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

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.

Study Overview

• Status: Recruiting
• Conditions: Cardiac Arrest (CA)
• Intervention / Treatment: Other: 5-second ventilation pause duration during mechanical CPR; Other: 3-second ventilation pause duration during mechanical CPR

• Study Type: Interventional
• Enrollment (Estimated): 692
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Lotte C Doeleman, MD; Phone Number: +31205665969; Email: l.c.doeleman@amsterdamumc.nl
• Study Contact Backup: Name: Hans L van Schuppen, PhD; Phone Number: +31205665969; Email: j.l.vanschuppen@amsterdamumc.nl

Study Locations

• Netherlands
  • North Holland
    • Amsterdam, North Holland, Netherlands, 1075LB
      • Recruiting
      • Ambulance Amsterdam
      • Contact: Durk S Linzel, MD; Phone Number: +31686897621; Email: dlinzel@ambulanceamsterdam.nl
      • Contact: Ed Bleijenberg; Email: ebleijenberg@ambulanceamsterdam.nl
      • Principal Investigator: Durk S Linzel, MD
    • Haarlem, North Holland, Netherlands, 2015CK
      • Recruiting
      • Regionale Ambulance Voorziening Kennemerland - Ambulancezorg GGD Kennemerland
      • Contact: Monique Theunissen; Phone Number: +31624920614; Email: m.theunissen@wittekruis.nl
      • Contact: Anja Radstok; Email: a.radstok@wittekruis.nl
      • Principal Investigator: Monique Theunissen

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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®

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention - 5-second ventilation pause; Patients in this group will have ventilation pauses lasting 5 seconds in between cardiac compressions given by mechanical CPR	Other: 5-second ventilation pause duration during mechanical CPR; The intervention is a 5-second lasting ventilation pause during mechanical CPR
Active Comparator: Control - 3-second ventilation pauses; Patients in this group will have ventilation pauses lasting the standard 3 seconds in between cardiac compressions given by mechanical CPR	Other: 3-second ventilation pause duration during mechanical CPR; The intervention is a 3-second lasting ventilation pause during mechanical CPR

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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)

Secondary Outcome Measures

Outcome Measure	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)	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)	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

Collaborators and Investigators

• Sponsor: Amsterdam UMC, location VUmc
• Investigators: Principal Investigator: Patrick Schober, MD, PhD, Amsterdam UMC

Study record dates

Study Major Dates

• Study Start (Actual): January 15, 2026
• Primary Completion (Estimated): January 15, 2027
• Study Completion (Estimated): July 1, 2027

Study Registration Dates

• First Submitted: January 21, 2025
• First Submitted That Met QC Criteria: February 7, 2025
• First Posted (Actual): February 13, 2025

Study Record Updates

• Last Update Posted (Actual): August 21, 2026
• Last Update Submitted That Met QC Criteria: August 19, 2026
• Last Verified: August 1, 2026

More Information

Terms related to this study

• Keywords: ALS; Cardiac arrest; CPR; Basic life support; Cardiopulmonary resuscitation; BLS; Ventilation; Out-of-hospital cardiac arrest; Mechanical CPR; OHCA; Advanced life support; Mechanical chest compression devices
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Pathologic Processes; Heart Diseases; Respiratory Tract Diseases; Respiration Disorders; Pathological Conditions, Signs and Symptoms; Respiratory Aspiration; Heart Arrest; Out-of-Hospital Cardiac Arrest; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Autonomic Agents; Peripheral Nervous System Agents; Neurotransmitter Agents; Adrenergic alpha-Agonists; Adrenergic Agonists; Adrenergic Agents; Respiratory System Agents; Sympathomimetics; Vasoconstrictor Agents; Nasal Decongestants; Oxymetazoline
• Other Study ID Numbers: LUCASVP

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No