TY - JOUR
T1 - Design of a novel clinical trial of prehospital pediatric airway management
AU - Bosson, Nichole
AU - Hansen, Matthew
AU - Gausche-Hill, Marianne
AU - Lewis, Roger J.
AU - Wendelberger, Barbara
AU - Shah, Manish I.
AU - VanBuren, John M.
AU - Wang, Henry E.
N1 - Publisher Copyright:
© The Author(s) 2021.
PY - 2022/2
Y1 - 2022/2
N2 - Emergency Medical Services personnel are often the first to intervene in the care of critically ill children. Airway management is a fundamental step in prehospital resuscitation, yet there is significant variation in current prehospital airway management practices. Our objective is to present a methodologic approach to determine the optimal strategy for prehospital pediatric airway management. We describe the conceptual premise for the Pediatric Prehospital Airway Resuscitation Trial, a novel Bayesian adaptive sequential platform trial. We developed an innovative design to enable comparison of the three predominant prehospital pediatric airway techniques (bag-mask-ventilation, supraglottic airway insertion, and endotracheal intubation) in three distinct disease groups (cardiac arrest, major trauma, and other respiratory failure). We used a Bayesian statistical approach to provide flexible modeling that can adapt based on prespecified rules according to accumulating trial data with patient enrollment continuing until stopping rules are met. The approach also allows the comparison of multiple interventions in sequence across the different disease states. This Bayesian hierarchical model will be the primary analysis method for the Pediatric Prehospital Airway Resuscitation Trial. The model integrates information across subgroups, a technique known as “borrowing” to generate accurate global and subgroup-specific estimates of treatment effects and enables comparisons of airway intervention arms within the overarching trial. We will use this Bayesian hierarchical linear model that adjusts for subgroup to estimate treatment effects within each subgroup. The model will predict a patient-centered score of 30-day intensive care unit-free survival using arm, subgroup, and emergency medical services agency as predictors. The novel approach of Pediatric Prehospital Airway Resuscitation Trial will provide a feasible method to determine the optimal strategy for prehospital pediatric airway management and may transform the design of future prehospital resuscitation trials.
AB - Emergency Medical Services personnel are often the first to intervene in the care of critically ill children. Airway management is a fundamental step in prehospital resuscitation, yet there is significant variation in current prehospital airway management practices. Our objective is to present a methodologic approach to determine the optimal strategy for prehospital pediatric airway management. We describe the conceptual premise for the Pediatric Prehospital Airway Resuscitation Trial, a novel Bayesian adaptive sequential platform trial. We developed an innovative design to enable comparison of the three predominant prehospital pediatric airway techniques (bag-mask-ventilation, supraglottic airway insertion, and endotracheal intubation) in three distinct disease groups (cardiac arrest, major trauma, and other respiratory failure). We used a Bayesian statistical approach to provide flexible modeling that can adapt based on prespecified rules according to accumulating trial data with patient enrollment continuing until stopping rules are met. The approach also allows the comparison of multiple interventions in sequence across the different disease states. This Bayesian hierarchical model will be the primary analysis method for the Pediatric Prehospital Airway Resuscitation Trial. The model integrates information across subgroups, a technique known as “borrowing” to generate accurate global and subgroup-specific estimates of treatment effects and enables comparisons of airway intervention arms within the overarching trial. We will use this Bayesian hierarchical linear model that adjusts for subgroup to estimate treatment effects within each subgroup. The model will predict a patient-centered score of 30-day intensive care unit-free survival using arm, subgroup, and emergency medical services agency as predictors. The novel approach of Pediatric Prehospital Airway Resuscitation Trial will provide a feasible method to determine the optimal strategy for prehospital pediatric airway management and may transform the design of future prehospital resuscitation trials.
KW - Emergency Medical Services
KW - airway management
KW - endotracheal intubation
KW - pediatrics
KW - supraglottic airways
UR - http://www.scopus.com/inward/record.url?scp=85121385315&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=85121385315&partnerID=8YFLogxK
U2 - 10.1177/17407745211059855
DO - 10.1177/17407745211059855
M3 - Article
C2 - 34875893
AN - SCOPUS:85121385315
SN - 1740-7745
VL - 19
SP - 62
EP - 70
JO - Clinical Trials
JF - Clinical Trials
IS - 1
ER -