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

NCT06824961 | Not Yet Recruiting

• 1 other identifier: LUCASVP
• Study Type: interventional
• Target: 692
• Locations: 1 country
• Sites: 2

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.

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

Outcome Measures

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

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

Secondary Outcomes (12)

• Return of spontaneous circulation (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)

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

• Survival to hospital discharge

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

• 30-day survival

  From enrollment to 30 days after cardiac arrest

• Number of rhythm checks per five minutes, expected

  From enrollment to prehospital termination of CPR or handover at hospital by ambulance nurses (approximate maximum timeframe of 3 hours)

Study Arms (2)

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

Other: 5-second ventilation pause duration during 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

Other: 3-second ventilation pause duration during mechanical CPR

Interventions

5-second ventilation pause duration during mechanical CPR OTHER

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

Intervention - 5-second ventilation pause

3-second ventilation pause duration during mechanical CPR OTHER

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

Control - 3-second ventilation pauses

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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®

Sponsors & Collaborators

• Amsterdam UMC, location VUmc: lead

Study Sites (2)

Ambulance Amsterdam

Amsterdam, North Holland, 1075LB, Netherlands

Location

Regionale Ambulance Voorziening Kennemerland - Ambulancezorg GGD Kennemerland

Haarlem, North Holland, 2015CK, Netherlands

Location

MeSH Terms

Conditions

Heart Arrest; Out-of-Hospital Cardiac Arrest; Respiratory Aspiration

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Respiration Disorders; Respiratory Tract Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Patrick Schober, MD, PhD

  Amsterdam UMC

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Lotte C Doeleman, MD

CONTACT

+31205665969; l.c.doeleman@amsterdamumc.nl

Hans L van Schuppen, PhD

CONTACT

+31205665969; j.l.vanschuppen@amsterdamumc.nl

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator: Professor Emergency Medicine in Anesthesiology Dr. Patrick Schober, MD, PhD.

Model Details: Multicenter, single blinded (patients), randomized controlled trial

Study Record Dates

• First Submitted: January 21, 2025
• First Posted: February 13, 2025
• Study Start: March 1, 2025
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): April 1, 2027
• Last Updated: February 13, 2025

Record last verified: 2025-01

Locations

NL (2)