Clinical trial NCT05498402: Effect of IAM With an I-gel® on Ventilation Parameters in Simulated Pediatric OHCA
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pediatric ALL
Cardiac Arrest
Cardiopulmonary Arrest
Resuscitation
Pediatric Emergency Medicine
Lead sponsor: Geneve TEAM Ambulances
Sponsor class: OTHER
Collaborators: name: ESAMB - College of Higher Education in Ambulance Care
name: Ambulances de la Ville de Sion
name: University Hospital, Geneva
First posted: 2022-08-12
Enrollment: 34
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Prospective, multicenter, crossover, simulation-based, randomized controlled trial
Primary purpose: TREATMENT

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.

Eligibility criteria: Inclusion Criteria:

* Being a registered EMT, or paramedic

Exclusion Criteria:

* Member of the study team

Primary outcomes:
measure: Alveolar ventilation per minute
timeFrame: 10 minutes of scenario
Secondary outcomes:
measure: The proportion, and number of ventilations below, within and over the target volume
timeFrame: 10 minutes of scenario
measure: The time to the first efficient ventilation
timeFrame: 10 minutes of scenario
measure: The time to the first compression
timeFrame: 10 minutes of scenario
measure: The chest compression fraction
timeFrame: 10 minutes of scenario
measure: The chest compression rate
timeFrame: 10 minutes of scenario
measure: The proportion of chest compressions below, within and over the target rate
timeFrame: 10 minutes of scenario
measure: The compression depth
timeFrame: 10 minutes of scenario
measure: The proportion of chest compressions below and within the target depth
timeFrame: 10 minutes of scenario
measure: The proportion of complete chest recoil
timeFrame: 10 minutes of scenario
measure: The time to first epinephrine injection
timeFrame: 10 minutes of scenario
measure: The proportion of scenarios in which epinephrine is administered within 5 minutes
timeFrame: 10 minutes of scenario
Other outcomes:
Locations:
city: Chêne-Bougeries
country: Switzerland
facility: ACE Genève Ambulances
state: Geneva
city: Sion
country: Switzerland
facility: Ambulances de la Ville de Sion
state: Valais
city: Geneva
country: Switzerland
facility: Genève TEAM Ambulances
city: Geneva
country: Switzerland
facility: SK Ambulances
Study officials:
affiliation: Genève TEAM Ambulances
name: Loric Stuby
role: PRINCIPAL_INVESTIGATOR
References: