Does Increasing the Compression Pause From 3 to 5 Seconds in Mechanical Compression Devices Increase Ventilation Success Rate and Return of Spontaneous Circulation?

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age16+
SponsorAmsterdam UMC, location VUmc

About this trial

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

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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®

Trial design

Design model

Parallel

Treatments tested in this trial

  • 5-second ventilation pause duration during mechanical CPR

    Other intervention

    The intervention is a 5-second lasting ventilation pause during mechanical CPR

  • 3-second ventilation pause duration during mechanical CPR

    Other intervention

    The intervention is a 3-second lasting ventilation pause during mechanical CPR

Treatment groups

692 Participants
are divided into 2 treatment groups
Group A: Intervention - 5-second ventilation pauseExperimental treatment 1 intervention
Group B: Control - 3-second ventilation pausesActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

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

Time frame
From enrollment to end of mechanically assisted CPR by ambulance nurses (approximate maximum timeframe of 3 hours)

Secondary outcomes

1

Return of spontaneous circulation (ROSC)

The difference in percentage of participants with and without ROSC

Time frame
From enrollment to end of cardiac arrest treatment (approximate maximum timeframe of 5 hours)
2

Cerebral performance score (CPC score) at hospital discharge (CPC 1-2 vs. 3-4)

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)

Time frame
From enrollment to hospital discharge (approximate maximum timeframe of 3 months)
3

Survival to hospital discharge

The difference in percentage of participants with and without survival to hospital discharge

Time frame
From enrollment to hospital discharge (approximate maximum timeframe of 3 months)
4

30-day survival

The difference in percentage of participants with and without survival at 30 days after the cardiac arrest

Time frame
From enrollment to 30 days after cardiac arrest

Other outcomes

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