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

NCT ID: NCT06824961

Last Updated: 2025-02-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

692 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-03-01

Study Completion Date

2027-04-01

Brief Summary

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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.

Detailed Description

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Conditions

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Cardiac Arrest (CA)

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Multicenter, single blinded (patients), randomized controlled trial
Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Intervention - 5-second ventilation pause

Patients in this group will have ventilation pauses lasting 5 seconds in between cardiac compressions given by mechanical CPR

Group Type EXPERIMENTAL

5-second ventilation pause duration during mechanical CPR

Intervention Type OTHER

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

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

Group Type ACTIVE_COMPARATOR

3-second ventilation pause duration during mechanical CPR

Intervention Type OTHER

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

Interventions

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5-second ventilation pause duration during mechanical CPR

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

Intervention Type OTHER

3-second ventilation pause duration during mechanical CPR

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

Intervention Type OTHER

Eligibility Criteria

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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®
Minimum Eligible Age

16 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Amsterdam UMC, location VUmc

OTHER

Sponsor Role lead

Responsible Party

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Prof. Dr. Patrick Schober

Principal Investigator: Professor Emergency Medicine in Anesthesiology Dr. Patrick Schober, MD, PhD.

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Patrick Schober, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Amsterdam UMC

Locations

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Ambulance Amsterdam

Amsterdam, North Holland, Netherlands

Site Status

Regionale Ambulance Voorziening Kennemerland - Ambulancezorg GGD Kennemerland

Haarlem, North Holland, Netherlands

Site Status

Countries

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Netherlands

Central Contacts

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Lotte C Doeleman, MD

Role: CONTACT

+31205665969

Hans L van Schuppen, PhD

Role: CONTACT

+31205665969

Facility Contacts

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Durk S Linzel, MD

Role: primary

+31686897621

Ed Bleijenberg

Role: backup

Monique Theunissen

Role: primary

+31624920614

Anja Radstok

Role: backup

Other Identifiers

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LUCASVP

Identifier Type: -

Identifier Source: org_study_id

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