Ventilation efficacy during Paediatric Cardiopulmonary Resuscitation (PEDIVENT): Simulation-based Comparative Study

doi:10.21203/rs.3.rs-2607404/v1

Background: To our knowledge, this is the first study concerning the effectiveness of 5 initial breaths and subsequent ventilation during paediatric resuscitation. The recommendations on initial resuscitation in unresponsive non-breathing children differ worldwide. Most cardiac arrests in children are secondary (hypoxic or asphyctic in origin) and ventilation during resuscitation is associated with better neurological outcomes. However, it is not clear whether the particular introduction sequence of paediatric resuscitation has any impact on the outcomes and if the effectiveness of ventilation could be improved by simulation based training.

Methods: The aim of this prospective simulation-based comparative study was to evaluate the ventilation efficacy during paediatric cardiopulmonary resuscitation (CPR) provided by health care professionals (HCP) and lay rescuers (LR). The primary outcome was the number of effective breaths during 5 initial CPR breaths. The secondary outcomes were: sub-analysis of 2 first ventilation attempts, time to first effective ventilation, time to 5 and 2 effective breaths, number and percentage of 5 initial breath attempts with ideal, low and high volume, and time to the chest compressions initiation. All parameters were measured before and after structured simulation based training. HCPs and LRs performed 90 seconds of CPR on 2 mannequins: 5 kg Baby and 20 kg Junior. The HCPs provided bag-mask ventilation; LR performed dispatcher-assisted CPR with mouth-to-mouth ventilation.

Results: Data were obtained from 40 HCPs and 46 LRs. Significant improvement in the number of effective ventilations before and after the training in Baby was in HCPs 26 (65%) vs. 40 (100%) and in LRs 28 (60.9%) vs. 45(97.8%), (both P˂0.001). In Junior the improvement was significant only in the LR group 32 (82.1%) vs. 37 LR (94.9%), P=0.005), but not in the HCPs group (31 HCPs before (77.5%) and 32 HCPs after structured training (82.1%), (P=0.77).

Conclusion: The structured training improved the number of effective ventilation during simulated paediatric CPR performed by health care professionals and lay rescuers.

Trial Registration: This study is registered at ClinicalTrials.gov (ID: NCT05345704)

Health sciences/Medical research/Outcomes research

Health sciences/Medical research/Paediatric research

Health sciences/Medical research/Pre clinical studies

paediatric

cardiopulmonary resuscitation

CPR

ventilation

efficacy

Ventilation is an integral part of paediatric resuscitation as recommended by European Resuscitation Council (ERC) because oxygen depletion is the most common cause of cardiac arrest in children. (1) The recommendation regarding the initial breaths during paediatric cardiopulmonary resuscitation (CPR) varies worldwide. (2) (3) The analysis of breath effectiveness could provide information, clarify and perhaps help to unify this discussed part of the resuscitation strategy. However, to our knowledge, no study to date has analysed the effectiveness and quality of initial rescue breaths during simulated or real cardiopulmonary resuscitation of children and infants. We used simulation as an investigation tool (4) in this cross-over prospective study evaluating ventilation efficiency during simulated paediatric CPR performed by 2 different groups of potential rescuers – physicians and nurses, representing the healthcare professionals (HCPs) performing Paediatric Basic Life Support (PBLS) with bag-mask ventilation, and lay rescuers (LRs) performing dispatcher-assisted PBLS with mouth-to-mouth ventilation. We hypothesised, that in HCPs more than 80% of ventilation attempts from 5 initial breaths will be effective (4 out of 5 breaths). In LRs, more than 60% of ventilation attempts (3 out of 5 breaths).

The primary outcome was the number of ventilations that are effective out of the first 5 attempts in each group before and after structured training.

After receiving the letter of acknowledgement from the Ethics Committee of the University Hospital Brno, this prospective, cross-over prospective study was performed at the Simulation Center of Masaryk University in Brno (SIMU) and the Department of Paediatric Anaesthesiology and Intensive Care Medicine, University Hospital Brno between April and July 2022. This study was registered at ClinicalTrials.gov (ID: NCT05345704) in April 2022.

The written informed consent was provided by participants, demographics were recorded: age, gender, role (physician/nurse/lay rescuer) and experience with real-life CPR (BLS/ALS/none). The participants were asked to perform a 90-second CPR on 2 different simulation mannequins: a 5 kg infant (Baby) and a 20 kg child (Junior). Figure 1 flowchart depicts the flowchart of data acquisition. The ERC guideline algorithm 2021 of Paediatric Life Support was considered the standard for resuscitation. (1)

The cases were presented and supervised by two certified EPALS (European Paediatric Advance Life Support) instructors.

The HCP was defined as a person, with the competence to perform the medical profession according to the valid legislation, in our case physicians or nurses.

HCPs were recruited from the tertiary university hospital paediatric department (non-ICU personnel) no further exclusion criteria were applied. HCPs are trained regularly once per year (in-hospital training) in CPR. The presented case was a non-breathing paediatric patient and the task was to perform 90-second high-quality CPR, starting with 5 initial breaths and continuing with chest compression to ventilation ratio of 15:2. Basic equipment was available (correct size mask and bag), with no other advanced equipment available immediately according to the presented scenario.

Lay rescuers were recruited on a volunteer basis after the random call for participation in the simulation-based study. Anyone who was not considered a health care professional was acknowledged as a lay rescuer. No further exclusion criteria were applied.

The resuscitation was led according to a standardized dispatcher-assisted CPR script (Figure 2), after EMS service activation for LRs. The information for the participant was that the paediatric patient was not breathing and the task was to perform 90 seconds of high-quality CPR, starting with 5 initial breaths and continuing with chest compression to ventilation ratio of 15:2, according to the dispatcher's guidance. The ratio of 15:2 for a dispatcher-assisted PBLS was chosen for better comparison of CRP-related measurements between the groups of HCPs and LRs. No specific equipment was available according to the presented scenario.

The infant mannequin was Laerdal Resusci Baby QCPR (Baby). The estimated weight of the simulated patient was declared to be 5 kg. The mannequin firmware version was 1.9.1.126.

The child mannequin was Laerdal Resusci Junior QCPR (Junior). The estimated weight of the simulated patient was declared to be 20 kg. The mannequin firmware version was 1.21.1.124.

Secondary outcomes included: sub-analysis of 2 first ventilation attempts, time to first effective ventilation, time to 2 and 5 effective breaths, number and percentage of the 5 initial breath attempts with ideal, low and high breath volume, and time to the beginning of chest compressions.

Sample sizes were determined by a power analysis (see statistical methods).

Measurements

Effective breath was defined as breath that caused visible chest rise. The effectiveness of ventilation was recognized by mannequin software and visually confirmed by trained independent observers. Both the mannequin record and observer record had to be in concordance to mark a ventilation attempt as effective. Volume and time of each breath, as well as the time of chest compressions initiation, were obtained from the mannequin software.

The time to the first effective breath was measured in HCPs from the moment the participant took the bag mask in hand. For the lay rescuers, the time was measured from the moment the dispatcher instructed the participant to give 5 initial breaths.

The ideal tidal volume was defined as between 30 and 50 mL for the Baby (6 to 10 mL per kg). It was low if less than 30 mL volume was delivered. It was high if more than 50 mL volume was delivered.

The ideal tidal volume was defined as between 120 and 200 mL for the Junior (6 to 10 mL per kg). It was low if less than 120 mL volume was delivered. It was high if more than 200 mL volume was delivered.

The data were collected before and after simulation-based CPR training.

The study was conducted in accordance with guidelines for simulation-based healthcare research. (4)

Statistical methods

The power analysis was based on the following prerequisites: A sample size of 40 achieves 80% power to detect a mean of paired differences of -0.8 with an estimated standard deviation of differences of 1.8 and with a significance level (alpha) of 0.05 using a two-sided paired t-test.

Standard descriptive statistics were applied in the analysis: absolute and relative frequencies for categorical variables and mean and median continuous variables. The intra-individual difference before and after training were tested using Wilcoxon Signed Ranks Test. The level of statistical significance used in all tests was α = 0.05. Statistical analysis was computed using SPSS 28.0.1.1 (IBM Corp., 2021, IBM SPSS Statistics for Windows, Version 28.0.0. 1, Armonk, NY, USA).

In total 86 participants were included in the analysis, of that 40 participants were HCPs and 46 were LRs. Characteristics of participants are displayed in Table 1.

Four effective breaths out of 5 initial breaths attempts (primary outcome for HCPs) in the Baby mannequin were delivered by 26 HCP (65%) before the training and 40 HCP (100%) after the training, indicating a significant improvement in the number of effective ventilation attempts delivered before and after the training (P˂0.001). In the Junior mannequin, the primary outcome was reached by 31 HCP (77.5%) and 32 HCP (82.1%), (P=0.77) before and after the training, respectively.

Three effective breaths out of 5 initial breaths attempts (primary outcome for LRs) in the Baby mannequin were delivered by 28 LRs (60.9%) before the training and 45 LRs (97.8%) after the training (P˂0.001). In the Junior mannequin, the primary outcome was achieved by 32 LRs (82.1%) before the training and 37 LR (94.9%) after the training (P=0.005).

In the Baby mannequin, the sub-analysis of the two first attempts revealed that in the HCP group 24 participants (60.0%) were able to deliver effective breaths with their 2 ventilation attempts before the training and 39 (97.5%) after the training (P < 0.001).

In the lay rescuer group, 23 participants (50.0%) were able to deliver 2 effective breaths with their first 2 ventilation attempts before the training and 44 (95.7%) after the training (P<0.001). Data from one LR participant were not valid.

In the Junior mannequin, the sub-analysis of 2 initial ventilation attempts, 28 HCPs (70.0%) were able to deliver 2 effective breaths within their first 2 ventilation attempts before the training, and 31 participants (79.5%) after the training (P=0.308).

In the LRs group, 27 participants (69.2%) were able to deliver 2 effective breaths with their first 2 ventilation attempts before the training and 38 (97.4%) after the training (P=0.02).

Overall effectivity during 5 initial ventilation attempts in Baby and Junior mannequins, before training and after training in both groups are summarized in Table 2.

The number and percentage of breaths with ideal, low and high volumes from 5 initial breaths are summarized in Figure 3a for Baby and Figure 3b for Junior mannequin.

In the Baby mannequin, the HCP group was able to deliver the first effective ventilation in a significantly shorter time than LRs before the training (P=0.03), but the difference was not significant after the training (P=0.43). The time needed to deliver 2 effective breaths was significantly shorter in the HCP group before (P= 0.003) the training. After the training, this difference was not significant (P= 0.10). The time needed to achieve 5 effective breaths was significantly shorter in the HCP group before and after the training (P= 0.017, P=0.002 respectively). The five effective breaths could have been achieved also after the compressions have been initiated.

In the Junior mannequin, the HCP group was able to deliver the first effective ventilation more quickly than LR (P= 0.003) before the training but not after the training (P=0.22). The time needed to deliver 2 effective breaths was shorter in HCP than in LR before the training, the difference was not statistically significant (P= 0.77). Conversely, lay rescuers needed a significantly shorter time to deliver 2 effective breaths after the training (P= 0.038). The time needed to achieve 5 effective breaths was not significantly different between the groups neither before (P= 0.16), nor after the training (P= 0.43).

The time to begin the chest compressions was significantly shorter in the HCP group in comparison to LRs in all measurements. In the Baby mannequin before (P˂0.001), and after the training (P˂0.001), in Junior before (P= 0.017) and after the training (P= 0.017).

See Table 3 for concrete time measurements at each group on Baby and Junior mannequins before and after structured CPR training.

To our knowledge, this is the first study investigating ventilation effectiveness in paediatric CPR. The data display the benefit of practical paediatric CPR training by improving the number of effective initial breaths in both HCPs and LRs. Using chest compressions with rescue breaths is associated with higher survival to discharge and survival with a good neurological outcome than either no CPR or chest compression-only CPR in paediatric patients. (5) Lay rescuers, if they are willing, trained and able to do so, should deliver rescue breaths to children in addition to chest compressions during CPR. (6) Providing effective ventilation breaths in paediatric CPR is a parameter of good quality CPR and has the potential to influence patient outcomes. (7,8) However; the data on the efficiency of ventilation during paediatric ALS and BLS are lacking.

The sequence of ventilations and compressions during paediatric CPR in ALS and BLS remains a topic of discussion. The systematic review conducted by the ILCOR (International Liaison Committee on Resuscitation) 2020 task force identify no difference in outcomes when comparing the sequence of paediatric CPR initiation in regard to Compressions-Airway-Breaths (CAB) as recommended in American Heart Association (AHA) guidelines versus Airway-Breaths-Compressions (ABC) as stated in ERC and ANZCOR (Australian and New Zeeland Committee on Resuscitation) guidelines. (9)

ERC guidelines recommendation to start ventilation with 5 initial breaths in paediatric CPR, was historically based on the experts´ opinion. (1) The reasoning for initial breaths was the possibility of reverting the hypoxia before the initiation of chest compressions. Another reason for introducing 5 initial breaths was the possibility to reverse respiratory arrest with bradycardia (with a pulse) before the cardiac arrest occurs. Other resuscitation guidelines worldwide do not include initial resuscitation breaths in lay rescuers. (2,3) However, ANZCOR 2021 guidelines recommend paediatric CPR 30:2 (LRs) or 15:2 (HCPs) ratio starting with 2 breaths before initiating the chest compressions. (3) The AHA guidelines do not make difference in sequence between adults and children and adopted CAB sequence with a 30:2 ratio for LRs and 15:2 for two or more HCPs. The reasoning for CAB is mainly uniformity and easier implementation as well as the shorter time to the chest compression initiation. The possible disadvantage of this approach is that the chest compressions will deliver almost no oxygen in the case of the secondary cardiac arrest victims until the breaths are started. The ERC approach seems to be more pathophysiology-driven for the children (and similarly e.g. in the drowning or avalanche victims) (10) but the differences from the standard adult algorithm might make it harder to implement the system in the wide community. As there is no strong evidence favouring either sequence it remains a controversial theme in the paediatric resuscitation community worldwide.

The 2 initial breath attempts were effective in approximately 55% of LRs and 60% of HCPs in the Baby mannequin. When 5 attempts of initial breaths were performed, at least 2 effective breaths were delivered in 77% of LRs and 90% of HCPs in the Baby mannequin before the structured training. In the Junior mannequin, 2 ventilation attempts led to effective breaths in approximately 70% of LRs and HCPs before the training. If 5 attempts were performed, at least 2 effective breaths were achieved in approx. 95 % of LRs and HCPs (see Table 2). This study indicates that the 5 initial breath attempts increase the probability that at least 2 ventilations will be effective. The data suggest that the training improves the percentage of breaths with correct volumes. This is potentially important as both hypoventilation and hyperventilation during CPR are associated with worse outcomes.

It is difficult to establish the efficacy of ventilation in real-life resuscitation. There is a lack of studies that would look not only at whether the ventilation was performed but also whether they were effective in the sense of chest rising or the tidal volume and frequency.

According to our data, LRs were able to improve in most of the parameters significantly from the baseline. There is a steep learning curve for participants without regular training in paediatric CPR, nevertheless retaining the skill through regular practice is advisable and may be a topic of our future research. The time to chest compressions can also be improved by training and 5 breaths can be delivered in a reasonably short time after training postponing the chest compressions by less than 15 seconds.

The study confirmed that LRs providing dispatcher-assisted CPR were able to deliver effective breaths in both the Baby and Junior mannequin. If LRs would deliver rescue breaths in real life, the breaths will likely be effective and the likelihood increases with more ventilation attempts (2 vs. 5 attempts). Thus performing 5 initial rescue breath attempts can lead to higher CPR quality and potentially better outcomes in real patients from the reasons specified above.

Simulation is now a widely used and well-established educational strategy in health care. It has also gained an important role as an investigation method in resuscitation-based research, allowing CPR quality checks and improvement. (11) Using a strategy of adult learning with a safe learning environment, both groups were given feedback in a form of a short debriefing of their performance. (12) Nevertheless, the study was performed on simulation mannequins, and thus the extrapolation in real life is not easy to assess and adds to the limitations of this study. Simulated CPR can mimic the real event only up to a certain degree. On the other hand, performing a similar study in real life would be highly challenging or impossible considering the overall low incidence of paediatric cardiac arrest and other possible impracticalities.

The majority of participants in both groups (HCP, LR) were women. This reflects accurately the situation in the European healthcare system, where women are more involved in healthcare professions (e.g. nurses, and paediatricians). (13)

The time to perform certain steps in the CPR algorithm in LRs before training was highly dependent on the communication with the EMS dispatcher. After the training, the LRs gained a framework of the CPR sequence, and thus probably reacted in a shorter time. The preservation of gained knowledge after a single structured training is questionable and may offer an opportunity for future research.

Due to technical difficulties with the Junior mannequin, we were unable to collect data from all LRs (Fig 1). The improvement in ventilation was more pronounced in the Baby mannequin. This may be due to initial general concerns of the rescuers not to harm the baby when performing CPR. With the training, the participants gained confidence and this could have attributed to improvement in ventilation parameters.

The structured simulation-based training improved the number of effective breaths during initial ventilation in paediatric CPR in health care professionals and lay rescuers in the Baby mannequin 26 HCP (65%) before and 40 HCP (100%) after the training (P˂0.001). In the Junior mannequin, the improvement was also recorded in both groups, but only in the lay rescuers' group, it was statistically significant (28 LRs (60.9%) before and 45 LRs (97.8%) after the training (P˂0.001). When 5 ventilation attempts were provided, instead of only 2 ventilation attempts, the likelihood of at least 2 effective breaths delivery increased in HCP and LR in both Baby and Junior mannequins.

More studies are needed to assess the effectiveness of initial breaths during paediatric CPR to make a worldwide consensus on this matter.

CPR- cardiopulmonary resuscitation

HCP- health-care professional

LR-lay rescuer

ERC-European Resuscitation Council

SIMU- Simulation Center of Masaryk University in Brno

ALS-Advanced Life Support

BLS- Basic Life Support

EPALS- European Paediatric Advance Life Support

AHA - American Heart Association

ANZCOR- Australian and New Zeeland Committee on Resuscitation

ILCOR- International Liaison Committee on Resuscitation

Ethics

The trial was initiated after the approval of the Ethics Committee of the University Hospital Brno, Jihlavska 20, 62500, Brno, Czech Republic (Project number 44/22; chairperson: Pharm. Dr Kozakova; date of approval: 16^th March 2022) and after the registration on clinicaltrials.gov (NCT05345704, Registered 26^th April 2022). The written informed consent for participation in simulation studies was obtained from all participants and can be accessed upon request made to the corresponding author or first author. Informed consent was written with accordance with the standards for participation in the simulation studies. No humans or human tissues were otherwise used in the study.

The authors declare that they have no competing interests.

Funding: This research was supported by the Specific University Research, provided by MŠMT (MUNI/A/1105/2022 and MUNI/A/1109/2022) and supported by MH CZ—DRO (FNBr, 65269705).

Availability of data and materials: All original data and materials used in this study can be accessed upon request made to the corresponding author or first author.

Authors' contributions

TS: Methodology, Data collection, Writing the original draft, Re- writing, Editing

MK: Conceptualization, Methodology, Writing the original draft, Editing, Re-writing

JD: Conceptualization, Methodology, Writing original draft, Re- writing, Editing

PJ: Conceptualization, Methodology, Data collection, Editing

TK: Conceptualization, Methodology, Data collection

JK: Methodology, Editing

VA: Data collection, Writing

PŠ: Conceptualization, Methodology, Editing, Supervision

All authors read and approved the final manuscript

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Table 1 – Participants´ Characteristics

Characteristics	LR (n= 46)	HCP (n=40)
Woman	35 (76.1%)	35 (87.5%)
Age (mean, SD)	16.8 (1.0)	41.3 (11.5)
Physicians	Not applicable	19 (47.5%)
Nurses	Not applicable	21 (52.5%)
CPR in real life
ALS	Not applicable	23 (57.5%)
BLS	2 (4.3%)	0
Data not provided	0	1 (2.5%)

n=number of participants, SD= standard deviation, CPR= Cardiopulmonary Resuscitation, ALS= Advanced-life Support, BLS=Basic-life Support, LR= Lay Rescuer group, Health-care Professionals

Table 2 Number of participants delivering 0 to 5 effective breaths out of the first 5 ventilation attempts

Participant group	N	0	1	2	3	4	5
LR Baby BT	46	16 (34.8%)	1 (2.2%)	1 (2.2%)	3 (6.5%)	5 (10.9%)	20 (43.5%)
LR Baby AT	46	1 (2.2%)	0	0	0	0	45 (97.8%)
LR Junior BT	39	2 (5.1%)	2 (5.1%)	3(7.7%)	3 (7.7%)	6 (15.4%)	23 (59.0%)
LR Junior AT	39	0	0	1 (2.6)	0	3 (7.7)	34 (87.2%)
HCP Baby BT	40	4 (10.0%)	5 (12.5%)	1 (2.5%)	4 (10.0%)	4 (10.0%)	22 (55.0%)
HCP Baby AT	40	0	1 (2.5%)	0	0	0	39 (97.5%)
HCP Junior BT	39	2 (5.0%)	1 (2.5%)	1 (2.5%)	5 (12.5%)	4 (10.0%)	27 (67.5%)
HCP Junior AT	39	1 (2.6%)	2 (5.1%)	2 (5.1%)	2 (5.1%)	3 (7.7%)	29 (74.4%)

Participant group (Lay Rescuer=LR/ Health Care Professional=HCP), type of mannequin (Baby/Junior), Before Training (BT)/ After Training (AT), N = number of participants delivering 0-5 effective breaths out of first 5 ventilation attempts, percentage

Table 3 Time measurements (Time to deliver first effective breath, 2 effective breaths, 5 effective breaths and beginning of chest compressions)

Participant group	Time to deliver first effective breath (s) mean, [SD]	Time to 2 effective breaths (s) mean, [SD]	Time to 5 effective breaths (s) mean, [SD]	Time to beginning of chest compression (s) mean, [SD]
LR Baby BT	14.7 [22.2]	16.5 [22.0]	26.0 [24.0]	26.6 [8.0]
LR Baby AT	1.7 [1.4]	4.5 [4.9]	11.0 [7.5]	12.6 [4.1]
LR Junior BT	4.5 [8.4]	8.6 [13.6]	23.0 [18.6]	14.9 [3.8]
LR Junior AT	2.3 [2.7]	4.4 [3.1]	14.8 [10.0]	26.0 [24.0]
HCP Baby BT	4.5 [7.7]	7.6 [12.0]	17.0 [18.0]	13.3 [8.4]
HCP Baby AT	2.3 [ 2.0]	3.8 [2.6]	8.4 [4.9]	14.8 [3.8]
HCP Junior BT	3.7 [3.2]	6.6 [5.6]	16.3 [14.1]	12.2 [6.4]
HCP Junior AT	6.1 [13.6]	8.7 [14.6]	15.6 [15.2]	17.0 [18.0]

Participant group (Lay Rescuer=LR/ Health Care Professional=HCP), type of mannequin (Baby/Junior), Before Training (BT)/ After Training (AT), SD= standard deviation, s= seconds

No competing interests reported.

Ventilation efficacy during Paediatric Cardiopulmonary Resuscitation (PEDIVENT): Simulation-based Comparative Study

Status:

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Abstract

Figures

Background

Methods

Results

Discussion

Conclusion

Abbreviations

Declarations

References

Tables

Additional Declarations

Status:

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