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

NCT04955288 | Unknown

• 1 other identifier: 2021-0420
• Study Type: interventional
• Target: 1,000
• Locations: 1 country
• Sites: 1

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.

Conditions

Emergencies

Keywords

5G; Aortic Balloon Occlusion Catheter; Esophageal cooling device; Cardiopulmonary resuscitation

Outcome Measures

Primary Outcomes (1)

• 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

Other Outcomes (5)

• survival to discharge

  2 days

• survival to discharge without severe neurological impairment

  2 days

• 1-month survival without severe neurological impairment

  1 months

Study Arms (4)

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.

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.

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.

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.

Procedure: traditional cooling

Interventions

Aortic balloon assisted resuscitation PROCEDURE

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.

Aortic balloon Assisted resuscitation group

Traditional cardiopulmonary resuscitation PROCEDURE

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.

Traditional cardiopulmonary resuscitation group

Esophageal cooling PROCEDURE

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.

Esophageal cooling group

traditional cooling PROCEDURE

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.

Traditional cooling group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Second Affiliated Hospital, School of Medicine, Zhejiang University: lead

Study Sites (1)

Second Affiliated Hospital, Zhejiang University School of Medicine & Institute of Emergency Medicine, Zhejiang University

Hangzhou, Zhejiang, 310009, China

RECRUITING

Related Publications (29)

• 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.

  PMID: 30700139 BACKGROUND

• 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.

  PMID: 27865775 BACKGROUND

• 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.

  PMID: 25151546 BACKGROUND

• 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.

  PMID: 12479769 BACKGROUND

• 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.

  PMID: 10966665 BACKGROUND

• 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.

  PMID: 15365608 BACKGROUND

• 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.

  PMID: 30320410 BACKGROUND

• 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.

  PMID: 28297007 BACKGROUND

• 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.

  PMID: 26061836 BACKGROUND

• 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.

  PMID: 26472993 BACKGROUND

• 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.

  PMID: 26472994 BACKGROUND

• 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.

  PMID: 17070644 BACKGROUND

• 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.

  PMID: 30917840 BACKGROUND

• 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.

  PMID: 8403337 BACKGROUND

• 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.

  PMID: 11719162 BACKGROUND

• Tsurukiri J, Akamine I, Sato T, Sakurai M, Okumura E, Moriya M, Yamanaka H, Ohta S. Resuscitative endovascular balloon occlusion of the aorta for uncontrolled haemorrahgic shock as an adjunct to haemostatic procedures in the acute care setting. Scand J Trauma Resusc Emerg Med. 2016 Feb 9;24:13. doi: 10.1186/s13049-016-0205-8.

  PMID: 26861070 BACKGROUND

• Chaudery M, Clark J, Morrison JJ, Wilson MH, Bew D, Darzi A. Can contrast-enhanced ultrasonography improve Zone III REBOA placement for prehospital care? J Trauma Acute Care Surg. 2016 Jan;80(1):89-94. doi: 10.1097/TA.0000000000000863.

  PMID: 26683394 BACKGROUND

• Daley J, Morrison JJ, Sather J, Hile L. The role of resuscitative endovascular balloon occlusion of the aorta (REBOA) as an adjunct to ACLS in non-traumatic cardiac arrest. Am J Emerg Med. 2017 May;35(5):731-736. doi: 10.1016/j.ajem.2017.01.010. Epub 2017 Jan 12.

  PMID: 28117180 BACKGROUND

• Brede JR, Lafrenz T, Klepstad P, Skjaerseth EA, Nordseth T, Sovik E, Kruger AJ. Feasibility of Pre-Hospital Resuscitative Endovascular Balloon Occlusion of the Aorta in Non-Traumatic Out-of-Hospital Cardiac Arrest. J Am Heart Assoc. 2019 Nov 19;8(22):e014394. doi: 10.1161/JAHA.119.014394. Epub 2019 Nov 11.

  PMID: 31707942 BACKGROUND

• Xu J, Shen P, Gao Y, Xia S, Liu S, Li Z, Zhou G, Xu Y, Zhang M. The Effects of the Duration of Aortic Balloon Occlusion on Outcomes of Traumatic Cardiac Arrest in a Porcine Model. Shock. 2019 Sep;52(3):e12-e21. doi: 10.1097/SHK.0000000000001235.

  PMID: 30052583 BACKGROUND

• Neumar RW, Nolan JP, Adrie C, Aibiki M, Berg RA, Bottiger BW, Callaway C, Clark RS, Geocadin RG, Jauch EC, Kern KB, Laurent I, Longstreth WT Jr, Merchant RM, Morley P, Morrison LJ, Nadkarni V, Peberdy MA, Rivers EP, Rodriguez-Nunez A, Sellke FW, Spaulding C, Sunde K, Vanden Hoek T. Post-cardiac arrest syndrome: epidemiology, pathophysiology, treatment, and prognostication. A consensus statement from the International Liaison Committee on Resuscitation (American Heart Association, Australian and New Zealand Council on Resuscitation, European Resuscitation Council, Heart and Stroke Foundation of Canada, InterAmerican Heart Foundation, Resuscitation Council of Asia, and the Resuscitation Council of Southern Africa); the American Heart Association Emergency Cardiovascular Care Committee; the Council on Cardiovascular Surgery and Anesthesia; the Council on Cardiopulmonary, Perioperative, and Critical Care; the Council on Clinical Cardiology; and the Stroke Council. Circulation. 2008 Dec 2;118(23):2452-83. doi: 10.1161/CIRCULATIONAHA.108.190652. Epub 2008 Oct 23. No abstract available.

  PMID: 18948368 BACKGROUND

• Nolan JP, Soar J, Cariou A, Cronberg T, Moulaert VR, Deakin CD, Bottiger BW, Friberg H, Sunde K, Sandroni C. European Resuscitation Council and European Society of Intensive Care Medicine Guidelines for Post-resuscitation Care 2015: Section 5 of the European Resuscitation Council Guidelines for Resuscitation 2015. Resuscitation. 2015 Oct;95:202-22. doi: 10.1016/j.resuscitation.2015.07.018. No abstract available.

  PMID: 26477702 BACKGROUND

• Lascarrou JB, Merdji H, Le Gouge A, Colin G, Grillet G, Girardie P, Coupez E, Dequin PF, Cariou A, Boulain T, Brule N, Frat JP, Asfar P, Pichon N, Landais M, Plantefeve G, Quenot JP, Chakarian JC, Sirodot M, Legriel S, Letheulle J, Thevenin D, Desachy A, Delahaye A, Botoc V, Vimeux S, Martino F, Giraudeau B, Reignier J; CRICS-TRIGGERSEP Group. Targeted Temperature Management for Cardiac Arrest with Nonshockable Rhythm. N Engl J Med. 2019 Dec 12;381(24):2327-2337. doi: 10.1056/NEJMoa1906661. Epub 2019 Oct 2.

  PMID: 31577396 BACKGROUND

• Schock RB, Janata A, Peacock WF, Deal NS, Kalra S, Sterz F. Time to Cooling Is Associated with Resuscitation Outcomes. Ther Hypothermia Temp Manag. 2016 Dec;6(4):208-217. doi: 10.1089/ther.2016.0026. Epub 2016 Oct 19.

  PMID: 27906641 BACKGROUND

• Chenoune M, Lidouren F, Adam C, Pons S, Darbera L, Bruneval P, Ghaleh B, Zini R, Dubois-Rande JL, Carli P, Vivien B, Ricard JD, Berdeaux A, Tissier R. Ultrafast and whole-body cooling with total liquid ventilation induces favorable neurological and cardiac outcomes after cardiac arrest in rabbits. Circulation. 2011 Aug 23;124(8):901-11, 1-7. doi: 10.1161/CIRCULATIONAHA.111.039388. Epub 2011 Aug 1.

  PMID: 21810660 BACKGROUND

• Deye N, Cariou A, Girardie P, Pichon N, Megarbane B, Midez P, Tonnelier JM, Boulain T, Outin H, Delahaye A, Cravoisy A, Mercat A, Blanc P, Santre C, Quintard H, Brivet F, Charpentier J, Garrigue D, Francois B, Quenot JP, Vincent F, Gueugniaud PY, Mira JP, Carli P, Vicaut E, Baud FJ; Clinical and Economical Impact of Endovascular Cooling in the Management of Cardiac Arrest (ICEREA) Study Group. Endovascular Versus External Targeted Temperature Management for Patients With Out-of-Hospital Cardiac Arrest: A Randomized, Controlled Study. Circulation. 2015 Jul 21;132(3):182-93. doi: 10.1161/CIRCULATIONAHA.114.012805. Epub 2015 Jun 19.

  PMID: 26092673 BACKGROUND

• Polderman KH, Noc M, Beishuizen A, Biermann H, Girbes AR, Tully GW, Seidman D, Albertsson PA, Holmberg M, Sterz F, Holzer M. Ultrarapid Induction of Hypothermia Using Continuous Automated Peritoneal Lavage With Ice-Cold Fluids: Final Results of the Cooling for Cardiac Arrest or Acute ST-Elevation Myocardial Infarction Trial. Crit Care Med. 2015 Oct;43(10):2191-201. doi: 10.1097/CCM.0000000000001158.

  PMID: 26196354 BACKGROUND

• Xu J, Jin X, Chen Q, Wu C, Li Z, Zhou G, Xu Y, Qian A, Li Y, Zhang M. Faster Hypothermia Induced by Esophageal Cooling Improves Early Markers of Cardiac and Neurological Injury After Cardiac Arrest in Swine. J Am Heart Assoc. 2018 Nov 6;7(21):e010283. doi: 10.1161/JAHA.118.010283.

  PMID: 30608213 BACKGROUND

• Xu J, Chen Q, Jin X, Wu C, Li Z, Zhou G, Xu Y, Qian A, Li Y, Zhang M. Early Initiation of Continuous Renal Replacement Therapy Induces Fast Hypothermia and Improves Post-Cardiac Arrest Syndrome in a Porcine Model. Shock. 2019 Oct;52(4):456-467. doi: 10.1097/SHK.0000000000001276.

  PMID: 30335673 BACKGROUND

MeSH Terms

Conditions

Emergencies

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Mao Zhang, PHD

  Second Affiliated Hospital of Zhejiang University School of Medicine

  STUDY CHAIR

Central Study Contacts

Mao Zhang, PHD

CONTACT

86-571-87784654; z2jzk@zju.edu.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 20, 2021
• First Posted: July 8, 2021
• Study Start: January 1, 2021
• Primary Completion: December 30, 2023
• Study Completion: November 30, 2024
• Last Updated: July 8, 2021

Record last verified: 2021-06

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)