Cardiac Arrest (CA)
Conditions
Keywords
Advanced life support, Basic life support, Cardiac arrest, Cardiopulmonary resuscitation, CPR, ALS, BLS, Out-of-hospital cardiac arrest, OHCA, Mechanical chest compression devices, Mechanical CPR, Ventilation
Brief summary
To give chest compressions during cardiopulmonary resuscitation (CPR), mechanical chest compression devices can be used. During synchronous 30:2 CPR, the standard setting on these devices leave an automated 3-second chest compression pause after 30 compressions to facilitate caregivers in providing two ventilations. With this standard setting, research has shown that in less than half of ventilation pauses during CPR, those two ventilations are given. Increasing the ventilation pause duration to 5 seconds instead of 3 seconds is also an option following current guideline recommendations, and aligns with measured ventilation pause duration in manual CPR. Increasing pause duration to 5 seconds could result in an increased ventilation success rate. This multicenter randomized controlled trial will randomize LUCAS® mechanical compression devices to a standard setting of 3- or 5-second compression pauses. The main outcome will be the percentage of ventilation pauses in which two ventilations are successfully given. Secondary outcomes include the restoration of spontaneous circulation (ROSC), and the difference in (neurologically intact) survival. No study has been performed to evaluate this effect yet.
Interventions
OTHER5-second ventilation pause duration during mechanical CPR
The intervention is a 5-second lasting ventilation pause during mechanical CPR
OTHER3-second ventilation pause duration during mechanical CPR
The intervention is a 3-second lasting ventilation pause during mechanical CPR
Sponsors
Amsterdam UMC, location VUmc
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Intervention model description
Multicenter, single blinded (patients), randomized controlled trial
Eligibility
Sex/Gender
ALL
Age
16 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Adults (≥16 years of age) * OHCA patients with an attempt at cardiopulmonary resuscitation (CPR) by ambulance personnel * LUCAS® 3.1 has been used during the resuscitation attempt
Exclusion criteria
* Missing ambulance run report, missing or unclear impedance signal (measurement of resistance across the thorax), making it impossible to assess the number of ventilation pauses * Absence of a minimum of 3 assessable pauses intended for ventilation after connecting the LUCAS®
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of ventilation pauses in which two ventilations are given | From enrollment to end of mechanically assisted CPR by ambulance nurses (approximate maximum timeframe of 3 hours) | The difference in percentage of ventilation pauses in which two ventilations are given between the intervention and control group |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Survival to hospital discharge | From enrollment to hospital discharge (approximate maximum timeframe of 3 months) | The difference in percentage of participants with and without survival to hospital discharge |
| 30-day survival | From enrollment to 30 days after cardiac arrest | The difference in percentage of participants with and without survival at 30 days after the cardiac arrest |
| Return of spontaneous circulation (ROSC) | From enrollment to end of cardiac arrest treatment (approximate maximum timeframe of 5 hours) | The difference in percentage of participants with and without ROSC |
| Number of rhythm checks per five minutes, expected | From enrollment to prehospital termination of CPR or handover at hospital by ambulance nurses (approximate maximum timeframe of 3 hours) | The difference in the number of rhythm checks per five minutes performed with and without pausing the mechanical compression device, compared to the expected number of rhythm checks in that time frame (once every two minutes) between groups |
| Number of rhythm checks per five minutes, observed | From enrollment to prehospital termination of CPR or handover at hospital by ambulance nurses (approximate maximum of 3 hours) | The difference in the number of rhythm checks per five minutes performed with and without pausing the mechanical compression device, compared to the observed number of rhythm checks in that time frame (once every two minutes) between groups |
| Average tidal volume (ml) | From enrollment to end of intra-arrest ambulance monitor registration or flow/pressure measurements (approximate maximum timeframe of 3 hours) | Difference in average tidal volumes (ml) between groups |
| Average minute volume (ml/min) | From enrollment to end of intra-arrest ambulance monitor registration or flow/pressure measurements (approximate maximum timeframe of 3 hours) | Difference in average minute volumes (ml/min) between groups |
| Average respiratory rate (rate per minute) | From enrollment to end of intra-arrest ambulance monitor registration or flow/pressure measurements (approximate maximum timeframe of 3 hours) | Difference in average respiratory rate (rate per minute) between groups |
| Average airway pressure (cmH2O) | From enrollment to end of intra-arrest ambulance monitor registration or flow/pressure measurements (approximate maximum timeframe of 3 hours) | Difference average airway pressures (cmH2O) between groups |
| Chest compression fraction (CCF) | From enrollment to end of intra-arrest registration of ambulance monitor (approximate maximum timeframe of 3 hours) | Difference in chest compression fraction (CCF) between groups |
| Cerebral performance score (CPC score) at hospital discharge (CPC 1-2 vs. 3-4) | From enrollment to hospital discharge (approximate maximum timeframe of 3 months) | The difference in percentage of participants with a CPC of 1-2 (good neurological recovery) vs. 3-4 (poor neurological recovery) at hospital discharge CPC score system: 1. Normal (good cerebral performance) 2. Moderate disability (disabled but independent) 3. Severe disability (conscious but disabled and dependent) 4. Unconscious (coma or vegetative state) |
| Subjective experience of ambulance nurses with the mechanical CPR device and it's ventilation pause settings | After the last inclusion of the study, with an approximate time frame of 1-2 months to respond to the anonymous survey | Exploratory anonymous questionnaire of subjective experience of ambulance nurses with the mechanical CPR device (the LUCAS) and it's ventilation pause settings during the resuscitation. |
Countries
Netherlands
Contacts
CONTACTLotte C Doeleman, MD
CONTACTHans L van Schuppen, PhD
PRINCIPAL_INVESTIGATORPatrick Schober, MD, PhD
Amsterdam UMC
Outcome results
None listed