FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2026/01/102381 [Registered on: 28/01/2026] Trial Registered Prospectively
Last Modified On: 28/01/2026
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Process of Care Changes 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   A Study Comparing Two Methods of Defibrillation Used During Cardiac Arrest 
Scientific Title of Study   Comparison of Conventional Defibrillation (CDF) with Double Sequential External Defibrillation (DSDF) in achieving Return Of Spontaneous Circulation (ROSC) in Refractory Ventricular Fibrillation(VF) and pulseless Ventricular Tachycardia (pVT) 
Trial Acronym  nil 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Gunjan Chanchalani 
Designation  Director Critical Care Medicine 
Affiliation  Wockhardt Hospitals LTD 
Address  Wockhardt Hospitals LTD Adams Wylie Memorial 1877 Dr Anand Rao Nair Road Mumbai Central

Mumbai
MAHARASHTRA
400011
India 
Phone  9757169559  
Fax    
Email  Gunjan.Chanchalani@wockhardthospitals.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Gunjan Chanchalani 
Designation  Director Critical Care Medicine 
Affiliation  Wockhardt Hospitals LTD 
Address  Wockhardt Hospitals LTD Adams Wylie Memorial 1877 Dr Anand Rao Nair Road Mumbai Central

Mumbai
MAHARASHTRA
400011
India 
Phone  9757169559  
Fax    
Email  Gunjan.Chanchalani@wockhardthospitals.com  
 
Details of Contact Person
Public Query
 
Name  Dr Gunjan Chanchalani 
Designation  Director Critical Care Medicine 
Affiliation  Wockhardt Hospitals LTD 
Address  Wockhardt Hospitals LTD Adams Wylie Memorial 1877 Dr Anand Rao Nair Road Mumbai Central

Mumbai
MAHARASHTRA
400011
India 
Phone  9757169559  
Fax    
Email  Gunjan.Chanchalani@wockhardthospitals.com  
 
Source of Monetary or Material Support  
Indian Society of Critical Care Medicine 
 
Primary Sponsor  
Name  Indian Society of Critical Care Medicine 
Address  Unit 13 and 14, first floor Hind Service Industrial Premises Co operative Society Near Chaitya Bhoomi Dadar, Mumbai 400028 
Type of Sponsor  Other [Non profit organisation] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Gunjan Chanchalani  Wockhardt Hospitals LTD  10th Floor,ICU Police Station, 1877, Dr Anandrao Nair Marg, near Agripada, Mumbai Central, Mumbai, Maharashtra 400011
Mumbai
MAHARASHTRA 
9757169559

Gunjan.Chanchalani@wockhardthospitals.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Wockhardt Hospitals Institutional Review Board  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: O||Medical and Surgical, (2) ICD-10 Condition: I229||Subsequent ST elevation (STEMI) myocardial infarction of unspecified site, (3) ICD-10 Condition: J960||Acute respiratory failure, (4) ICD-10 Condition: S00-T88||Injury, poisoning and certain other consequences of external causes, (5) ICD-10 Condition: R00-R99||Symptoms, signs and abnormal clinical and laboratory findings, not elsewhere classified, (6) ICD-10 Condition: Z00-Z99||Factors influencing health status and contact with health services,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Conventional Singal Defibrillation  Conventional single defibrillation using standard defibrillation pad placement and energy levels as per current Advanced Cardiac Life Support (ACLS) guidelines in patients with refractory ventricular fibrillation or pulseless ventricular tachycardia.  
Intervention  Double Sequential Defibrillation   Double sequential defibrillation (DSDF) using two defibrillators delivering sequential shocks for refractory ventricular fibrillation or pulseless ventricular tachycardia after three standard defibrillation attempts.  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  99.00 Year(s)
Gender  Both 
Details  All adult patients with refractory VF and pVT as defined by VF / pVT persisting after
administration of three consecutive shocks delivered as per current ACLS recommendations 
 
ExclusionCriteria 
Details  Patients with AICD
Spine Trauma
Traumatic Cardiac arrest
Pregnancy
DNR status 
 
Method of Generating Random Sequence   Permuted block randomization, fixed 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Primary Outcome: To compare achievement of ROSC between CDF and DSDF in refractory VF/pVT
 
During Resuscitation and at Hospital discharge 
 
Secondary Outcome  
Outcome  TimePoints 
Secondary Outcome: Survival to hospital discharge

Absence of VF / pVT on subsequent rhythm analysis after defibrillation and a 2-minute
interval of CPR
VF / pVT recurrence within 24 hrs
a good neurologic outcome at hospital discharge, defined as modified Rankin scale score
of 2 or lower 
Survival to hospital discharge 
 
Target Sample Size   Total Sample Size="246"
Sample Size from India="246" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   N/A 
Date of First Enrollment (India)   24/02/2026 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="2"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary  

Comparison of Conventional Defibrillation (CDF) with Double Sequential External Defibrillation (DSDF) in achieving Return Of Spontaneous Circulation (ROSC) in Refractory Ventricular Fibrillation(VF) and pulseless Ventricular Tachycardia (pVT)

 

Background:

Factors affecting defibrillation success is proportional to the transthoracic impedance, which decreases with recurrent shock, apart from more success with higher energies and vector change. Double Sequential External Defibrillation (DSDF) is delivery of two defibrillating currents from two separate defibrillator devices, to be administered one after another as close as possible, with a small deliberate pause. The first current lowers the defibrillation threshold of the myocardium and increases the success rate of the subsequent transthoracic current. Also, the number of vectors via which the current reaches the myocardium increases as well as the energy delivered, and thus the defibrillation success.

Review of Literature:

Lower energies for successful defibrillation with the use of sequential pulse defibrillation with the use of epicardial electrodes, were demonstrated in volunteer patients of WPW syndrome undergoing accessory pathway ablation.(1) However, a systematic review for use of DSDF for refractor ventricular fibrillation cardiac arrest failed to show improved outcomes in OHCA.(2) Recently published Dose-VF trial found a higher rates of VF termination (66.6% in CDF and 76.3% in DSDF) and ROSC (25% vs 40%) with the use of DSDF in OHCA patients.(3)

Aim: To compare the efficacy of CDF with DSDF in achieving ROSC among patients with refractory VF and pulseless Ventricular Tachycardia (pVT)

Study Design: Prospective, open label, multi Centre RCT in India

Inclusion Criteria: All adult patients with refractory VF and pVT as defined by VF / pVT persisting after administration of three consecutive shocks delivered as per current ACLS recommendations

Exclusion Criteria: Patients with AICD

                            Spine Trauma

                           Traumatic Cardiac arrest

                           Pregnancy

                           DNR status

Study method-

Cohort: Patients presenting with either Out of Hospital Cardiac Arrest (OHCA) or having In Hospital Cardiac Arrest (IHCA) – with refractory VF and pVT

Cohort 1: IHCA – Two arms CDF and DSDF

Cohort 2 OHCA – Two arms CDF and DSDF

Randomization: Block randomization – treatment sequence will be generated for each centre participating prior to the start of the study.

All included patients will be given initial resuscitation as per the current AHA guidelines – which includes high quality CPR and defibrillation via antero-lateral pad placement and administration of emergency drugs, with or without use of advanced airway.

After the third failed attempt at defibrillation, the patient will be allocated to either the control group or intervention group.

Control group: CDF – All subsequent defibrillation attempts will continue with the same placement of pads.

Intervention group: DSDF – A second set of defibrillation pads will be applied in antero-posterior position with minimal interruption in CPR. All subsequent defibrillation will be done by sequential shocks delivered with a short interval (less than 1 second) between the two shocks – by a single operator pressing the shock button in rapid succession

Outcome measures:

Primary Outcome: To compare achievement of ROSC between CDF and DSDF in refractory VF/pVT

Secondary Outcome: Survival to hospital discharge

                        Absence of VF / pVT on subsequent rhythm analysis after defibrillation and a 2-minute interval of CPR

                         VF / pVT recurrence within 24 hrs

                        a good neurologic outcome at hospital discharge, defined as modified Rankin scale score of 2 or lower


References:

1-     Jones DL, Klein GJ, Guiraudon GM, Sharma AD. Sequential pulse defibrillation in humans: orthogonal sequential pulse defibrillation with epicardial electrodes. J Am Coll Cardiol. 1988;11(3):590–596. doi: 10.1016/0735-1097(88)91536-7.

2-     Deakin CD, Morley P, Soar J, Drennan IR. Double sequential defibrillation for refractory ventricular fibrillation cardiac arrest: a systematic review. Resuscitation. 2020;155:24–31

3-     Cheskes S, Dorian P, Feldman M, McLeod S, Scales DC, Pinto R, Turner L, Morrison LJ, Drennan IR, Verbeek PR. Double sequential external defibrillation for refractory ventricular fibrillation: The DOSE VF pilot randomized controlled trial. Resuscitation. 2020 May;150:178-184. doi: 10.1016/j.resuscitation.2020.02.010. Epub 2020 Feb 19. PMID: 32084567.

 
Close