A cardiopulmonary resuscitation assist device improves pediatric resuscitation algorithm adherence: a randomized controlled trial

doi:10.21203/rs.3.rs-3108123/v1

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A cardiopulmonary resuscitation assist device improves pediatric resuscitation algorithm adherence: a randomized controlled trial

https://doi.org/10.21203/rs.3.rs-3108123/v1

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Background: Most widely used cardiopulmonary resuscitation (CPR) assist devices only focus on chest compression (CC), without accounting for CPR algorithms. Therefore, we aimed to evaluate the efficacy of a novel CPR assist device (XXX-CPR Helper) in improving resuscitation algorithm adherence in simulated pediatric cardiac arrest.

Methods: A single blind randomized controlled trial was conducted using a pediatric simulation-based method among 30 resuscitation teams (113 medical students). The teams were randomized into an intervention or control group. The intervention group used the new CPR Helper during the simulation. All events and measurements were recorded using the SimView™ program. Adherence to the standard pediatric CPR algorithm was assessed using four criteria: average CC rate of 100–120/min, 2-min CC and pulse check cycle, first defibrillation given within 1 min, and administration of first adrenaline dose within 3 min after CC initiation. This trial is registered with Thaiclinicaltrials.org, TCTR20230717001.(registered on 17 July 2023)

Results: The percentage of teams achieving all four criteria was significantly higher in the intervention than in the control group (28.6% versus 0%, p= 0.042). The percentage of teams with a CC rate of 100–120/min was significantly higher in the intervention group (93.3% versus 40%, p= 0.005). However, there was no significant difference in the average CC rate between the groups (109 versus 105, p= 0.203).

Conclusion: The XXX-CPR Helper is an effective CPR assist device, as it can improve adherence to the CPR algorithm, especially among inexperienced resuscitators.

cardiopulmonary resuscitation

algorithm adherence

feedback device

simulation

pediatric

Pediatric in-hospital cardiac arrest (IHCA) has a high mortality rate and remains a major health concern. Despite the provision of cardiopulmonary resuscitation (CPR) by medical personnel with full access to equipment, more than half of pediatric IHCA patients do not survive [1, 2]. High-quality chest compression (CC) and effective airway management are the keys to pediatric resuscitation [3]. Indeed, several previous studies have reported a significant association between deviations from the resuscitation algorithm and poor IHCA outcomes [4–6].

According to the updated pediatric resuscitation algorithm [7], in cases of shockable pulseless cardiac arrest, resuscitators should focus on providing timely defibrillation. Provision of high-quality CC is essential, with timely adrenaline administration every 3–5 min. Adherence to this algorithm requires a well-organized resuscitation team including a team leader, chest compressor, timer, and medication administrator. Previous CPR assist devices could improve CPR performance [8–11]. Nevertheless, most were audio-visual feedback devices aimed at CC quality improvement but not at algorithm adherence. CPR assist devices targeting improvements in algorithm adherence usually involve the integration of CPR guidance software with manual defibrillation [12]. However, such commercial software is often unavailable in clinical practice worldwide, as well as unaffordable, particularly in developing countries. Therefore, we developed a novel CPR assist device (referred to as the XXX-CPR Helper)

We examined the ability of this device to improve resuscitation algorithm adherence among inexperienced medical students when treating a simulated pediatric cardiac arrest.

Study design and participants

A single-blind randomized trial was conducted at a university clinical training center in July–October 2020 The study had received ethical approval from Faculty of Medicine, Prince of Songkla University (REC-63-044-1-1, approved on 21 February 2020) and had performed in accordance with the Declaration of Helsinki. Eligibility screening was performed among 5th -year and 6th -year medical students. The students were eligible if they could participate in the simulation on the specified date. Participants were excluded if they had physical limitations affecting chest compression performance. Informed consent was obtained from all participants. They were then assigned to a four-member team by registration order. All teams were randomly allocated into the intervention (use the XXX-CPR Helper) or control group in a 1:1 ratio by computer-generated blocked randomization. The team assignment and random sequence for group allocation were concealed in an e-mail sent to a research assistant who was not involved in outcome assessments.

Device used

We used a prototype for a novel CPR assist device (referred to as the XXX-CPR Helper) developed and created by the Med PSU Innovation unit. The XXX-CPR Helper provided three functions: a metronome that was set at 100 bpm, a stopwatch for recording CPR duration, and voice alarms for pulse checks (2-min cycles) and adrenaline administration (3-min cycles). Both alarms could be reset by pressing a start/shock button (defibrillation button) (Fig. 1A). The device was designed to be placed and transported on a resuscitation or emergency trolley (Fig. 1B) and had dimensions of 16.5 cm (width)×20.5 mm (height)×7 cm (depth). The volume of the speaker was set at 100 dB to be discernable over background noise in a real-world CPR setting.

When the resuscitators initiated CPR and pressed the shock/start button (defibrillation button), the timer counted down from 2 min, and a voice prompt (“2 min, check pulse”) was provided after each 2-min CC cycle completion. Another timer simultaneously counted down from 3 min, and the voice prompt provided at the end of each 3-min cycle for adrenaline administration was “3 min, give adrenaline” (Fig. 2). The voice audio clip used for the alarm was recorded by a native English speaker. The accuracy of the metronome and time interval settings for each voice alarm were calibrated and checked in the innovation-unit laboratory.

Study protocol

On the CPR simulation day, all registered participants attended a 1 h lecture by a certified American Heart Association Pediatric Advanced Life Support (PALS) instructor, who reviewed the core knowledge of pediatric resuscitation (in accordance with the 2020 PALS guideline). The teams sequentially entered a simulation room. The simulation-based resuscitator team generally required at least four individuals. If a team lost a member for any reason, this individual was substituted by a simulation assistant who was not involved in outcome assessment for assisted ventilation during CPR simulation. A team that lost more than one member was excluded. Before beginning the simulation, instructions on the use of the entire resuscitation equipment in the simulation room were provided. A demonstration of XXX-CPR Helper use was only provided to participants in the intervention group. Participants in the control group were allowed to keep track of time via other means (e.g., digital watch, analog watch, or clock application on a smartphone) during the simulation.

The same pediatric cardiac arrest scenario, set on the SimMan 3G Laerdal® manikin, was used in both groups (Fig. 1C). This scenario required resuscitators to perform three CPR cycles (Fig. 2); these were initiated with pulseless ventricular fibrillation, followed by immediate defibrillation and a subsequent cycle of high-quality CC. At the end of the first CPR cycle, the cardiac rhythm progressed to pulseless electrical activity, which required another two cycles of CC and a dose of adrenaline before returning to spontaneous circulation. The information was transferred wirelessly from the manikin to a backup computer. All events and measurements during the simulation were recorded and collected directly by the Laerdal Learning Application (LLEAP)™ simulation software program

Endpoints and data collection

Data concerning age, sex, weight, height, and previous resuscitation experience were collected. Events during the simulation were processed and reported by LLEAP™. CC performance was evaluated using the average CC rate (bpm), depth (mm), and percentage of full recoil. CC pause time was defined as the amount of time without CC, and the CC fraction was defined as the ratio of time with CC to the total CPR duration. The CPR cycle time was the interval between the current rhythm analysis and the previous rhythm analysis and/or defibrillation.

The primary outcome was the percentage of teams that adhered to the CPR algorithm, defined by the following four criteria:

1) Average CC rate of 100–120/min in each simulation

2) First defibrillation within 1 min after a shockable rhythm was identified

3) First adrenaline dose administered within 3 min after CC initiation

4) CC cycle time of approximately 2 min (120 s).

The resuscitator teams were considered to have exhibited good adherence to the PALS algorithm if at least three of four adherence criteria were met. Secondary outcomes included the quality of CC throughout the simulation, average CC rate (bpm), percentage of a proper CC rate (defined as a CC rate of 100–120/min) [7], average CC depth (mm), percentage of proper CC depth (defined as > 50 mm),⁷ percentage of full CC recoil, CC fraction (percentage), and time of first adrenaline dose administration after defibrillation.

Statistical analysis

The sample size was determined based on a formula for the evaluation of binary data from randomized controlled studies and the predefined outcome (percentage of adherence to the PALS algorithm). Assuming that XXX-CPR Helper use would increase the adherence percentage to 90%, compared with 50% in the control group, at least 34 teams (17 teams for each group) were required; this number increased by 10% (38 teams) to account for dropouts (α = 0.05, 80% power). As the simulation-based resuscitator team generally required at least four individuals, 152 participants were required. Data were analyzed using STATA version R 4.0.2 (College Station, TX, USA). Continuous variables are presented as means and standard deviations (or medians and interquartile ranges), while categorical variables are presented as frequencies and percentages. The independent samples-t test was used for continuous outcomes, and Pearson’s chi-squared, or Fisher’s exact test was applied for categorical outcomes, as appropriate. Statistical significance was set at p < 0.05.

In total, 272 medical students were screened for eligibility. 120 who met eligible criteria were assign to 30 four-membered CPR teams. The eligible teams were randomized and allocated into the intervention (N = 15) and control groups (N = 15) (Figure 3). On the simulation day, there were seven participants missing resulting in seven three-membered teams. The number of three-membered teams was not significantly different between the intervention and control groups (3/15 versus 4/15, respectively; p = 0.67).

The intervention and control groups comprised 57 and 56 participants, respectively (15 teams each). Fifty-two (46.0%) were male and the median body mass index (BMI) was 21 (interquartile range, 19.2–23.8) kg/m². There were no significant differences in age, BMI, previous CPR training and experience, or pre-test scores in PALS basic knowledge between groups (Table 1). The proportion of 5^th-year medical students was significantly lower in the intervention than in the control group (66.6% versus 89.2%; p = 0.002).

Table 1. Baseline characteristics of participants (N = 113)

Characteristics	Intervention group N = 57 (%)	Control group N = 56 (%)	p-value
Age (years), median (IQR)	23.4 (22.9, 23.9)	23 (22.8, 23.7)	0.151
Body mass index (kg/m²) median (IQR)	21 (19.0, 22.2)	21 (19.2, 23.8)	0.274
5^th year medical students	37 (64.3)	50 (89.2)	0.002
Formal CPR training >6 months	37 (64.3)	31 (55.3)	0.300
No CPR experience	38 (66.0)	35 (62.5)	0.643
CPR knowledge (full score of 20), mean (SD)	13.2 (3.1)	12.3 (2.5)	0.088

CPR, cardiopulmonary resuscitation; IQR, interquartile range; SD, standard deviation

Primary outcome

The percentage of teams adhering to each PALS algorithm criterion is shown in Table 2. The overall adherence to the PALS algorithm was greater in the intervention. The percentage of teams satisfying three of four criteria was significantly greater in the intervention group than in the control group (64.3% versus 13.3%, p = 0.015); the percentage of teams meeting all four criteria was also significantly higher in the intervention group (28.6% versus 0%, p = 0.042). The percentage of teams with an average CC rate of 100–120 bpm was significantly higher in the intervention than in the control group (93.3% versus 40%, p = 0.005). However, there was no significant difference in the average CC rate between the groups (109 versus 105 bpm, p = 0.203). The percentage of teams with a CC cycle time of 2 min was significantly higher in the intervention than in the control group (93.3% versus 46.7%, p = 0.014). There was no significant difference in the percentage of teams that could administer the first defibrillation within 1 min or the first adrenaline dose for non-shockable rhythm within 3 min after CPR initiation (Table 2).

Table 2. Comparison of algorithm adherence between the groups (N = 30)

Adherence criteria	Intervention N = 15 (%)	Control N = 15 (%)	p-value
Average CC rate 100–120 bpm	14 (93.3%)	6 (40.0%)	0.005
First defibrillation within 1 min	10 (66.7%)	7 (46.7%)	0.461
First adrenaline dose given within 3 min	4 (26.7%)	3 (20%)	1.000
CC cycle time of approximately 2 min	14 (93.3%)	7 (46.7%)	0.014
Good adherence to CPR algorithm*	9 (64.3%)	2 (13.3%)	0.015

*defined as meeting at least three of four adherence criteria

CC, chest compression; CPR, cardiopulmonary resuscitation

Secondary outcomes

Regarding CPR quality, the proper CC rate (100–120 bpm) percentage was greater in the intervention than in the control group (87.1% versus 43.5%, p <0.001). The proper CC depth percentage was not significantly different between the groups (57.1% versus 60.0%, p = 0.684). There were no significant differences in the average CC rate, depth, fraction percentage, and full recoil percentage between the groups (Table 3). The first dose of adrenaline for non-shockable rhythm was administered more rapidly in the intervention group; however, this did not reach statistical significance (161.2 versus 185.5 s, p = 0.435).

Table 3. Comparison of CPR quality between the groups (N = 30)

CPR quality	Intervention (N = 15) mean + SD	Control (N = 15) mean + SD	p-value
Average CC rate (bpm)	109.0 (6.6)	105.0 (9.9)	0.203
Percentage of proper CC rate	87.1 (15.5)	43.5 (26.3)	<0.001
Average CC depth (mm)	31.6 (4.3)	30.9 (3.9)	0.681
Percentage of proper CC depth	57.1 (14.5)	60.0 (23.2)	0.684
Percentage of full CC recoil, median (IQR)	74.5 (42.2, 86.5)	96 (78.5, 97.0)	0.097
CC fraction (percentage)	74.3 (7.2)	73.7 (7.2)	0.819
First adrenaline dose given after defibrillation (s)	161.2 (61.4)	185.5 (101.6)	0.435

CC, chest compression; CPR, cardiopulmonary resuscitation; IQR, interquartile range

This study demonstrated that the XXX-CPR Helper could improve adherence to the CPR algorithm during the management of simulated pediatric cardiac arrest by medical students who were unfamiliar with the PALS criteria. Improvements in algorithm adherence were reflected by better control of the CC rate in an appropriate range (100–120 bpm) and more accurate 2-min cycling of rhythm and pulse checks, compared with that in traditional cardiopulmonary simulation training.

The criteria for good adherence to the PALS algorithm were based on the core concepts of resuscitation for pulseless cardiac arrest, which emphasize early defibrillation for shockable rhythm; early adrenaline administration; 3-min cycling for non-shockable rhythm; and 2 min of uninterrupted, high-quality CC [3,7]. While high-quality CC consists of an appropriate rate and depth of compression, as well as full chest recoil, we only focused on the CC rate in our adherence criteria, as this was the primary target of the XXX-CPR Helper.

Unlike other CPR assist devices, the XXX-CPR Helper facilitates the appropriate sequence of actions required of a CPR team. According to the PALS algorithm, a first responder must determine whether rhythms are shockable or non-shockable immediately following cardiac arrest. The first responder must then rapidly assign other team members to perform tasks such as keeping track of time for the 2-min pulse check and 3-min adrenaline administration cycles. These initial steps in CPR are often difficult and stressful, particularly for inexperienced first responders and medical personnel. Furthermore, previous studies have shown that resuscitation skills deteriorate in most medical personnel (e.g., medical and nursing students) over time [13,14], being most evident after 6 months following training completion [13]. Other personal characteristics (e.g., leadership ability, personality, and sex) also have a large impact on CPR algorithm adherence and team dynamics [15,16]. Novel CPR assist devices can regulate the flow of required actions via short and simple voice signals; such prompts pose a smaller risk of inducing greater stress among responders than do other forms of CPR feedback requiring visual attention [17].

The XXX-CPR Helper could ensure CC quality via a metronome that was set at 100 beats/min. Indeed, resuscitation teams using this device in the present study exhibited significantly better control of the CC rate than those in the control group. Nevertheless, the teams in both groups showed an average CC depth of <5 cm, which was too shallow, throughout the CPR session. Maintenance of an accurate CC depth requires skill and experience more than physical strength [18]. While the use of a real-time audio-visual CPR feedback system was reported to improve CPR performance [11], such devices have been associated with visual distraction and a greater workload for the resuscitation team [17].

The XXX-CPR Helper has an alarm to prompt adrenaline administration in a 3-min cycle. Here, there was no significant difference between groups in the percentage of teams that administered the first dose of adrenaline within an acceptable time range. Notably, the first dose of adrenaline for a non-shockable rhythm was administered earlier by teams in the intervention group than by teams in the control group. The appropriate administration of adrenaline is one of the most important factors for survival after CPR. Delay in administering the first dose of adrenaline in cases of non-shockable cardiac arrest has been associated with a lower survival rate [5]. A recent study reported that the administration of adrenaline over intervals of <2 min resulted in better outcomes than did administration over longer intervals in pediatric inpatients with cardiac arrest [19]. Therefore, our device only has a default setting for an adrenaline administration alarm every 3 min, without options for alarms at 4 or 5 min to prevent delays in adrenaline administration in real-world CPR situations.

Our study had several strengths. First, the outcome assessments were highly accurate since we used the simulation debriefing system (LLEAP^TM) to define the endpoints. Second, the participants were representative of inexperienced medical personnel (e.g., general practitioners or internists), who are often the first responders or team leaders in cases of in-hospital pediatric cardiac arrest in many hospitals. While most such workers have some clinical experience in pediatric care, few may have previously performed pediatric resuscitation. Therefore, inexperienced medical personnel are particularly likely to benefit from XXX-CPR Helper use.

Limitations

This study has some limitations. First, the sample size was smaller than desired based on the sample size calculation. Nevertheless, we achieved interesting and significant results. Second, the study was based on a simulation in the context of resuscitation training. Although repeated CPR simulations under standardized conditions for all participants are generally accepted for investigations using CPR assist devices, a definitive conclusion cannot be drawn regarding the effectiveness of the device without testing it in a real-world setting. Moreover, the lack of background noise that is usually present in real-world scenarios may have resulted in more favorable outcomes for the CPR assist device used.

Our findings demonstrated the efficacy of a novel CPR assist device (XXX-CPR Helper) in improving adherence to the pediatric CPR algorithm. Inexperienced resuscitators who used this device could better control their CC rate and perform 2-min pulse check cycles in simulated cases of pediatric cardiac arrest than did those who underwent traditional training. The XXX-CPR Helper is simple and affordable, and its use should be advocated for pediatric cardiac arrest, especially among inexperienced first responders.

CC: chest compression; CPR: cardiopulmonary resuscitation; IHCA: in-hospital cardiac arrest; PALS: Pediatric Advanced Life Support.

Ethical Approval: Ethics committee approval from Faculty of Medicine, Prince of Songkla University (REC-63-044-1-1, approved on 21 February 2020) was obtained prior to study initiation.

Consent to Participate: Written informed consent was obtained from all participants.

Consent for publication: Not applicable

Availability of data and materials: The dataset supporting the conclusions of this article are keep in “CPR-helper PED sim project” repository in our institute. This data are available on reasonable request from the corresponding author. The data are not publicly available due to privacy and ethical restrictions.

Competing interests: The authors declare that they have no competing interests

Funding: Data collection (facilitated the simulation) was supported by the Faculty of Medicine, Prince of Songkla University [grant number REC 63-044-1-1]. The sponsor had no involvement in the study design, analysis, and interpretation of data and in the decision to submit the article for publication.

Author Contributions:

KR: Conceptualization (lead), Methodology (equal), Investigation (equal), Formal analysis (equal), Writing- original draft (equal), Visualization (equal)

JP: Methodology(equal), Investigation (equal), Formal analysis (equal), Writing- original draft (equal), Visualization (equal)

PaP: Methodology (equal), Investigation (equal), Formal analysis (equal), Writing- original draft (equal), Visualization (equal)

KS: Resources (lead), Conceptualization (supporting), Methodology (equal), Investigation (equal), Writing- review& editing (supporting), Visualization (supporting)

PhP: Conceptualization (supporting), Methodology (equal), Investigation (equal), Writing- review& editing (supporting), Visualization (supporting)

WA: Conceptualization (supporting), Methodology (supporting), Resource (supporting) Writing- review& editing (supporting), Visualization (supporting)

Acknowledgements: We would like to thank the Prince of Songkla University Clinical Training Center, School of Medicine, Prince of Songkla University, for arranging the pediatric cardiac simulation in this study.

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No competing interests reported.

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A cardiopulmonary resuscitation assist device improves pediatric resuscitation algorithm adherence: a randomized controlled trial

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