Ignite Creation Date:
2024-06-16 @ 11:51 AM
Last Modification Date:
2024-10-26 @ 3:31 PM
Study NCT ID:
NCT06447805
Status:
RECRUITING
Last Update Posted:
2024-07-12
First Post:
2024-05-29
Brief Title:
Early Double Sequential Defibrillation in Out-of-hospital Cardiac Arrest
Sponsor:
Karolinska Institutet
Organization:
Karolinska Institutet
Study Overview
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 VTVF Compared to Standard Defibrillation
Status:
RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
DOUBLE-D
Brief Summary:
Some of the patients affected by Out-of-hospital cardiac arrest OHCA with ventricular fibrillation VFventricular tachycardia VT do not respond to initial defibrillation The survival decreases with number of defibrillations required to terminate VFVT 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
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 ie ambulance organizations The trial will be conducted by participating ambulance units attending OHCAs 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 VTVF 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 31 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
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 VTVF 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 31 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None