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临床试验/NCT07174986
NCT07174986招募中2 期

"A Randomized Trial Assessing the Effect of Early Double Sequential Defibrillation With Anterior-posterior and Anterior Lateral Pad Placement and Sequential Defibrillation Compared to Standard Pad Placement and Single Defibrillation in Patients With Out of Hospital Cardiac Arrest With Initial Shockable Rhythm and at Least One Failed Standard Defibrillation"

Gabriel Riva15 个研究点 分布在 3 个国家目标入组 916 人开始时间: 2025年9月8日最近更新:
适应症
干预措施

试验速览

阶段
2 期
状态
招募中
发起方
入组人数
916
试验地点
15
主要终点
30 day survival

研究概览

简要总结

Some of the patients affected by Out-of-hospital cardiac arrest (OHCA) with ventricular fibrillation (VF)/ventricular tachycardia (VT) do not respond to initial defibrillation. The survival decreases with number of defibrillations required to terminate VF/VT. In 2022, one prospective cluster randomized trial showed increased survival among (OHCA) patients in refractory VF using Double Sequential Defibrillation (DSD). If DSD can increase survival among all patients in VF that dont respond to one defibrillation, i.e. before it has become refractory is not known.

The aim of this trial is to assess survival with a double defibrillation strategy initiated as soon as possible among patients with Out of Hospital Cardiac Arrest with initial shockable rhythm and at least one failed standard defibrillation, compared with continued resuscitation using standard defibrillation.

详细描述

Background: Out-of-hospital cardiac arrest (OHCA) affects about 270,000 individuals in Europe annually.[1] In OHCA, presenting with ventricular fibrillation (VF) or pulseless ventricular tachycardia (VT) amendable to defibrillation are among the strongest predictors of survival.[2] If defibrillation can be done successfully within the first 3-5 minutes survival can be as high as 70 %.[3] However, some patients in VT/VF do not respond to initial defibrillation, and survival decreases with number of defibrillations required to terminate VT/VF.[4]

In 2022, one prospective cluster randomized trial showed increased survival among OHCA patients in refractory VF using an alternative defibrillation strategy with either, switching to Anterior-Posterior defibrillation pad placements (A-P) or Double Sequential Defibrillation "DSD", (Using two defibrillators, one in the standard anterior-lateral position (A-L) and one in A-P position and defibrillation in rapid sequence) compared to standard defibrillation pad placement.[5] Refractory VF was defined as VF that persisted despite three consecutive defibrillations with defibrillation pads in the standard position.

These results prompted the International Liaison Committee on Resuscitation (ILCOR) to release a statement of treatment recommendation on DSD in March 6, 2023. It suggested that "…either vector change or DSD may be considered for adults with cardiac arrest who remain in VF or pulseless VT despite three defibrillations (weak recommendation, low certainty of evidence)." [6] Further, if DSD would be used it should be performed with a methodology similar to that described in the trial by Cheskes et al.

However, several questions remain. Knowledge gaps highlighted in the ILCOR statement included if the results from this one cluster randomized trial could be reproduced in any other setting. Further, since survival is inversely associated with the number of defibrillation shocks, if earlier application of DSD could lead to even higher survival for patients not in refractory VF has never been studied.

Study rationale: In order to evaluate if an early DSD-strategy could benefit all patients with VT/VF after the first shock, including those not in refractory VF, the Double-D trial is designed. If DSD would prove to be superior to standard defibrillation in a broader cardiac arrest population, also among those not in refractory VF, this would have a large impact on how Advanced Cardiac Life Support (ACLS) should be performed.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Double (Participant, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • OHCA patients with VT/VF at first rhythm analysis and at least one defibrillation performed in standard (A-L) position

排除标准

  • Age < 18 years
  • Obvious pregnancy
  • Known preexisting Do Not Attempt Resuscitation order

研究组 & 干预措施

Early Double sequential defibrillation

Experimental

If the patient is randomized to the DSD group, the ambulance crew team will apply the second defibrillator with electrodes placed in the A-P position as soon as possible.

Defibrillation is performed by one person defibrillating both defibrillators in a sequential manner "Double Sequential Defibrillation" (DSD). All consecutive defibrillations will thereafter be performed with the DSD strategy until ROSC, termination of resuscitation or decision to move the patient to hospital.

干预措施: Double sequential defibirllation (Device)

Standard defibrillation

Active Comparator

If the patient is randomized to the standard defibrillation group, the ambulance crew team will continue Advanced life support in accordance with standard of care and continue to perform standard defibibrillation using one defibrillator. All consecutive defibrillations will thereafter be performed with the standard defibrillation strategy until ROSC, termination of resuscitation or decision to move the patient to hospital.

干预措施: Standard defibrillation (Device)

结局指标

主要结局

30 day survival

时间窗: 30 days

Survival at 30 days

次要结局

  • Neurological function at hospital discharge, mRS (modified Ranking scale, 1-6 where 1 indicates better function)(30 days)
  • Survival to hospital discharge(30 days)
  • Survival to hospital Admission(1 day)
  • ROSC(1 day)

研究者

发起方
Gabriel Riva
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Gabriel Riva

Principal Investigator

Karolinska Institutet

研究点 (15)

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