The Impact of Soiled Airway Management on CPR Quality
Phase: NA
Conditions: Airway Aspiration, Cardiopulmonary Arrest
Sponsor: Shin Kong Wu Ho-Su Memorial Hospital

Protocol Version/Date：Version 1，2018/5/16   Protocol No./IRB No.20180503R 
 
Clinical Trial Protocol Synopsis 
 
Protocol title： 
The impact of soiled airway management on CPR quality 
Objectives： 
To evaluate the influence of soiled airway management on the quality of CPR 
Background： 
Regurgitation is an adverse event common during cardiopulmonary resuscitation (CPR) and occurs 
in 20%-32% of patients experiencing out-of-hospital cardiac arrest (OHCA). It can impair 
ventilation, induce aspiration, and decrease survival to hospital discharge. Gastric fluid in the airway 
obscures the laryngeal view, thereby considerably decreasing the first-pass success of endotracheal 
intubation (ETI) by paramedics. 
A human cadaver study reported that ETI outperforms other airway management devices, such as 
the i-gel, laryngeal mask, and laryngeal tube, in preventing aspiration when regurgitation occurs 
during CPR. However, ETI is also associated with multiple and prolonged CPR pauses.Compared 
with the use of supraglottic airway (SGA) devices, ETI results in more hands-off time during CPR. 
Recent randomised clinical trials have revealed that airway management with an SGA device 
provides superior outcomes to those of ETI in patients with OHCA. However, ETI remains the 
preferred management strategy for an airway affected by regurgitation in patients with OHCA. 
Current guidelines focus on the quality of CPR because it is a key determinant of survival in patients 
with OHCA. However, evidence regarding the impact of regurgitation during ETI on CPR quality is 
limited. This manikin simulation study assessed CPR quality during ETI in airways with and without 
regurgitation. 
Study Design： 
A prospective compare study 
Methods： 
 This is a prospective compare study. 54 EMT-Ps, are involved to evaluate the impact of 
airway management on CPR quality. 
 
The Study uses SALAD training tool for training. The SALAD training tool include Nasco 
Intubation CPR manikin, which could vomit by pumping liquid into distal esophagus, and 
HQCPR feedback machine. Two scenarios were simulated. CPR and ETI in an airway with 
regurgitation (oropharyngeal regurgitation scenario) and CPR and ETI in an airway without 
regurgitation (clean airway scenario). All EMT-Ps were assigned to participate initially in 
one of the scenarios. After all EMT-Ps had finished the first scenario, they switched to the 
other. Three EMT-Ps formed a resuscitation team and played one of the following roles: 
airway manager, first compressor, or second compressor. In each scenario, each EMT-P was 
required to take a turn playing all three roles. During each simulation, the airway manager 
performed BVM ventilation, and the first and second compressors alternately provided chest 
compression for every five cycles of CPR, with a compression-to-ventilation ratio of 30:2. 
 
After the first five cycles of CPR, the airway manager was asked to perform intubation during 

Protocol Version/Date：Version 1，2018/5/16   Protocol No./IRB No.20180503R 
 
the ongoing chest compression to minimise intubation-associated interruption of chest 
compression. If necessary, the airway manager could request a pause of the ongoing chest 
compression. If intubation was not successful, the airway manager performed BVM 
ventilation twice and then reattempt intubation. After intubation, the airway manager used 
the BVM to check the lung distention to confirm successful intubation. Each simulation was 
ended after successful or failed intubation. Failed intubation was defined as either 
oesophageal intubation or three unsuccessful attempts. 
 
The primary outcomes were CPR quality metrics, namely chest compression fraction (CCF), 
chest compression depth, chest compression rate, and longest interruption time. The 
secondary outcomes were the intubation success rate and intubation time. 
 
Each CPR-intubation sequence comprised two segments: a compression segment and a 
hands-off segment. Presents the rules for determining the start and end of a CPR-intubation 
sequence. CCF was defined as the proportion of time spent on chest compression in each 
CPR-intubation sequence. The longest interruption time was defined as the longest hands-off 
duration in each sequence. An intubation attempt was defined as the insertion of the 
laryngoscope blade into the mouth and its subsequent withdrawal from the mouth. Intubation 
time was defined as the period between the start and the end of an intubation attempt. The 
time spent checking the endotracheal tube position by manual ventilation through the 
endotracheal tube was not included in the CPR-intubation sequence. 
 
Two video cameras were setup to record the entire simulation process. Two observers 
reviewed the video records independently to identify the start and end of each CPR-
intubation sequence, any intubation attempts, and the hands-off and compression segments 
of each sequence. Disagreements were resolved by reaching mutual consensus. The HQCPR 
application on an Android device recorded chest compression depth, rate, and interruptions 
(defined as no chest compression [hands off] for >1 s). The data from both the video 
recording and the HQCPR application were used in subsequent analysis.Continuous data are 
presented as medians with interquartile ranges, and categorical data are presented as 
frequency counts and percentages. The continuous data were compared using the Wilcoxon 
rank sum test in the first CPR-intubation sequence and the Mann-Whitney U test in the 
second and third sequences. The McNemar test was used to compare the intubation success 
rate in the first sequence, and Pearson's chi-square test was used for the second and third 
sequences. The continuous data from all three CPR-intubation sequences were compared 
using the Kruskal-Wallis test. Post hoc analysis was performed using Conover's test. 
 
The association of CPR quality metrics with successful intubation was evaluated using a Cox 
proportional hazards regression model. The results of multivariate analyses are presented as 
hazard ratios (HRs) with corresponding 95% confidence intervals (CIs). A two-tailed P <0.05 
indicates statistical significance. MedCalc Statistical Software version 19.2. (MedCalc 
Software, Ostend, Belgium) was used for data analysis. 
   
Effect： 
understand the impact of airway vomitus on CPR quality and intubation quality  

Protocol Version/Date：Version 1，2018/5/16   Protocol No./IRB No.20180503R 
 
Key words： 
Cardiopulmonary resuscitation, Airway decontamination, suction assisted, vomiting 
simulation