NCT05474170

Brief Summary

The International Liaison Committee on Resuscitation regularly publishes a Consensus on Science with Treatment Recommendations but guidelines can nevertheless differ when knowledge gaps persist. In case of pediatric cardiac arrest, the American Heart Association recommends following the adult resuscitation sequence i.e., starting with chest compressions. Conversely, the European Resuscitation Council advocates the delivery of 5 initial rescue breaths before starting chest compressions. Carrying out a randomized trial in children in cardiac arrest to assess the impact of these strategies would prove particularly challenging and ethical concerns may prevent such a trial from being performed. This will be a superiority, cross-over randomized trial whose goal is to determine the impact of these 2 resuscitation sequences on alveolar ventilation in a pediatric model of cardiac arrest. While not definitive, its results could help fill part of the current knowledge gap.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
28

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2022

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 18, 2022

Completed
8 days until next milestone

First Posted

Study publicly available on registry

July 26, 2022

Completed
1 month until next milestone

Study Start

First participant enrolled

September 1, 2022

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2022

Completed
Last Updated

November 12, 2024

Status Verified

November 1, 2024

Enrollment Period

Same day

First QC Date

July 18, 2022

Last Update Submit

November 9, 2024

Conditions

Outcome Measures

Primary Outcomes (1)

  • Alveolar ventilation

    The alveolar ventilation will be determined by subtracting the dead space volume from each ventilation. According to the appropriate Best Guess formula, a 9-month old infant should weigh around 9 kg (0.5 x age in months + 4.5). Using the formula proposed by Numa and Newth, this corresponds to a dead space of around 25 ml.

    1 minute

Secondary Outcomes (7)

  • The total number of ventilations

    1 minute

  • The proportion of ventilations within, above and below the target volume

    1 minute

  • The alveolar ventilation obtained without taking ventilation volumes over 70 ml into account

    1 minute

  • The proportion of compressions of correct depth

    1 minute

  • The proportion of chest compressions within, above and below the target rate.

    1 minute

  • +2 more secondary outcomes

Study Arms (2)

AHA --> ERC

EXPERIMENTAL

This group will first apply the AHA resuscitation sequence, then the ERC one

Other: AHA resuscitation sequenceOther: ERC resuscitation sequence

ERC --> AHA

ACTIVE COMPARATOR

This group will first apply the ERC resuscitation sequence, then the AHA one

Other: AHA resuscitation sequenceOther: ERC resuscitation sequence

Interventions

Starting the cardiopulmonary resuscitation by following the AHA guideline, meaning starting with 15 chest compressions, followed by 2 ventilations

AHA --> ERCERC --> AHA

Starting the cardiopulmonary resuscitation by following the ERC guideline, meaning starting with 5 initial ventilations, then alternating 15 chest compressions with 2 ventilations

AHA --> ERCERC --> AHA

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Being issued from one of the following profession: Emergency medical technicians (EMTs), paramedics, nurses and physicians

You may not qualify if:

  • Being member of the study team

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Swiss Prehospital Research Day

Neuchâtel, Canton of Neuchâtel, 2000, Switzerland

Location

Related Publications (1)

  • Suppan L, Jampen L, Siebert JN, Zund S, Stuby L, Ozainne F. Impact of Two Resuscitation Sequences on Alveolar Ventilation during the First Minute of Simulated Pediatric Cardiac Arrest: Randomized Cross-Over Trial. Healthcare (Basel). 2022 Dec 5;10(12):2451. doi: 10.3390/healthcare10122451.

    PMID: 36553975BACKGROUND

Related Links

MeSH Terms

Conditions

Heart ArrestPrecursor Cell Lymphoblastic Leukemia-Lymphoma

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular DiseasesLeukemia, LymphoidLeukemiaNeoplasms by Histologic TypeNeoplasmsHematologic DiseasesHemic and Lymphatic DiseasesLymphoproliferative DisordersLymphatic DiseasesImmunoproliferative DisordersImmune System Diseases

Study Officials

  • Laurent Suppan, MD

    University of Geneva Hospitals and Faculty of Medicine

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
Data extraction will be fully automated and the statistician will not know the identity of the participants or the sequence they were allocated to.
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

July 18, 2022

First Posted

July 26, 2022

Study Start

September 1, 2022

Primary Completion

September 1, 2022

Study Completion

September 1, 2022

Last Updated

November 12, 2024

Record last verified: 2024-11

Data Sharing

IPD Sharing
Will share

Anonymized data set will be made publicly available on the Digital Commons Data repository

Time Frame
Data will be available after publication of the results
Access Criteria
Publicly available

Locations