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

NCT ID: NCT05498402

Last Updated: 2023-09-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 34 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-01-30
• Study Completion Date: 2023-06-13

Brief 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. 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.

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.

Conditions

Pediatric ALL; Cardiac Arrest; Cardiopulmonary Arrest; Resuscitation; Pediatric Emergency Medicine

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Bag-valve-mask ventilation

Providers will perform a cardiopulmonary resuscitation, and deliver ventilations using a bag-valve-mask

Group Type: ACTIVE_COMPARATOR

bag-valve-mask ventilation

Intervention Type: DEVICE

Ventilations will be delivered using a bag-valve-mask

Supraglottic airway device ventilation

Providers will perform a cardiopulmonary resuscitation, and deliver ventilations using an i-gel® supraglottic airway device

Group Type: EXPERIMENTAL

i-gel ® device

Intervention Type: DEVICE

Ventilations will be delivered through an i-gel ® device

Interventions

i-gel ® device

Ventilations will be delivered through an i-gel ® device

Intervention Type: DEVICE

bag-valve-mask ventilation

Ventilations will be delivered using a bag-valve-mask

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• Being a registered EMT, or paramedic

Exclusion Criteria

• Member of the study team

• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

ESAMB - College of Higher Education in Ambulance Care

UNKNOWN

Sponsor Role: collaborator

Ambulances de la Ville de Sion

UNKNOWN

Sponsor Role: collaborator

University Hospital, Geneva

OTHER

Sponsor Role: collaborator

Geneve TEAM Ambulances

OTHER

Sponsor Role: lead

Responsible Party

Stuby Loric

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Loric Stuby

Role: PRINCIPAL_INVESTIGATOR

Genève TEAM Ambulances

Locations

ACE Genève Ambulances

Chêne-Bougeries, Canton of Geneva, Switzerland

Ambulances de la Ville de Sion

Sion, Valais, Switzerland

Genève TEAM Ambulances

Geneva, , Switzerland

SK Ambulances

Geneva, , Switzerland

Countries

Switzerland

References

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.

Reference Type: DERIVED

PMID: 40450752 (View on PubMed)

Related Links

https://swiss-cpr-studies.ch/

Whole project website

Other Identifiers

CPR-6

Identifier Type: -

Identifier Source: org_study_id