Clinical trial NCT06824961: Does Increasing the Compression Pause From 3 to 5 Seconds in Mechanical Compression Devices Increase Ventilation Success Rate and Return of Spontaneous Circulation?
Official title: Does Increasing the Compression Pause From 3 to 5 Seconds in Mechanical Compression Devices Increase Ventilation Success Rate and Return of Spontaneous Circulation?
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Cardiac Arrest (CA)
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
Lead sponsor: Amsterdam UMC, location VUmc
Sponsor class: OTHER
First posted: 2025-02-13
Enrollment: 692
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Multicenter, single blinded (patients), randomized controlled trial
Primary purpose: TREATMENT

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.


Eligibility criteria: 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®

Primary outcomes:
measure: Percentage of ventilation pauses in which two ventilations are given
timeFrame: From enrollment to end of mechanically assisted CPR by ambulance nurses (approximate maximum timeframe of 3 hours)
Secondary outcomes:
measure: Return of spontaneous circulation (ROSC)
timeFrame: From enrollment to end of cardiac arrest treatment (approximate maximum timeframe of 5 hours)
measure: Cerebral performance score (CPC score) at hospital discharge (CPC 1-2 vs. 3-4)
timeFrame: From enrollment to hospital discharge (approximate maximum timeframe of 3 months)
measure: Survival to hospital discharge
timeFrame: From enrollment to hospital discharge (approximate maximum timeframe of 3 months)
measure: 30-day survival
timeFrame: From enrollment to 30 days after cardiac arrest
measure: Number of rhythm checks per five minutes, expected
timeFrame: From enrollment to prehospital termination of CPR or handover at hospital by ambulance nurses (approximate maximum timeframe of 3 hours)
measure: Number of rhythm checks per five minutes, observed
timeFrame: From enrollment to prehospital termination of CPR or handover at hospital by ambulance nurses (approximate maximum of 3 hours)
measure: Average tidal volume (ml)
timeFrame: From enrollment to end of intra-arrest ambulance monitor registration or flow/pressure measurements (approximate maximum timeframe of 3 hours)
measure: Average minute volume (ml/min)
timeFrame: From enrollment to end of intra-arrest ambulance monitor registration or flow/pressure measurements (approximate maximum timeframe of 3 hours)
measure: Average respiratory rate (rate per minute)
timeFrame: From enrollment to end of intra-arrest ambulance monitor registration or flow/pressure measurements (approximate maximum timeframe of 3 hours)
measure: Average airway pressure (cmH2O)
timeFrame: From enrollment to end of intra-arrest ambulance monitor registration or flow/pressure measurements (approximate maximum timeframe of 3 hours)
measure: Chest compression fraction (CCF)
timeFrame: From enrollment to end of intra-arrest registration of ambulance monitor (approximate maximum timeframe of 3 hours)
measure: Subjective experience of ambulance nurses with the mechanical CPR device and it's ventilation pause settings
timeFrame: After the last inclusion of the study, with an approximate time frame of 1-2 months to respond to the anonymous survey
Other outcomes:
Locations:
city: Amsterdam
country: Netherlands
facility: Ambulance Amsterdam
state: North-Holland
city: Haarlem
country: Netherlands
facility: Regionale Ambulance Voorziening Kennemerland - Ambulancezorg GGD Kennemerland
state: North-Holland
Study officials:
affiliation: Amsterdam UMC
name: Patrick Schober, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: