Ignite Creation Date:
2024-05-05 @ 12:01 PM
Last Modification Date:
2024-10-26 @ 9:18 AM
Study NCT ID:
NCT00212992
Status:
COMPLETED
Last Update Posted:
2017-01-24
First Post:
2005-09-13
Brief Title:
Biphasic Defibrillation Study Trial to Compare Fixed Versus Escalating Energy
Sponsor:
Ottawa Hospital Research Institute
Organization:
Ottawa Hospital Research Institute
Study Overview
Official Title:
A Pilot Randomized Controlled Trial to Compare Fixed Versus Escalating Energy Regimens for Biphasic Waveform Defibrillation
Status:
COMPLETED
Status Verified Date:
2017-01
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:
None
Brief Summary:
This study will compare the effect of constant low-level energy 150 joules to an escalating energy 200-300-360 joules regimen of biphasic waveform defibrillation on multiple patient outcomes
Detailed Description:
This pilot which will enroll 200 subjects will allow a reasonable estimate of effect size and this will in turn allow for the accurate design and planning of a definitive randomized controlled trial The following outcomes will be evaluated
1 Important Clinical Outcomes
Successful conversion
Resuscitation to one hour
Survival to hospital discharge
Neurological function and
Quality of life
2 Process Outcomes
Number of shocks required
Recurrences of VF and
Responsiveness to varying periods of pulselessness
3 Adverse Outcomes
Myocardial damage
1 Important Clinical Outcomes
Successful conversion
Resuscitation to one hour
Survival to hospital discharge
Neurological function and
Quality of life
2 Process Outcomes
Number of shocks required
Recurrences of VF and
Responsiveness to varying periods of pulselessness
3 Adverse Outcomes
Myocardial damage
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?:
None
Is an FDA AA801 Violation?:
None