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Pediatric ALLNCT05498402

Effect of IAM With an I-gel® on Ventilation Parameters in Simulated Pediatric OHCA

A study testing i-gel ® device and bag-valve-mask ventilation in people with Pediatric ALL and Cardiac Arrest, run by Geneve TEAM Ambulances at 4 sites 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

Pediatric cardiac arrest occurs most in the prehospital setting. Most of them are due to respiratory failure (e.g., trauma, drowning, respiratory distress), where hypoxia leads to cardiac arrest. Read more about this study

Who is it for?
Any ageHealthy volunteers can take part
What is being tested?
i-gel ® device and bag-valve-mask ventilation
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
34 participants
Where
4 sitesSwitzerland
Study dates
30 Jan 2023to 13 Jun 2023
Phase
Interventional
Are there results?
None posted in the registry

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 a registered EMT, or paramedic

Who cannot join

  • Member of the study team

Trial locations and contacts

4 sites in 1 country.

Switzerland4 sites
  • ACE Genève Ambulances

    Chêne-Bougeries, Canton of Geneva, 1224

  • Genève TEAM Ambulances

    Geneva, 1201

  • SK Ambulances

    Geneva, 1211

  • Ambulances de la Ville de Sion

    Sion, Valais, 1950

Other trials in Switzerland

About this study

Official title: Effect of Intermediate Airway Management Using an I-gel® on Ventilation Parameters in Simulated Pediatric Out-of-Hospital Cardiac Arrest: Protocol for a Randomized Crossover Trial

Pediatric cardiac arrest occurs most in the prehospital setting. Most of them are due to respiratory failure (e.g., trauma, drowning, respiratory distress), where hypoxia leads to cardiac arrest. Generally, emergency medical services (EMS) first use basic airway management techniques i.e., the use of a bag-valve-mask (BVM) device, to restore oxygenation in pediatric OHCA victims. However, these devices present many drawbacks and limitations. Intermediate airway management, i.e., the use of SGA devices, especially the i-gel® has several advantages. It has been shown to enhance both circulatory and ventilatory parameters. There is increasing evidence that IAM devices can safely be used in children. In two pediatric studies of OHCA, American paramedics had significantly higher success rates with SGA devices than with TI. A neonatal animal model showed that the use of SGA was feasible and non-inferior to TI in this population. However, data regarding the effect of IAM with an i-gel® versus the use of a BVM on ventilation parameters during pediatric OHCA is missing. The hypothesis underlying this study is that, in case of pediatric OHCA, early insertion of an i-gel® device without prior BVM ventilation should improve ventilation parameters in comparison with the standard approach consisting in BVM ventilations.

Read the detailed description

Pediatric cardiac arrest is a high-risk, low-frequency event associated with death or severe neurological sequelae in survivors. Most occur in the prehospital setting. Despite advances in resuscitation science and survival improvement over the last decades, survival remains low, with only approximately 6% to 20% of children surviving to hospital discharge after pediatric out-of-hospital cardiac arrest (OHCA). Most triggers of pediatric OHCA are respiratory in nature, with sudden infant death syndrome, trauma and drowning among the main etiologies, where hypoxia leads to cardiac arrest. Prompt and effective airway management is therefore paramount when responding to a pediatric OHCA. Any delay in intermediate or advanced airway management has been associated with a decreased chance of survival. The debate about the optimal airway management strategy that should be used in pediatric OHCA is, however, still ongoing.

Generally, emergency medical services (EMS) first use basic airway management techniques i.e., the use of a bag-valve-mask (BVM) device, to restore oxygenation in pediatric OHCA victims. However, these devices present many drawbacks and limitations. First, airtightness must be ensured to enable adequate oxygenation. Second, the use of BVM is associated with gastric air insufflation. This can alter oxygenation by restricting total lung capacity and, consequently, lung compliance. Since decreased lung compliance requires the use of higher pressures to reach the same tidal volume, gastric inflation can indirectly impair venous return. In addition, chest compressions during cardiopulmonary resuscitation (CPR) must be interrupted to provide ventilations when basic airway management devices are used. However, these interruptions decrease coronary and cerebral blood flow and should be minimized as they have been associated with decreased survival both in animals and humans.

On the other hand, advanced airway management, i.e., tracheal intubation (TI), provides optimal airtightness -thereby avoiding gastric inflation and risk of regurgitation- while allowing the provision of asynchronous ventilations during CPR. However, advanced airway management requires advanced skills that must be maintained through regular practice. Depending on the regional context, skilled prehospital providers may not be immediately available, if at all. This is particularly important when taking care of critically ill children, whom many consider difficult to intubate. The failure rate of TI at first attempt in case of pediatric CPR is high, even in the hospital setting, and associated with unfavorable neurological and survival outcomes. Recently, a registry-based study reported these outcomes to be worse after pediatric OHCA when emergency physicians used TI rather than supraglottic airway (SGA) devices. The interpretation of these results is however limited by the lack of data regarding physician experience and TI attempts.

In line with the above listed limitations of basic or advanced airway management devices, intermediate airway management (IAM) i.e., the use of SGA devices [18], could represent a valuable alternative in prehospital settings. One of the best studied SGA devices is the i-gel®, which is both easy and fast to insert, and provides high leak pressures. Its use is associated with a high overall success rate and is easily remembered. Regurgitation and aspiration are not more frequent with IAM devices than with TI and are much less likely than when a BVM device is used. The use of an i-gel® enables continuous chest compressions in most cases, and a higher first rate of successful initial ventilation. This device has been found to increase the chest compression fraction (CCF) and improve ventilations parameters in an adult model of OHCA. In real OHCA, compared to TI, similar outcomes at 30 days and 6 months were found.

There is increasing evidence that IAM devices can safely be used in children. In two pediatric studies of OHCA, American paramedics had significantly higher success rates with SGA devices than with TI. A neonatal animal model showed that the use of SGA was feasible and non-inferior to TI in this population. However, data regarding the effect of IAM with an i-gel® versus the use of a BVM on ventilation parameters during pediatric OHCA is missing. The hypothesis underlying this study is that, in case of pediatric OHCA, early insertion of an i-gel® device without prior BVM ventilation should improve ventilation parameters in comparison with the standard approach consisting in BVM ventilations.

For this purpose, a prospective, multicenter, crossover, randomized controlled trial with two groups will be conduct in four EMS in different French-speaking part of Switzerland. This will be a simulation-based study.

Being tested
i-gel ® device, bag-valve-mask ventilation
Medical subject headings
Precursor Cell Lymphoblastic Leukemia-Lymphoma, Heart Arrest

What participants receive

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

  • i-gel ® deviceDevice

    Ventilations will be delivered through an i-gel ® device

  • bag-valve-mask ventilationDevice

    Ventilations will be delivered using a bag-valve-mask

Study groups in NCT05498402
Study groupRoleWhat they receive
Bag-valve-mask ventilationActive comparatorProviders will perform a cardiopulmonary resuscitation, and deliver ventilations using a bag-valve-mask
Receives: Device: bag-valve-mask ventilation
Supraglottic airway device ventilationExperimentalProviders will perform a cardiopulmonary resuscitation, and deliver ventilations using an i-gel® supraglottic airway device
Receives: Device: i-gel ® device

What is being measured

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

  1. Alveolar ventilation per minute

    It will be determined by subtracting the dead space volume from each ventilation, then multiplied by the ventilations' count, and divided by the duration of the ventilation period (i.e., 10 minutes - time to the first ventilation). The simulated child's dead space volume corresponds to about 27 ml using the formula proposed by Numa and Newth. The physiological tidal volume range is of 5 to 8 ml/kg, corresponding to 45 to 72 ml for the simulated child's.

    Measured: 10 minutes of scenario

Secondary outcomes (11)
  1. The proportion, and number of ventilations below, within and over the target volume

    The target volume is 45 to 72 ml.

    Measured: 10 minutes of scenario

  2. The time to the first efficient ventilation

    Corresponds to the time elapsed between T0 (the first therapeutical action) and the first efficient ventilation (equal or superior to 45 ml)

    Measured: 10 minutes of scenario

  3. The time to the first compression

    Corresponds to the time elapsed between T0 (the first therapeutical action) and the first compression

    Measured: 10 minutes of scenario

  4. The chest compression fraction

    Corresponds to the time during which compressions have been performed on the total CPR time

    Measured: 10 minutes of scenario

  5. The chest compression rate

    Corresponds to the number of compressions delivered by minute

    Measured: 10 minutes of scenario

  6. The proportion of chest compressions below, within and over the target rate

    The target rate is 100 to 120 compressions per minute

    Measured: 10 minutes of scenario

  7. The compression depth

    Corresponds to the depth of the chest compressions

    Measured: 10 minutes of scenario

  8. The proportion of chest compressions below and within the target depth

    The threshold is 4.3 cm (corresponding to one third of the manikin's measured anteroposterior chest depth)

    Measured: 10 minutes of scenario

  9. The proportion of complete chest recoil

    Corresponds to the proportions of compression released to at least 5 mm from the baseline

    Measured: 10 minutes of scenario

  10. The time to first epinephrine injection

    Corresponds to the time elapsed between the first therapeutical action (T0) and the time-point where epinephrine is administered

    Measured: 10 minutes of scenario

  11. The proportion of scenarios in which epinephrine is administered within 5 minutes

    The part of scenarios where epinephrine was administered following the recommandations

    Measured: 10 minutes of scenario

Timeline

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

  1. First posted12 Aug 2022
  2. Study start30 Jan 2023
  3. Primary completion13 Jun 2023
  4. Study completion13 Jun 2023

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
Model description
Prospective, multicenter, crossover, simulation-based, randomized controlled trial
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
34 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05498402
Sponsor's protocol ID
CPR-6
Status last verified
Sep 2023
First submitted
9 Aug 2022
Last updated
18 Sep 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: The study protocol will be published in a peer-reviewed journal. The data will be freely available on Yareta

Publications

  • Stuby L, Bourgeois L, Tinembart JM, Muhlemann E, Thurre D, Siebert JN, Suppan L. Effect of intermediate airway management on ventilation parameters in simulated paediatric out-of-hospital cardiac arrest: a multicentre randomised crossover trial. Swiss Med Wkly. 2025 May 16;155:4079. doi: 10.57187/s.4079.

    PubMed 40450752

Questions about this trial

What is this clinical trial studying?

A study testing i-gel ® device and bag-valve-mask ventilation in people with Pediatric ALL and Cardiac Arrest, run by Geneve TEAM Ambulances at 4 sites 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 18 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Alveolar ventilation per minute (time frame: 10 minutes of scenario). 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 NCT05498402, 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 18 Sep 2023.

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