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Cardiopulmonary ArrestNCT05474170

Impact of 2 Resuscitation Sequences on Management of Simulated Pediatric Cardiac Arrest

A study testing AHA resuscitation sequence and ERC resuscitation sequence in people with Cardiopulmonary Arrest and Pediatric ALL, run by Geneve TEAM Ambulances at 1 site in Switzerland.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Any ageHealthy volunteers can take part
What is being tested?
AHA resuscitation sequence and ERC resuscitation sequence
Could I receive a placebo?
No, everyone receives an active treatment
How many people
28 participants
Where
1 siteSwitzerland
Study dates
1 Sep 2022to 1 Sep 2022
Phase
Interventional
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Any age
  • All sexes
  • Healthy volunteers accepted
  • Child, Adult, Older adult

Who may be able to join

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

Who cannot join

  • Being member of the study team

Trial locations and contacts

1 site in 1 country.

Switzerland1 site
  • Swiss Prehospital Research Day

    Neuchâtel, Canton of Neuchâtel, 2000

Other trials in Switzerland

About this study

Official title: Impact of 2 Resuscitation Sequences on Alveolar Ventilation During the First Minute of Simulated Pediatric Cardiac Arrest: Randomized Cross-Over Trial

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.

Read the detailed description

This will be a randomized, cross-over, superiority trial. The intention is to carry it out on the first Prehospital Research Day which will be held on September 1st, 2022, i.e., on a single date. This event will take place at a single center in Neuchâtel, Switzerland. If the intended sample size cannot be reached on this day, or if technical issues prevent data from being collected or extracted, other study sites will be considered.

Participant recruitment will be conducted online. A web-based platform based on the Joomla 4 (Open Source Matters, New York, USA) content management system will be specifically created for the purpose of this study. The Event Booking 4 component (Joomdonation, Hanoi, Vietnam) will be used to create 20-minute time slots. Demographic data will be collected during the registration process. Consent will be gathered electronically.

Since the objective of this study is to assess the impact of basic airway management and ventilation maneuvers only, there will be no stratification since all the professionals eligible for inclusion should be equally proficient in basic airway management. Furthermore, all participants will be able to practice this skill on a manikin identical to the one used to perform the study. This training will not be time limited and will take place immediately before the sequence during which data will be collected.

An investigator who will not be present during the resuscitation sequences will create stacks of opaque, sealed envelopes. Each stack of 10 envelopes will contain an equal number of American Heart Association (AHA) and European Resuscitation Council (ERC) allocations. Randomization will take place after the training session. The first leader will choose and open one of the envelopes placed on a table in random order by one of the on-site investigators. This will determine the resuscitation sequence which will first be used by the team.

A SimBaby manikin (Laerdal SimBaby, Laerdal Medical, Stavanger, Norway) will be used in this study. The SimBaby is a realistic manikin representing a 9-month-old infant. The manikin weighs 4.9 kg and is 71 cm tall. It is accompanied with a dedicated multiparameter monitor/defibrillator. Back compensation, using a folded blanket, will be applied. An appropriately sized bag-valve-mask (BVM) device will be ready for use next to the manikin. The defibrillation pads will be already attached.

Participants will be told that they are facing a 9-month old infant who suddenly collapsed. They will be told that there is no foreign body airway obstruction and that the infant is in cardiac arrest.

Each team of two people will perform 4 resuscitation sequences of one minute each. Each participant will act as leader for two successive resuscitation sequences, the first of which will be carried out according to the random allocation described above. The scenario will be identical for all resuscitation sequences. After completing these two sequences, participants will exchange their roles, and the new leader will pick up another opaque, sealed envelope. The content of this envelope will determine the resuscitation sequence the newly appointed leader will have to use first.

The timer will start (T0) at the moment when the first action (chest compression or ventilation) will have been performed and will stop exactly after 60 seconds.

It will not be possible to blind the participants or the on-site investigators as to the design of the study or even to the allocation of the participants. Nevertheless, the outcomes will not be communicated to the participant. In addition, data extraction will be fully automated and the statistician will not know the identity of the participants or the sequence they were allocated to.

Being tested
AHA resuscitation sequence, ERC resuscitation sequence
Medical subject headings
Heart Arrest, Precursor Cell Lymphoblastic Leukemia-Lymphoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • AHA resuscitation sequenceOther

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

  • ERC resuscitation sequenceOther

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

Study groups in NCT05474170
Study groupRoleWhat they receive
AHA --> ERCExperimentalThis group will first apply the AHA resuscitation sequence, then the ERC one
Receives: Other: AHA resuscitation sequence; Other: ERC resuscitation sequence
ERC --> AHAActive comparatorThis group will first apply the ERC resuscitation sequence, then the AHA one
Receives: Other: AHA resuscitation sequence; Other: ERC resuscitation sequence

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Median Alveolar Ventilation

    The alveolar ventilation was 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. The value reported was the median [quartiles] over the first minute.

    Measured: 1 minute

Secondary outcomes (7)
  1. The Total Number of Ventilations

    This will be the count of the number of ventilations delivered during the one-minute scenario

    Measured: 1 minute

  2. The Percentage of Ventilations Within, Above and Below the Target Volume

    According to the manikin's manufacturer, the target is 30 to 70 ml. >70 ml was considered "Above" and <30 ml was considered below.

    Measured: 1 minute

  3. The Alveolar Ventilation Obtained Without Taking Ventilation Volumes Over 70 ml Into Account, Reported as the Median Value of the Ventilations Over the First Minute.

    This is similar to the primary outcome, but for this analysis, all ventilations were individually capped at 70 ml. The value reported was the median [quartiles] over the first minute.

    Measured: 1 minute

  4. The Percentage of Compressions of Correct Depth

    The chest compression were considered correct if ≥ 4.3 cm, corresponding to one third of the height of the manikin's chest i.e., 13 cm). A second target of 3 cm or more was also reported.

    Measured: 1 minute

  5. The Percentage of Chest Compressions Within, Above and Below the Target Rate.

    According to the guidelines, the target is 100 to 120 compressions per minute

    Measured: 1 minute

  6. The Chest Compression Fraction (CCF)

    This corresponds to the time with compressions on the total time of the cardiopulmonary resuscitation sequence

    Measured: 1 minute

  7. The Percentage of Compressions With Adequate Chest Recoil

    This corresponds to the proportion of compressions enough relaxed to let complete heart relaxation

    Measured: 1 minute

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 Jul 2022
  2. Study start1 Sep 2022
  3. Primary completion1 Sep 2022
  4. Study completion1 Sep 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Crossover
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
28 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05474170
Sponsor's protocol ID
CPR-AHA/ERC
Status last verified
Mar 2026
First submitted
18 Jul 2022
Last updated
3 Apr 2026
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: Anonymized data set will be made publicly available on the Digital Commons Data repository

Publications

  • 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.

    PubMed 36553975

Questions about this trial

What is this clinical trial studying?

A study testing AHA resuscitation sequence and ERC resuscitation sequence in people with Cardiopulmonary Arrest and Pediatric ALL, run by Geneve TEAM Ambulances at 1 site in Switzerland.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 3 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 3 Apr 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Median Alveolar Ventilation (time frame: 1 minute). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05474170, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Apr 2026.

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