Clinical trial NCT06447805: Early Double Sequential Defibrillation in Out-of-hospital Cardiac Arrest
Official title: "A Pilot Study Assessing Feasibility of a Randomized Trial Comparing the Effect of Early Double Sequential Defibrillation as Soon as Possible in OHCA With a Shockable Rhythm (VT/VF) Compared to Standard Defibrillation"
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Cardiac Arrest
Fibrillation, Ventricular
Sudden Cardiac Death
Sudden Cardiac Arrest
Keywords: Cardiopulmonary resuscitation
Defibrillation
Double sequential defibrillation
Lead sponsor: Karolinska Institutet
Sponsor class: OTHER
First posted: 2024-06-07
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Academic, investigator initiated, open-label pilot study with a randomized controlled trial (RCT) design and 3:1 allocation (3 intervention: 1 standard).
Primary purpose: TREATMENT

Brief summary: 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).

To evaluate feasibility and safety this randomized pilot trial will compare the effect of double defibrillation strategy initiated as soon as possible after the first defibrillation with continued resuscitation using standard defibrillation, in patients with Out of Hospital Cardiac arrest (OHCA). The results from this pilot trial will form the basis for design of a larger multicenter survival study.

Detailed description: The Dubbel-D study is an academic, investigator initiated, open-label pilot study with a randomized controlled trial (RCT) design conducted in the prehospital emergency medical services, i.e. ambulance organizations. The trial will be conducted by participating ambulance units attending OHCA´s. These units will perform screening for inclusion, randomization, intervention or control treatment and initial follow-up.

In all cases of OHCA a defibrillator should always be attached with the standard pad placement, anterio-lateral (A-L) position first. This is in accordance with standard of care. If there is VT/VF or an automated external defibrillator (AED) suggests defibrillation, defibrillation should be performed, and immediate chest compressions resumed. Thereafter, the patient can be screened for inclusion. If two study specific defibrillators (Corpulse 3) on site and no exclusion criteria (age below 18 years, obvious pregnancy, known preexisting Do Not Attempt Resuscitation order) the patient can be included and randomized.

Randomization will be performed by drawing a scratch-card with concealed allocation that will be stored with the EMS defibrillators. All scratch-cards will be pre-randomized in a 3:1 ratio in blocks consisting of 4-8-12 and stratified by region and ambulance provider.

If the patient is randomized to the intervention group, the ambulance crew team will apply the second defibrillator with electrodes placed in the anterio-posterior (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.

If randomized to the control group, the ambulance crew team will continue Advanced Life Support (ACLS) in accordance with standard of care. Defibrillation is performed with standard electrode placement (A-L position) using a single defibrillator. If an AED is the first defibrillator attached to the patient, the ambulance crew should shift from an AED to their own manual defibrillator, but the mode of defibrillation should remain in A-L position and only one defibrillator should be used for each defibrillation and continue until ROSC, termination of resuscitation or decision to move the patient to hospital.

Eligibility criteria: Inclusion Criteria:

* Out-of-Hospital patients with Ventricular Fibrillation/ Ventricular Tachycardia at rhythm analysis after ambulance arrival and at least one defibrillation performed in standard (Antero-Lateral) position

Exclusion Criteria:

* Age below 18 years
* Obvious pregnancy
* Known preexisting Do Not Attempt Resuscitation order

Primary outcomes:
measure: Feasibility of early double sequential external defibrillation (DSD)
timeFrame: day 1
measure: Adherence to double sequential external defibrillation (DSD)
timeFrame: day 1
measure: Cross-over
timeFrame: day 1
measure: Feasibility of double sequential external defibrillation (DSD)
timeFrame: day 1
measure: Safety of double sequential external defibrillation
timeFrame: day 1
measure: Safety of CPR during double sequential external defibrillation
timeFrame: day 1
Secondary outcomes:
measure: Return of spontaneous circulation (ROSC)
timeFrame: day 1
measure: Number of defibrillations to sustained ROSC
timeFrame: day 1
measure: Survival to hospital admission
timeFrame: day 1
measure: Survival to discharge
timeFrame: day 1-180
measure: 30 day survival
timeFrame: day 30
measure: Neurological function at 30 days
timeFrame: day 30
measure: Neurological function and Health related Quality of life at 90 and 180 days
timeFrame: day 90 and 180
Other outcomes:
Locations:
city: Halmstad
country: Sweden
facility: Emergency medical services Region Halland
state: Halland
city: Göteborg
country: Sweden
facility: Sahlgrenska Universitetssjukhuset, Ambulans och Prehospital Akutsjukvård
state: Västra Götalandsregionen
city: Alingsås
country: Sweden
facility: Sjukhusen i väster, ambulanssjukvården Alingsås/Lerum
state: Västra Götalandsregionen
Study officials:
affiliation: Karolinska Institutet
name: Gabriel Riva, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Karolinska Institutet
name: Akil Awad, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Karolinska Institutet
name: Andreas Claesson, RN, PhD
role: STUDY_CHAIR
affiliation: Sahlgrenska University
name: Carl Magnusson, RN, PhD
role: STUDY_CHAIR
affiliation: Karolinska Institutet
name: Leif Svensson, MD, PhD
role: STUDY_CHAIR
affiliation: Linné University
name: Johan Israelsson, RN, PhD
role: STUDY_CHAIR
affiliation: Karolinska Institutet
name: Emma Blick-Nordqvist, MD
role: STUDY_CHAIR
affiliation: Karolinska Institutet
name: Martin Jonsson, Msc, PhD
role: STUDY_CHAIR
affiliation: Karolinska Institutet
name: Jacob Hollenberg, MD, PhD
role: STUDY_CHAIR
affiliation: University of Toronto
name: Sheldon Cheskes, MD
role: STUDY_CHAIR
References:
citation: Cheskes S, Verbeek PR, Drennan IR, McLeod SL, Turner L, Pinto R, Feldman M, Davis M, Vaillancourt C, Morrison LJ, Dorian P, Scales DC. Defibrillation Strategies for Refractory Ventricular Fibrillation. N Engl J Med. 2022 Nov 24;387(21):1947-1956. doi: 10.1056/NEJMoa2207304. Epub 2022 Nov 6.