Evaluation of Abdominal Compression-Decompression Combined With Chest Compression CPR Performed by a New Device: Is the Prognosis Improved After This Combination CPR Technique?

doi:10.21203/rs.3.rs-1298949/v1

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Evaluation of Abdominal Compression-Decompression Combined With Chest Compression CPR Performed by a New Device: Is the Prognosis Improved After This Combination CPR Technique?

https://doi.org/10.21203/rs.3.rs-1298949/v1

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Introduction: This study was designed to compare outcomes between standard cardiopulmonary resuscitation (STD-CPR) and combined chest compression and abdominal compression-decompression cardiopulmonary resuscitation (CO-CPR) with a new device following out-of-hospital cardiac arrest. Moreover, we investigated whether patient prognosis improved with this combination treatment.

Methods: This trial was a single-center, prospective, randomized trial with a blinded assessment of the outcome. A total of 297 consecutive patients with OHCA were initially screened, and 278 were randomized to STD-CPR (n=135) or CO-CPR (n=143). We compared return of spontaneous circulation (ROSC) rates, survival to hospital admission rates, survival to hospital discharge rates, and neurological outcomes at hospital discharge between the two groups. In addition, we also performed the Kaplan-Meier analysis at the end of the follow-up.

Results: An ROSC rate of 31/135 (22.96%) versus 35/143 (24.48%), and survival to a hospital admission rate of 28/135 (20.74%) versus 33/143 (23.07%) were found between in the CO-CPR group and the STD-CPR group respectively. The difference did not reach statistical significance. However, there was a significant difference in the survival to hospital discharge rates of 16/135 (11.85%) versus 7/143 (4.90%) between the two groups. 9 patients (6.67%) in the CO-CPR group versus 2 patients (1.40%) in the STD group with good neurological outcomes were obtained according to the CPC status, and the difference was statistically significant( P=0.003). And the Kaplan-Meier analysis showed a survival benefit favoring the CO-CPR group over the STD-CPR group at the end of the follow-up (P=0.007).

Conclusion: Patients who had suffered out-of-hospital cardiac arrest could achieve better survival benefits from CO-CPR than from STD-CPR.

Out-of-hospital cardiac arrest

Resuscitation

Chest compression

Abdominal compression-decompression

Prognosis

Cardiac arrest is a severe, life-threatening condition and remains a leading cause of out-of-hospital death worldwide. Adult out-of-hospital cardiac arrest (OHCA) patients have a low survival rate, at 10.4%, and only 8.2% of them survive with a good functional status^[1]. Standard cardiopulmonary resuscitation (CPR), consisting of chest compression and artificial ventilation, is considered the standard treatment for OHCA^[1–3]. Conventional chest compression does not always lead to a perfusion pressure sufficient to maintain vital organ blood flow and has not always fully restored cardiac and brain function^[4–7]. Moreover, chest compression may not be achievable when patients with chest wall trauma, rib fracture, or hemopneumothorax. How to raise or maintain the blood flow of the vital organs during CPR has been a question that clinicians have pondered for years.

Several studies have shown that the abdominal compression-decompression technique is associated with an increased coronary perfusion pressure and cerebral blood flow, which can lead to improved survival^[8–11]. However, this technique has been evaluated only with animal studies and case reports; therefore, there is a lack of information regarding this convenient procedure. In addition, this method is mainly performed manually and lacks any objective and visual parameters, such as the force or depth of the compression-decompression, and it can be difficult to perform this technique accurately. An abdominal CPR compression-decompression instrument, as an external and easy-to-use device, has the potential to be useful with out-of-hospital emergency medical services^{[11, 12]}, and it is worth investigating the combination of both conventional chest and abdominal compression-decompression techniques to determine whether there is a better prognosis resulting from the use of this combination.

Study design

This study was conducted at the Hefei Second People's Hospital, Hefei, China, between January 1, 2020, and December 31, 2020. The trial was retrospectively registered in the Chinese Clinical Trial Registry (registered number: ChiCTR2100049581). Registered 30 July 2021- Retrospectively registered, http://www.medresman.org.cn/uc/index.aspx. The study was approved by the Ethics Committee of the Second People’s Hospital of Hefei (The Affiliated Hefei Hospital of Anhui Medical University, approval number 2020-Science-025), and the requirement for informed consent was waived.

This trial is a single-center, prospective, randomized trial in which chest compression cardiopulmonary resuscitation after out-of-hospital cardiac arrest will be compared with a method combined with chest compression and abdominal compression-decompression cardiopulmonary resuscitation.

Patients

The inclusion criterion was out-of-hospital cardiac arrest in patients at least 18 years of age. Exclusion criteria were patients aged 80 years or older or had any contraindication criteria for the abdominal compression-decompression technique includes: pregnancy, any history of recent thoracic or abdominal trauma/surgery, known terminal or end-stage disease, or any severe neurologic impairment.

Randomization and blinding

Randomization will be performed by a statistics professional from our hospital. A random number table was generated using SPSS 18.0 software. Numbers from the table were assigned on a unified basis by the professional. A blinded assessor will evaluate the patient’s neurological prognosis. Outcome assessors and trial statisticians will also be blinded. While the clinical team responsible for the participant (physicians, nurses, and others) and involved with direct patient care will not be blinded to the allocation group due to the inherent difficulty in blinding the intervention.

Sample size

In randomized design, the sample size is often calculated by,${n}_{1}={n}_{2}=\frac{{\left({z}_{\alpha /2}+{z}_{\beta }\right)}^{2}\left[{p}_{t}\left(1-{p}_{t}\right)+{p}_{c}\left(1-{p}_{c}\right)\right]}{{\left({p}_{t}-{p}_{c}\right)}^{2}}$

Where ${p}_{t}$ and ${p}_{c}$ are the expected proportion of return of spontaneous circulation in CO-CPR group and STD-CPR group, respectively. ${Z}_{\alpha /2}$ and ${Z}_{\beta }$ are the upper $(\alpha /2)$th and $\beta$th percentiles of the standard normal distribution, respectively. In another similar research, Sisen Zhang et al calculated the minimum sample size with a ${p}_{t}$ value of 0.21 and a ${p}_{c}$ value of 0.48^[12]. In our study, we determined the expected difference in not only the proportion of return of spontaneous circulation rate, but also the neurological function and the survival between two groups in the sample size estimation. Therefore, we simplified the calculation as follows, and we usually assumed that$\alpha$ = 0.05, ${U}_{1-\alpha /2}=1.96$ and $d$ = 0.1.

$${n}_{1}={n}_{2}=\frac{{u}_{1-\alpha /2}^{2}\left[{p}_{1}\left(1-{p}_{1}\right)+{p}_{2}\left(1-{p}_{2}\right)\right]}{{d}^{2}}$$

And we planned to conduct an interim analysis to re-estimate the required sample size during the trial. From our study, we briefly summarized the proportion of return of spontaneous circulation as 20% approximately in both of the groups. The sample size was re-estimated as 122 cases for each group, and the final size increased to approximately 150 cases due to a drop-out rate of 20%.

Data collection and follow-up

Demographic characteristics (eg, age, sex, witness, bystander CPR) followed the Utstein resuscitation registry templates for out-of-hospital cardiac arrest. And we also recorded the clinical information of patient history.

All patients who were included in this study had a primary cardiac arrest, but cardiac arrests that occur outside the hospital are not always witnessed immediately. Therefore, the exact time from cardiac arrest to the initiation of CPR may not have been accurately determined in all cases for our study, then the no-flow time and initial presenting rhythm will be waived. Patients were followed up by three methods: outpatient visits, inpatient visits, or telephone calls. The patients were followed up by a blinded assessor every 1 to 3 months after discharge from the hospital, and the endpoint of the follow-up was the date of death, or until July 30, 2021.

Outcome measures

The primary outcome measure was return of spontaneous circulation (ROSC) rates. The secondary outcome measures included: survival to hospital admission rates, survival to hospital discharge rates, and neurological outcomes at hospital discharge. In addition, we also compared the Kaplan-Meier analysis at the end of the follow-up.

The neurological outcome was assessed by the Cerebral Performance Category (CPC) scale. The CPC scale categorizes the neurological outcomes as follows: CPC 1, good performance; CPC 2, moderate disability; CPC 3, severe disability; CPC 4, comatose or persistent vegetative status; and CPC 5, brain death or patient death^[13]. And we compared the prognosis between the two groups by classifying the case of CPC $<$ 3 as a good neurological outcome and the case of CPC $\ge$ 3 as a poor neurological outcome.

Instrument and intervention

Abdominal CPR compression-decompression instrument

The instrument, produced by the Beijing Germari Medical Equipment Co., Ltd, consisted of three components: a display panel, the pressure application handles, and a negative pressure device. A compression plate on the bottom of the negative pressure device had to be placed on the epigastrium. After turning on the device, negative pressure was generated, which caused a tight bond between these compression plates and the patient's abdomen. When we performed compression, the compression force was approximately 186 mmHg at the indicator light was on. While decompression was performed, the decompression force was approximately 112 mmHg. The abdominal compression-decompression could change the amplitude of the diaphragm motion, which plays a role of the cardiac pump, thoracic pump, and lung pump and enhance the blood flow to provide sufficient oxygen to vital organs.

The operating parameters were as follows: 1) The abdominal compression force was limited to 50 kg, and the decompression force was limited to 30 kg; the force levels were controlled from a light-emitting diode (LED) display panel on top of the instrument. 2) The compression-decompression frequency was marked by an audio signal with a frequency of 100 times/min. The training of emergency physicians was performed with the supervision of the monitoring staff of the manufacturer. Images of the device are shown in Fig. 1.

Interventions

In principle, CPR attempts were performed according to current American Heart Association guidelines^[1]. Except that patients were randomized to the treatment of CO-CPR instead of STD-CPR. We performed the chest compression with the abdominal compression-decompression alternately: When the chest was compressed, the abdominal simultaneously would be decompressed, and vice versa. Abdominal compression was performed at a rate of 100 times/min and a depth of 5–10 cm. The ratio of abdominal compression-decompression cycles to chest compression cycles, marked by the audio signal and delivered in alternation, was set to 1:1.

All methods were carried out following relevant regulations and guidelines. The effectiveness, safety, and stability of the abdominal compression-decompression device used in this study have been verified in human experiments^{[11, 12]}.

Patient and public involvement

No patient was involved.

Statistical analysis

PASS 15 software was used to calculate the sample size. (NCSS, LLC. Kaysville, Utah, USA). Statistical analysis was performed using SPSS version 18.0 (SPSS Inc., Chicago, IL, USA) and GraphPad Prism 8.0 (GraphPad Software, La Jolla, California, USA). The continuous variables were presented as the mean ± standard deviation (SD) and were analyzed by the independent sample t-test, while primary and secondary outcomes analysis was conducted using Pearson ${x}^{2}$tests for comparison. Kaplan-Meier curves, with the end of follow-up, were plotted to perform the survival analysis. A P-value less than 0.05 was considered statistically significant.

Patients

A total of 297 consecutive patients with OHCA were initially screened, and 278 were randomized to STD-CPR (n = 135) or CO-CPR (n = 143). Patient selection and reasons for exclusion are shown in Fig. 2. Patient baseline characteristics were similar in the two groups (Table 1.)

Table 1

Demographic characteristics of the STD-CPR and CO-CPR groups.
	CO-CPR	STD-CPR	P-value
	Total (n = 135)	Total (n = 143)	P-value
Age(Mean ± SD),y	58.33 ± 14.88	59.62 ± 14.91	0.471
Men,n(%)	100(74.07%)	101(70.63%)	0.521
Witness, n(%)	81(60.0%)	84(58.74%)	0.831
Bystander CPR, n (%)	51(37.78%)	50(34.97%)	0.626
History
Diabetes, n(%)	48(35.56%)	50(34.97%)	0.918
Hypertension, n(%)	64(47.41%)	63(44.06%)	0.575
Malignancy, n(%)	14(10.37%)	13(9.09%)	0.719
Lung insufficiency, n(%)	7(5.19%)	10(6.99%)	0.530
Stroke, n(%)	17(12.59%)	25(17.48%)	0.255
Chronic renal disease, n(%)	8(5.93%)	12(8.39%)	0.427
Cardiovascular disease, n(%)	77(57.04%)	69(48.25%)	0.143
COPD, n(%)	3(2.22%)	4(2.80%)	0.760
COPD = Chronic obstructive pulmonary disease

Primary outcome

In the primary analysis, 31(22.96%) patients in the CO-CPR group and 35(24.48%) patients in the STD-CPR group obtained ROSC respectively. The difference did not reach statistical significance (P = 0.767).

Secondary outcomes and follow-up

We also compared the survival to hospital admission rates, survival to hospital discharge rates, and neurological outcomes at hospital discharge between the two groups. 28 patients (20.74%) in the CO-CPR group and 33 patients (23.07%) in the STD-CPR group survival to hospital admission, with no significant difference between the groups (P = 0.638). However, there was a significant difference in the survival to hospital discharge rates of 16/135 (11.85%) versus 7/143 (4.90%) between the two groups. Patients’ survival with the good neurological outcome at discharge also varied according to the CPC status, and the difference was statistically significant (P = 0.003), details are shown in Table 2.

Table 2

Comparison of prognosis between the CO-CPR group and the STD-CPR group.
	CO-CPR	STD-CPR	P-value
	Total (n = 135)	Total (n = 143)	P-value
Survival to hospital admission, n(%)	28(20.74%)	33(23.07%)	0.638
Survival to hospital discharge, n(%)	16(11.85%)	7(4.90%)	0.035
Neurological outcome
Survival with good neurological outcome, n(%)	9(6.67%)	2(1.40%)	0.003

The follow-up evaluations were performed via outpatient visits for 3 patients, inpatient visits for 8 patients, and telephone calls for 23 patients. The follow-up time ranged from 1 to 529 days, and the average follow-up time was 61.75 ± 120.95 days. And the Kaplan-Meier analysis showed a survival benefit favoring the CO-CPR group over the STD-CPR group at the end of the follow-up (log-rank P = 0.007, Fig. 3).

When cardiac arrest occurs, conventional chest compression may enhance the blood flow to provide sufficient oxygen to vital organs. Various methods, such as the external cardiac compressor Zoll Auto-pulse and LUCAS chest compression system, have been applied to improve the efficiency and success rate. Unfortunately, several studies evaluated the success rate and prognosis between LUCAS and manual CPR but found that there was no meaningful difference between the two groups^[14–16]. In addition, chest compression cannot be effectively applied under some circumstances, such as chest wall deformity, rib fracture, or hemopneumothorax.

Abdominal compression-decompression cardiopulmonary resuscitation was invented as an alternative compression method to augment blood return and cardiac output. This new method could do help in building circulatory and respiratory support and be used in cardiac arrest patients with sternum and thoracic rib fracture. However, little is known about whether patients with OHCA could benefit from combined chest compression with abdominal compression-decompression during CPR duration.

In the present study, we aimed to investigate the benefit of combining conventional chest compression and abdominal compression-decompression CPR for adult out-of-hospital cardiac arrest patients. The outcome of ROSC rates and survival to hospital admission rates of this randomized trial in 278 patients with an out-of-hospital cardiac arrest did not result in a statistical significance between the two groups. However, we found that patients receiving the combination method in CO-CPR had higher survival to hospital discharge rates, better neurological outcomes at discharge according to the CPC status, significant survival benefits compared with those receiving chest compression in STD-CPR.

In most cases of primary cardiopulmonary arrest, blood still contains some oxygen during the early period. Conventional chest compression cardiopulmonary resuscitation is based on using a "thoracic pump," this is accomplished by compressing the mid-sternum, which increases the pressure inside the thorax, and blood is pumped out of the heart to the peripheral tissues including the brain^{[12, 17]}. In comparison, the abdominal compression-decompression technique is based on an "abdominal pump," model, which induces pressure changes within the abdominal cavity and promotes the return of blood from the abdominal cavity to fill the heart and be eventually pumped to the brain^{[18, 19]}. A combination of abdominal compression-decompression and chest compression was previously shown to increase the venous refilling of the heart, which could generate an increased coronary perfusion pressure and an increase in the blood flow to vital organs^{[10, 20, 21]}. In myocardial blood flow, a better 48-hour outcome was documented with the combination method compared with standard CPR^[22–25]. Hans-Richard Arntz et al. reported that the Lifestick device could perform both abdominal compression-decompression and chest compression, improve the results of CPR, and reduce the rate of injury compared to conventional resuscitation^[10]. This finding suggests that patients may benefit from the combination of both chest compression and abdominal compression-decompression techniques. However, studies that compare the results and the use of different devices from different institutions might have heterogeneous results, and the results of these types of studies might have limited applicability. In our study, the combination of the two CPR methods improved the survival rates and the neurological outcomes at discharge, and there was a survival benefit at follow-up, which confirmed Hans-Richard Arntz et al.'s observations. However, the device in our study was smaller in volume, more straightforward in operation, and more accurate in the operating parameters.

A significant advantage in using the new device for the combination of conventional chest compression and abdominal compression-decompression was that the instrument is small, lightweight, and easy to operate and could be suitable for hospital and non-hospital use in a variety of settings, including medical, sanitation, ambulance, rescue, and health care institutions at all levels inside and outside of the hospital.

This study has several limitations. The study was performed at a single center; one limitation of the study may be the relatively small number of subjects. Due to the limited sample size, most cases of cardiac arrest occurred among older patients. Autopsies were not performed in non-survivors; therefore, we were not able to determine whether the abdominal compression-decompression technique resulted in abdominal injuries in this study. And the CO-CPR method requires one more rescuer than for STD-CPR.

In summary, we conclude from our results that patients could benefit from the combination of conventional abdominal compression-decompression and chest compression. Clearly, a large-scale clinical trial should be performed with this promising new technique to get a more comprehensive evaluation of its use.

CPR: cardiopulmonary resuscitation; STD-CPR: standard (or chest compression) cardiopulmonary resuscitation; CO-CPR: combination of chest compression and abdominal compression-decompression cardiopulmonary resuscitation; OHCA: out-of-hospital cardiac arrest; ROSC: return of spontaneous circulation; AHA: American Heart Association; LED: light-emitting diode; CPC: Cerebral Performance Category; SD: standard deviation; COPD: Chronic obstructive pulmonary disease.

Ethical approval and consent to participate

Institutional Review Board approval was obtained from the ethics committee of the Second People’s Hospital of Hefei (approval number: 2020-Science-025).

Consent for publication

Not applicable.

Availability of data and materials

All study data are available upon reasonable request from the corresponding author and may be reused as required (We also uploaded main part of data in network of Clinical Trial Management Public Platform, http://www.medresman.org.cn).

Competing interests

The authors of this manuscript declare that they have no relationships with any companies whose products or services may be related to the subject matter of the article.

Funding

This work was supported by the Applied Medicine Program Foundation of Hefei (No. Hwk2021yb011) and the Science & Technology Program of Anhui Medical University (No. 2020xkj251).

Authors’ contributions

HaiShan Li conceptualized the study and performed funding acquisition. Chao wang wrote the manuscript. Hongyuan Zhang performed formal analysis. Fang Cheng supervised the study and performed data curation. Shuang Zuo performed randomization and allocation. Liyou Xu performed software analysis. Hui Chen and Xiaodong Wang were equally contributing in investigation. And all authors reviewed the manuscript.

Acknowledgments

Not applicable.

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You are reading this latest preprint version

Evaluation of Abdominal Compression-Decompression Combined With Chest Compression CPR Performed by a New Device: Is the Prognosis Improved After This Combination CPR Technique?

Status:

Version 1

Abstract

Figures

Background

Materials And Methods

Study design

Patients

Randomization and blinding

Sample size

Data collection and follow-up

Outcome measures

Instrument and intervention

Abdominal CPR compression-decompression instrument

Interventions

Patient and public involvement

Statistical analysis

Results

Patients

Primary outcome

Secondary outcomes and follow-up

Discussion

Conclusion

Abbreviations

Declarations

References

Supplementary Files

Status:

Version 1