VectOr ChAnge defibriLlatIon in Refractory Shockable rhyThms

NCT05926973 | Unknown

• 1 other identifier: TVAA02/23
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

Management of cardiac arrest according to published guidelines has remained largely unchanged for a decade. Thames Valley Air Ambulance provide Critical Care Paramedic and Physician teams who respond to cardiac arrests and offer treatments beyond the scope of ambulance service clinicians. Following a review of practice and appraisal of evidence the investigators developed an additional algorithm for cases of adult medical cardiac arrest with refractory shockable rhythms. This adds to but does not replace the Advanced Life Support algorithm and includes:

• Delivering shocks with the LUCAS mechanical CPR device running
• After 5 shocks have been delivered placing new pads in the Anterior Posterior (AP) position
• Delivering shocks using the TVAA Tempus Pro defibrillator rather than the Ambulance Service defibrillator. This bundle was based on recommendations from ILCOR and the Resus Council (UK) Advanced Life Support manual and was launched in October 2021.

Conditions

Cardiac Arrest; Ventricular Fibrillation; Ventricular Tachycardia

Keywords

cardiac arrest; Refractory shockable rhythm; defibrillation

Outcome Measures

Primary Outcomes (1)

• ROSC at hospital

  ROSC at hospital

  within 24 hours of arrest

Secondary Outcomes (1)

• PLE rate

  within 24 hours of arrest

Other Outcomes (1)

• Total defibrillation shocks

  within 24 hours of arrest

Study Arms (2)

Before intervention

Standard care as per ALS guidelines prior to October 2021

After intervention

Enhanced cardiac arrest management as per TVAA guideline from October 2021 onwards

Other: Enhanced cardiac arrest bundle

Interventions

Enhanced cardiac arrest bundle OTHER

* Delivering shocks with the LUCAS mechanical CPR device running * After 5 shocks have been delivered placing new pads in the Anterior Posterior (AP) position * Delivering shocks using the TVAA Tempus Pro defibrillator rather than the Ambulance Service defibrillator.

Also known as: Vector change defibrillation

After intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adult patients with medical cardiac arrest attended by TVAA, in refractory shockable rhythms (defined as continuous VF or VT after 5 shocks).

You may qualify if:

• adult patients with medical cardiac arrest
• in refractory shockable rhythms (defined as continuous VF or VT after 5 shocks).

You may not qualify if:

• traumatic cardiac arrests
• cardiac arrests where the VF/VT was recurrent (could be terminated but then restarted) rather than refractory (unable to get the patient out of the shockable rhythm). Refractory VF refers to VF that persists despite shock delivery (i.e. shock-resistant VF). This is distinguished from recurrent VF, which is VF that re-appears after it has been terminated (2). In this study refractory would be defined as continuous VF or VT after 5 shocks.

Sponsors & Collaborators

• Thames Valley Air Ambulance: lead

Study Sites (1)

Thames Valley Air Ambulance

Oxford, Oxfordshire, United Kingdom

RECRUITING

MeSH Terms

Conditions

Heart Arrest; Ventricular Fibrillation; Tachycardia, Ventricular

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Arrhythmias, Cardiac; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Tachycardia; Cardiac Conduction System Disease

Central Study Contacts

James Raitt, MBChB

CONTACT

0300 999 0135; james.raitt@tvairambulance.org.uk

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Audit, Improvement and Research Lead

Study Record Dates

• First Submitted: May 22, 2023
• First Posted: July 3, 2023
• Study Start: May 1, 2023
• Primary Completion: June 30, 2023
• Study Completion: September 1, 2023
• Last Updated: July 3, 2023

Record last verified: 2023-06

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)