi: 10.1161/01.cir.102.suppl_1.i-86. No abstract available.
PubMed 10966665
Laver S, Farrow C, Turner D, Nolan J. Mode of death after admission to an intensive care unit following cardiac arrest. Intensive Care Med. 2004 Nov;30(11):2126-8. doi: 10.1007/s00134-004-2425-z. Epub 2004 Sep 9.
PubMed 15365608
Singh B, Zhang S, Ching CK, Huang D, Liu YB, Rodriguez DA, Hussin A, Kim YH, Chasnoits AR, Cerkvenik J, Muckala KA, Cheng A. Improving the utilization of implantable cardioverter defibrillators for sudden cardiac arrest prevention (Improve SCA) in developing countries: Clinical characteristics and reasons for implantation refusal. Pacing Clin Electrophysiol. 2018 Dec;41(12):1619-1626. doi: 10.1111/pace.13526. Epub 2018 Oct 31.
PubMed 30320410
Xu F, Zhang Y, Chen Y. Cardiopulmonary Resuscitation Training in China: Current Situation and Future Development. JAMA Cardiol. 2017 May 1;2(5):469-470. doi: 10.1001/jamacardio.2017.0035. No abstract available.
PubMed 28297007
Ringh M, Rosenqvist M, Hollenberg J, Jonsson M, Fredman D, Nordberg P, Jarnbert-Pettersson H, Hasselqvist-Ax I, Riva G, Svensson L. Mobile-phone dispatch of laypersons for CPR in out-of-hospital cardiac arrest. N Engl J Med. 2015 Jun 11;372(24):2316-25. doi: 10.1056/NEJMoa1406038.
PubMed 26061836
Kleinman ME, Brennan EE, Goldberger ZD, Swor RA, Terry M, Bobrow BJ, Gazmuri RJ, Travers AH, Rea T. Part 5: Adult Basic Life Support and Cardiopulmonary Resuscitation Quality: 2015 American Heart Association Guidelines Update for Cardiopulmonary Resuscitation and Emergency Cardiovascular Care. Circulation. 2015 Nov 3;132(18 Suppl 2):S414-35. doi: 10.1161/CIR.0000000000000259. No abstract available.
PubMed 26472993
Brooks SC, Anderson ML, Bruder E, Daya MR, Gaffney A, Otto CW, Singer AJ, Thiagarajan RR, Travers AH. Part 6: Alternative Techniques and Ancillary Devices for Cardiopulmonary Resuscitation: 2015 American Heart Association Guidelines Update for Cardiopulmonary Resuscitation and Emergency Cardiovascular Care. Circulation. 2015 Nov 3;132(18 Suppl 2):S436-43. doi: 10.1161/CIR.0000000000000260. No abstract available.
PubMed 26472994
Aufderheide TP, Pirrallo RG, Yannopoulos D, Klein JP, von Briesen C, Sparks CW, Deja KA, Kitscha DJ, Provo TA, Lurie KG. Incomplete chest wall decompression: a clinical evaluation of CPR performance by trained laypersons and an assessment of alternative manual chest compression-decompression techniques. Resuscitation. 2006 Dec;71(3):341-51. doi: 10.1016/j.resuscitation.2006.03.021. Epub 2006 Oct 27.
PubMed 17070644
Zhu N, Chen Q, Jiang Z, Liao F, Kou B, Tang H, Zhou M. A meta-analysis of the resuscitative effects of mechanical and manual chest compression in out-of-hospital cardiac arrest patients. Crit Care. 2019 Mar 27;23(1):100. doi: 10.1186/s13054-019-2389-6.
PubMed 30917840
Tang W, Weil MH, Noc M, Sun S, Gazmuri RJ, Bisera J. Augmented efficacy of external CPR by intermittent occlusion of the ascending aorta. Circulation. 1993 Oct;88(4 Pt 1):1916-21. doi: 10.1161/01.cir.88.4.1916.
PubMed 8403337
Gedeborg R, Silander HC, Rubertsson S, Wiklund L. Cerebral ischaemia in experimental cardiopulmonary resuscitation--comparison of epinephrine and aortic occlusion. Resuscitation. 2001 Sep;50(3):319-29. doi: 10.1016/s0300-9572(01)00350-1.
PubMed 11719162

Want to know more?

Mao Zhang, PHD

86-571-87784654

z2jzk@zju.edu.cn

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 8 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Research on Key Technologies and System Optimization of Early Warning and Resuscitation of Cardiac Arrest
ClinicalTrials.gov ID: NCT04955288
Acronym / sponsor ID: 2021-0420
Conditions: Emergencies
Keywords: 5G, Aortic Balloon Occlusion Catheter, Esophageal cooling device, Cardiopulmonary resuscitation
Study type: Interventional
Recruitment status: Unknown status
Enrolment: 1,000 participants (estimated)
Lead sponsor: Second Affiliated Hospital, Zhejiang University, School of MedicineUniversity, hospital or other
Study start: 1 Jan 2021 (actual)
Primary completion: 30 Dec 2023 (estimated)
Study completion: 30 Nov 2024 (estimated)
First posted: 8 Jul 2021 (actual)
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.

Detailed description

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.
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.
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.

Study design

Primary purpose: Other
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 4

Arm	Type	Receives
Aortic balloon Assisted resuscitation group	Experimental	Procedure: Aortic balloon assisted resuscitationThe 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.
Traditional cardiopulmonary resuscitation group	Active comparator	Procedure: Traditional cardiopulmonary resuscitationThe 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.
Esophageal cooling group	Experimental	Procedure: Esophageal coolingThe 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.
Traditional cooling group	Active comparator	Procedure: traditional coolingThe 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.

Who may qualify

Ages: 18 to 75 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (1 listed)

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

Key exclusion criteria (1 listed)

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

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
Aortic balloon assisted resuscitationOn 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.	Procedure or surgery	Aortic balloon Assisted resuscitation group
Traditional cardiopulmonary resuscitationUse 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.	Procedure or surgery	Traditional cardiopulmonary resuscitation group
Esophageal coolingThe 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.	Procedure or surgery	Esophageal cooling group
traditional coolingThe 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.	Procedure or surgery	Traditional cooling group

Primary outcome

return of spontaneous circulation (ROSC)
Time frame: 1-3 hours
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).

Results and safety

Results are not available in the source record.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 8 Jul 2021.
Background: PubMed 30700139Benjamin EJ, Muntner P, Alonso A, Bittencourt MS, Callaway CW, Carson AP, Chamberlain AM, Chang AR, Cheng S, Das SR, Delling FN, Djousse L, Elkind MSV, Ferguson JF, Fornage M, Jordan LC, Khan SS, Kissela BM, Knutson KL, Kwan TW, Lackland DT, Lewis TT, Lichtman JH, Longenecker CT, Loop MS, Lutsey PL, Martin SS, Matsushita K, Moran AE, Mussolino ME, O'Flaherty M, Pandey A, Perak AM, Rosamond WD, Roth GA, Sampson UKA, Satou GM, Schroeder EB, Shah SH, Spartano NL, Stokes A, Tirschwell DL, Tsao CW, Turakhia MP, VanWagner LB, Wilkins JT, Wong SS, Virani SS; American Heart Association Council on Epidemiology and Prevention Statistics Committee and Stroke Statistics Subcommittee. Heart Disease and Stroke Statistics-2019 Update: A Report From the American Heart Association. Circulation. 2019 Mar 5;139(10):e56-e528. doi: 10.1161/CIR.0000000000000659. No abstract available.
Background: PubMed 27865775Hawkes C, Booth S, Ji C, Brace-McDonnell SJ, Whittington A, Mapstone J, Cooke MW, Deakin CD, Gale CP, Fothergill R, Nolan JP, Rees N, Soar J, Siriwardena AN, Brown TP, Perkins GD; OHCAO collaborators. Epidemiology and outcomes from out-of-hospital cardiac arrests in England. Resuscitation. 2017 Jan;110:133-140. doi: 10.1016/j.resuscitation.2016.10.030. Epub 2016 Nov 17.
Background: PubMed 25151546Shao F, Li CS, Liang LR, Li D, Ma SK. Outcome of out-of-hospital cardiac arrests in Beijing, China. Resuscitation. 2014 Nov;85(11):1411-7. doi: 10.1016/j.resuscitation.2014.08.008. Epub 2014 Aug 20.
Background: PubMed 12479769Weisfeldt ML, Becker LB. Resuscitation after cardiac arrest: a 3-phase time-sensitive model. JAMA. 2002 Dec 18;288(23):3035-8. doi: 10.1001/jama.288.23.3035. No abstract available.
Background: PubMed 10966665Guidelines 2000 for Cardiopulmonary Resuscitation and Emergency Cardiovascular Care. Part 6: advanced cardiovascular life support: section 1: Introduction to ACLS 2000: overview of recommended changes in ACLS from the guidelines 2000 conference. The American Heart Association in collaboration with the International Liaison Committee on Resuscitation. Circulation. 2000 Aug 22;102(8 Suppl):I86-9. doi: 10.1161/01.cir.102.suppl_1.i-86. No abstract available.
Background: PubMed 15365608Laver S, Farrow C, Turner D, Nolan J. Mode of death after admission to an intensive care unit following cardiac arrest. Intensive Care Med. 2004 Nov;30(11):2126-8. doi: 10.1007/s00134-004-2425-z. Epub 2004 Sep 9.
Background: PubMed 30320410Singh B, Zhang S, Ching CK, Huang D, Liu YB, Rodriguez DA, Hussin A, Kim YH, Chasnoits AR, Cerkvenik J, Muckala KA, Cheng A. Improving the utilization of implantable cardioverter defibrillators for sudden cardiac arrest prevention (Improve SCA) in developing countries: Clinical characteristics and reasons for implantation refusal. Pacing Clin Electrophysiol. 2018 Dec;41(12):1619-1626. doi: 10.1111/pace.13526. Epub 2018 Oct 31.
Background: PubMed 28297007Xu F, Zhang Y, Chen Y. Cardiopulmonary Resuscitation Training in China: Current Situation and Future Development. JAMA Cardiol. 2017 May 1;2(5):469-470. doi: 10.1001/jamacardio.2017.0035. No abstract available.
Background: PubMed 26061836Ringh M, Rosenqvist M, Hollenberg J, Jonsson M, Fredman D, Nordberg P, Jarnbert-Pettersson H, Hasselqvist-Ax I, Riva G, Svensson L. Mobile-phone dispatch of laypersons for CPR in out-of-hospital cardiac arrest. N Engl J Med. 2015 Jun 11;372(24):2316-25. doi: 10.1056/NEJMoa1406038.
Background: PubMed 26472993Kleinman ME, Brennan EE, Goldberger ZD, Swor RA, Terry M, Bobrow BJ, Gazmuri RJ, Travers AH, Rea T. Part 5: Adult Basic Life Support and Cardiopulmonary Resuscitation Quality: 2015 American Heart Association Guidelines Update for Cardiopulmonary Resuscitation and Emergency Cardiovascular Care. Circulation. 2015 Nov 3;132(18 Suppl 2):S414-35. doi: 10.1161/CIR.0000000000000259. No abstract available.
Background: PubMed 26472994Brooks SC, Anderson ML, Bruder E, Daya MR, Gaffney A, Otto CW, Singer AJ, Thiagarajan RR, Travers AH. Part 6: Alternative Techniques and Ancillary Devices for Cardiopulmonary Resuscitation: 2015 American Heart Association Guidelines Update for Cardiopulmonary Resuscitation and Emergency Cardiovascular Care. Circulation. 2015 Nov 3;132(18 Suppl 2):S436-43. doi: 10.1161/CIR.0000000000000260. No abstract available.
Background: PubMed 17070644Aufderheide TP, Pirrallo RG, Yannopoulos D, Klein JP, von Briesen C, Sparks CW, Deja KA, Kitscha DJ, Provo TA, Lurie KG. Incomplete chest wall decompression: a clinical evaluation of CPR performance by trained laypersons and an assessment of alternative manual chest compression-decompression techniques. Resuscitation. 2006 Dec;71(3):341-51. doi: 10.1016/j.resuscitation.2006.03.021. Epub 2006 Oct 27.
Individual participant dataSharing planned: No

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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. This study is not recruiting at the moment.

Mao Zhang, PHD contact

86-571-87784654

z2jzk@zju.edu.cn

Mao Zhang, PHD study chair

Second Affiliated Hospital of Zhejiang University School of Medicine

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 1 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: status not confirmed, as of the sponsor's last update on 8 Jul 2021. 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 China. 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?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Mao Zhang, PHD (86-571-87784654, z2jzk@zju.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

return of spontaneous circulation (ROSC) (time frame: 1-3 hours). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04955288, which also lists 29 linked publications.

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 8 Jul 2021.