SNPeCPR In Cardiac Arrest REsuscitation
NCT02225561 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 1
Last updated 2020-01-10
Summary
Approximately 50,000 patients are victims of out of hospital cardiac arrest every year in France. Despite cardiopulmonary resuscitation (CPR) and many studies on the topic resuscitation survival after cardiac arrest remains low (1-8%) and has not changed significantly over the past five decades.It has recently been shown that the combination of different non-invasive therapies, cardiopulmonary resuscitation with mechanical CPR with automated compression / decompression and an impedance threshold device, can increase the rate of return of spontaneous circulation and short and long term survival after cardiac arrest.We propose to study a new cardiopulmonary resuscitation called SNPeCPR (Sodium nitroprusside enhanced cardiopulmonary resuscitation), which includes two components:a) a mechanical component: cardiopulmonary resuscitation with automated mechanical external chest compression and an impedance threshold deviceb) a pharmacological component: sodium nitroprusside, an effective arterial vasodilator that decrease vascular resistance, and improve flow in vital organs.Our hypothesis is that SNPeCPR should improve the return of spontaneous circulation rate during cardiac arrest.
Conditions
- Cardiopulmonary Arrest
Interventions
- PROCEDURE
-
pharmaco- mechanical optimization
Getting started as soon as possible cardiopulmonary resuscitation (CPR) mechanical ( LUCAS 2) with inspiratory impedance valve ( ResQPOD ) performed according to the 2015 recommendations of the European Resuscitation Council . It will be carried out continuously without a break for control pulse until the first defibrillation attempt. As soon the peripheral intravenous or intraosseous line is set the intervention group will receive an injection of 2 mg of sodium nitroprusside. 4 minutes after the first injection, a second and last injection of 1 mg of sodium nitroprusside will be realized.- The preparation procedure of the sodium nitroprusside will be: * Using a "pomping needle" and the provided syringe 4 ml of the solvent (Water for Injections, WFI) will be take. * The 4 ml of WFI will be empty in the 50 mg vial of lyophilisate sodium nitroprusside to solubilize the product. * Always with the needle and 20 ml syringe, the 4 ml of this solution (50 mg in 4 ml) will be collect.
- PROCEDURE
-
mechanical optimization only
Getting started as soon as possible cardiopulmonary resuscitation (CPR) mechanical ( LUCAS 2) with inspiratory impedance valve ( ResQPOD ) performed according to the 2015 recommendations of the European Resuscitation Council . It will be carried out continuously without a break for control pulse until the first defibrillation attempt.
Sponsors & Collaborators
-
Assistance Publique - Hôpitaux de Paris
lead OTHER
Principal Investigators
-
Patrick PLAISANCE, MD, PhD · Assistance Publique - Hôpitaux de Paris
Study Design
- Allocation
- RANDOMIZED
- Purpose
- OTHER
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 75 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2015-01-02
- Primary Completion
- 2017-07-02
- Completion
- 2018-01-02
Countries
- France
Study Locations
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