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NCT Number: NCT06824961

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

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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Key information

Conditions

Cardiac Arrest (CA) Cardiovascular Diseases Heart Arrest Heart Diseases Out-of-Hospital Cardiac Arrest Pathologic Processes Pathological Conditions, Signs and Symptoms Respiration Disorders Respiratory Aspiration Respiratory Tract Diseases

Age range

16 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ambulance Amsterdam, Amsterdam, North Holland, Netherlands

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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®

Treatment and study plan

5-second ventilation pause duration during mechanical CPR

Other

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

3-second ventilation pause duration during mechanical CPR

Other

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

Primary outcomes

  1. Percentage of ventilation pauses in which two ventilations are given

    Time frame: 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 outcomes

  1. Return of spontaneous circulation (ROSC)

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

    The difference in percentage of participants with and without ROSC

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

    Time frame: 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:

    • Normal (good cerebral performance)
    • Moderate disability (disabled but independent)
    • Severe disability (conscious but disabled and dependent)
    • Unconscious (coma or vegetative state)

  3. Survival to hospital discharge

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

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

  4. 30-day survival

    Time frame: 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

  5. Number of rhythm checks per five minutes, expected

    Time frame: 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

  6. Number of rhythm checks per five minutes, observed

    Time frame: 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

  7. Average tidal volume (ml)

    Time frame: 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

  8. Average minute volume (ml/min)

    Time frame: 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

  9. Average respiratory rate (rate per minute)

    Time frame: 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

  10. Average airway pressure (cmH2O)

    Time frame: 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

  11. Chest compression fraction (CCF)

    Time frame: 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

  12. Subjective experience of ambulance nurses with the mechanical CPR device and it's ventilation pause settings

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Hans L van Schuppen, PhD

CONTACT

[email protected]

+31205665969

Lotte C Doeleman, MD

CONTACT

[email protected]

+31205665969

Sponsors and collaborators

Lead sponsor

Amsterdam UMC, location VUmc

Other

Registry information

Acronym: LUCASVP

Important dates

Study start
2025
Primary completion
2026
Study completion
2027
First posted
Feb 13, 2025
Registry last updated
Feb 13, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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