Clinical trial · Interventional
Effect of IAM With an I-gel® on Ventilation Parameters in Simulated Pediatric OHCA
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (5)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cardiac Arrest | — | UNRESOLVED | — |
| Cardiopulmonary Arrest | — | UNRESOLVED | — |
| Pediatric ALL | Childhood Acute Lymphoblastic Leukemia | ALIAS | 0.90 |
| Pediatric Emergency Medicine | — | UNRESOLVED | — |
| Resuscitation | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| bag-valve-mask ventilation | Device | — | UNRESOLVED |
| i-gel ® device | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Bag-valve-mask ventilation
- description
- Providers will perform a cardiopulmonary resuscitation, and deliver ventilations using a bag-valve-mask
- interventionNames
- Device: bag-valve-mask ventilation
- type
- EXPERIMENTAL
- label
- Supraglottic airway device ventilation
- description
- Providers will perform a cardiopulmonary resuscitation, and deliver ventilations using an i-gel® supraglottic airway device
- interventionNames
- Device: i-gel ® device
Primary outcomes (1)
- measure
- Alveolar ventilation per minute
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
Show eligibility criteria text
Inclusion Criteria: * Being a registered EMT, or paramedic Exclusion Criteria: * Member of the study team
References
Publications (1)
- DERIVEDStuby 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. PMID 40450752