Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT05498402 |
| Other study ID # |
CPR-6 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
January 30, 2023 |
| Est. completion date |
June 13, 2023 |
Study information
| Verified date |
September 2023 |
| Source |
Geneve TEAM Ambulances |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical 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. 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.
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.
