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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention - 5-second ventilation pause | Experimental | Patients in this group will have ventilation pauses lasting 5 seconds in between cardiac compressions given by mechanical CPR |
|
| Control - 3-second ventilation pauses | Active Comparator | Patients in this group will have ventilation pauses lasting the standard 3 seconds in between cardiac compressions given by mechanical CPR |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 5-second ventilation pause duration during mechanical CPR | Other | The intervention is a 5-second lasting ventilation pause during mechanical CPR |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of ventilation pauses in which two ventilations are given | The difference in percentage of ventilation pauses in which two ventilations are given between the intervention and control group | From enrollment to end of mechanically assisted CPR by ambulance nurses (approximate maximum timeframe of 3 hours) |
| Measure | Description | Time Frame |
|---|---|---|
| Return of spontaneous circulation (ROSC) | The difference in percentage of participants with and without ROSC | From enrollment to end of cardiac arrest treatment (approximate maximum timeframe of 5 hours) |
| Cerebral performance score (CPC score) at hospital discharge (CPC 1-2 vs. 3-4) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Lotte C Doeleman, MD | Contact | +31205665969 | l.c.doeleman@amsterdamumc.nl | |
| Hans L van Schuppen, PhD | Contact | +31205665969 | j.l.vanschuppen@amsterdamumc.nl |
| Name | Affiliation | Role |
|---|---|---|
| Patrick Schober, MD, PhD | Amsterdam UMC | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ambulance Amsterdam | Amsterdam | North Holland | 1075LB | Netherlands |
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Multicenter, single blinded (patients), randomized controlled trial
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| 3-second ventilation pause duration during mechanical CPR | Other | The intervention is a 3-second lasting ventilation pause during mechanical CPR |
|
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:
|
| From enrollment to hospital discharge (approximate maximum timeframe of 3 months) |
| Survival to hospital discharge | The difference in percentage of participants with and without survival to hospital discharge | From enrollment to hospital discharge (approximate maximum timeframe of 3 months) |
| 30-day survival | The difference in percentage of participants with and without survival at 30 days after the cardiac arrest | From enrollment to 30 days after cardiac arrest |
| Number of rhythm checks per five minutes, expected | 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 | From enrollment to prehospital termination of CPR or handover at hospital by ambulance nurses (approximate maximum timeframe of 3 hours) |
| Number of rhythm checks per five minutes, observed | 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 | From enrollment to prehospital termination of CPR or handover at hospital by ambulance nurses (approximate maximum of 3 hours) |
| Average tidal volume (ml) | Difference in average tidal volumes (ml) between groups | From enrollment to end of intra-arrest ambulance monitor registration or flow/pressure measurements (approximate maximum timeframe of 3 hours) |
| Average minute volume (ml/min) | Difference in average minute volumes (ml/min) between groups | From enrollment to end of intra-arrest ambulance monitor registration or flow/pressure measurements (approximate maximum timeframe of 3 hours) |
| Average respiratory rate (rate per minute) | Difference in average respiratory rate (rate per minute) between groups | From enrollment to end of intra-arrest ambulance monitor registration or flow/pressure measurements (approximate maximum timeframe of 3 hours) |
| Average airway pressure (cmH2O) | Difference average airway pressures (cmH2O) between groups | From enrollment to end of intra-arrest ambulance monitor registration or flow/pressure measurements (approximate maximum timeframe of 3 hours) |
| Chest compression fraction (CCF) | Difference in chest compression fraction (CCF) between groups | From enrollment to end of intra-arrest registration of ambulance monitor (approximate maximum timeframe of 3 hours) |
| Subjective experience of ambulance nurses with the mechanical CPR device and it's ventilation pause settings | 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. | After the last inclusion of the study, with an approximate time frame of 1-2 months to respond to the anonymous survey |
| Regionale Ambulance Voorziening Kennemerland - Ambulancezorg GGD Kennemerland | Haarlem | North Holland | 2015CK | Netherlands |
|
| ID | Term |
|---|---|
| D006323 | Heart Arrest |
| D058687 | Out-of-Hospital Cardiac Arrest |
| D053120 | Respiratory Aspiration |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D012120 | Respiration Disorders |
| D012140 | Respiratory Tract Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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