Early Double Sequential Defibrillation in Out-of-hospital Cardiac Arrest

Cardiac Arrest Clinical Trial

— DOUBLE-D  

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"

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06447805
• Other study ID #: CIV-ID-24-01-045759
• Status: Not yet recruiting
• Phase: N/A
• Start date: June 10, 2024
• Est. completion date: June 1, 2026

Study information

• Verified date: June 2024
• Source: Karolinska Institutet
• Contact: Gabriel Riva, MD, PhD
• Phone: 0046705452086
• Email: gabriel.riva[@]ki.se
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 40
• Est. completion date: June 1, 2026
• Est. primary completion date: December 31, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cardiac Arrest
• Death
• Death, Sudden, Cardiac
• Fibrillation, Ventricular
• Heart Arrest
• Sudden Cardiac Arrest
• Sudden Cardiac Death
• Ventricular Fibrillation

Intervention

Device:
• Double Sequential Defibrillation (DSD)
The second defibrillator will be applyed with electrodes placed in the A-P position
• Standard defibrillation
Standard defibrillation uning one defibrillator

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Karolinska Institutet

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Feasibility of early double sequential external defibrillation (DSD)	Number of EMS defibrillations prior to randomization (target > 80% before third defibrillation)	day 1
Primary	Adherence to double sequential external defibrillation (DSD)	Among patients randomized to DSD, proportion that received DSD (target > 80%)	day 1
Primary	Cross-over	Among patients randomized to standard, proportion that received DSD (target < 10%)	day 1
Primary	Feasibility of double sequential external defibrillation (DSD)	Proportion of eligible patients included and randomized (target > 80%)	day 1
Primary	Safety of double sequential external defibrillation	Major adverse events (e.g. defibrillator malfunction)	day 1
Primary	Safety of CPR during double sequential external defibrillation	Chest compression fraction (hands off time during CPR, target > 80% in both groups)	day 1
Secondary	Return of spontaneous circulation (ROSC)	Proportion of patients with sustained return of spontaneous circulation (ROSC) at hospital arrival	day 1
Secondary	Number of defibrillations to sustained ROSC	Total number of defibrillations to sustained ROSC	day 1
Secondary	Survival to hospital admission	Pateint is admitted to hospital alive	day 1
Secondary	Survival to discharge	Survival to hospital discharge	day 1-180
Secondary	30 day survival	Survival at 30 days	day 30
Secondary	Neurological function at 30 days	Neurological function (modified Rankin Scale, mRS 1-6, and Cerebral Performance Category, CPC 1-5) at 30 days	day 30
Secondary	Neurological function and Health related Quality of life at 90 and 180 days	Neurological function (modifiied Rankin Scale and Cerebral Performance Category) and Health-related Quality of life at 90 and 180 days (CPC 1-5, mRS 1-6)	day 90 and 180