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Asian Journal of Surgery xxx (xxxx) xxx

Contents lists available at ScienceDirect

Asian Journal of Surgery


journal homepage: www.e-asianjournalsurgery.com

Original Article

An expandable one-way-valve device for chest wound treatment:


Evaluation of open pneumothorax in a canine model
Weijin Yang a, 1, Youxu Zhou b, 1, Jianshen Qiu c, Chaochao Tao d, Weihang Wu a, Nan Lin a,
Chao Yang c, Ji Zhang c, Hongwen Zhang c, *, Yu Wang a, **
a
Department of General Surgery, 900 Hospital of the Joint logistics Team, Dongfang Hospital, Xiamen University, Fuzhou, Fujian, China
b
Department of General Surgery, The Third Affiliated Hospital of Fujian Traditional Chinese Medical University, Fuzhou, Fujian, China
c
Interventional Ward, Department of Medical Imaging, 900 Hospital of the Joint logistics Team, Dongfang Hospital, Xiamen University, Fuzhou, Fujian,
China
d
Department of Radiology, 900 Hospital of the Joint logistics Team, Dongfang Hospital, Xiamen University, Fuzhou, Fujian, China

a r t i c l e i n f o a b s t r a c t

Article history: Background/objective: Thoracic injuries commonly occur after blunt or penetrating trauma, leading to a
Received 17 October 2019 blowing wound. For thoracic damage control in emergency, we evaluated a novel chest wound treatment
Accepted 20 October 2019 device manufactured using expandable material with a one-way valve, and compared it with closed
Available online xxx
thoracic drainage for first-line treatment of traumatic pneumothorax in a canine model.
Methods: Twenty beagle dogs (10 males and 10 females) were randomly and equally divided into two
Keywords:
groups. After arteriovenous catheterization, an open pneumothorax model was established in the beagle
Expandable device
dog using a minimally invasive procedure. The experimental group was treated using our test device,
Pneumothorax
Trauma
while the control group was treated by closed thoracic drainage. Animal survival, oxygen saturation
(SO2), oxygen pressure (PO2), and changes in chest radiograph with reference to open pneumothorax
before and after intervention were recorded at 30, 60, and 120 min.
Results: After a 24-h experimental period, all animals survived. The control group recovered more
quickly than the experimental group at 30 min post-trauma. However, the indices were close to normal
120 min after the test device was inserted. During the puncture, chest-wall hemorrhage was stopped by
using the device, whereas the control group experienced continual errhysis. The lung had almost re-
expanded at the end of the experiment in both groups. The effect of pulmonary re-expansion in the
control group was better than that in the experimental group at 120 min.
Conclusion: The novel expandable one-way valve device is a safe and useful tool for the treatment of
open chest trauma in emergency based on our animal experiment.
© 2019 Asian Surgical Association and Taiwan Robotic Surgery Association. Publishing services by
Elsevier B.V. This is an open access article under the CC BY-NC-ND license (http://creativecommons.org/
licenses/by-nc-nd/4.0/).

1. Introduction pneumothorax1 and accounts for 25% of all trauma mortality.2


Traumatic pneumothorax is a leading cause of preventable mor-
Thoracic injuries are very common following blunt or pene- tality in patients who experienced multiple traumas.3 During pe-
trating trauma. They always lead to a blowing wound or open riods of war, open thoracic trauma is a more common injury and the
second most common cause of death.4 An accurate and rapid pre-
hospital response to life-threatening injuries is of great impor-
* Corresponding author. Interventional Ward, Department of Medical Imaging, tance in both civil and military critical care. In civilian settings, most
900 Hospital of the Joint logistics Team, Dongfang Hospital, Xiamen University, thoracic trauma is managed using supplemental oxygen, tube
Fuzhou, Fujian, 350025, China.
thoracostomy, and mechanical ventilation when necessary. How-
** Corresponding author. Department of General Surgery, 900 Hospital of the Joint
logistics Team, Dongfang Hospital, Xiamen University, Fuzhou, Fujian, 350025, ever, none of these are likely to be available or advisable in
China. resource-poor settings.5
E-mail addresses: zhanghw1983@126.com (H. Zhang), flyfishwang@hotmail. The utilization of damage control surgery is considered routine for
com (Y. Wang). severe abdominal trauma, and only recently, this strategy has been
1
Weijin Yang and Youxu Zhou contributed equally to this work.

https://doi.org/10.1016/j.asjsur.2019.10.013
1015-9584/© 2019 Asian Surgical Association and Taiwan Robotic Surgery Association. Publishing services by Elsevier B.V. This is an open access article under the CC BY-NC-
ND license (http://creativecommons.org/licenses/by-nc-nd/4.0/).

Please cite this article as: Yang W et al., An expandable one-way-valve device for chest wound treatment: Evaluation of open pneumothorax in a
canine model, Asian Journal of Surgery, https://doi.org/10.1016/j.asjsur.2019.10.013
2 W. Yang et al. / Asian Journal of Surgery xxx (xxxx) xxx

utilized in thoracic trauma. The general principles and goals of


thoracic damage control are similar to those employed in abdominal
trauma with expeditious management of unstable patients remaining
the primary focus. However, severe thoracic injuries are often rapidly
fatal without prompt intervention.21,22 Therefore, temporizing tech-
niques can be used as currency to buy time for physiological correc-
tion in exsanguinating patients before definitive treatment.
The updated Tactical Combat Casualty Care (TCCC) Guideline for
battle field management of open pneumothorax states that all open
and/or sucking chest wounds should be treated by immediately
applying a vented chest seal to cover the defect. If a non-vented
chest seal is used, the casualty may potentially develop a subse-
quent tension pneumothorax.6 At this point, commercially avail-
able vented chest seals incorporate a valve into their design to allow Fig. 1. A novel chest wound treatment device manufactured using expandable mate-
rial with a one-way valve.
a one-way flow of air out of the pleural space on exhalation but do
not permit air back into the pleural space on inspiration. For
example, the Asherman, Hyfin, and Bolin chest seals have been (10 mg/kg; intramuscularly). Induction was conducted with an
recommended as faster and more reliable approaches to manage an intravenous bolus of ketamine and diazepam (12e15 mg/kg) and
open pneumothorax than a three-sided dressing.7,8 However, while delivery was maintained at a speed of 1 mg/kg/h. A femoral artery
those devices can discharge gas from the chest, they cannot stop catheter was placed inside the left femoral artery for blood sam-
hemorrhage d another important cause of death.9 Therefore, there pling (blood lactate and blood gas analysis). Another catheter was
is a clinical requirement for a device with a one-way valve that can placed in the left forelimb vein for anesthesia and intravenous fluid
simultaneously discharge gas and stop hemorrhage. infusion. In this study, a hemorrhagic shock model was established
Here we present findings from a novel chest wound treatment in dogs to simulate the scenario of rescue in battlefields. Soldiers
device manufactured using expandable material with a one-way who are wounded in battlefields are often associated with bleeding.
valve, and compared this intervention with closed thoracic According to the damage control theory, in emergency conditions,
drainage. We used a beagle dog model assessing response to open fetal wounds should be treated with emergency measures that are
pneumothorax. The aim of the study was to test the applicability of simple, feasible, effective, and less damaging; after resuscitation,
the novel device as a preliminary step for the treatment of open then staged surgery can be planned to treat non-fetal wounds.
chest trauma, and to verify whether this device could both seal the Hemorrhagic shock was induced with hemorrhage from the jugular
chest and discharge the gas while stopping blood loss. artery to maintain the mean arterial pressure at 40 mmHg in
20 min. Fluid resuscitation with Ringer's solution was initiated
2. Materials and methods
30 min after the hemorrhagic shock.23 Warm lactated Ringer's
solution was administered intravenously during surgery at 5 mL/
2.1. Animals
kg/h. The chest, groin, and abdomen of each animal were shaved
and the skin prepared for aseptic surgery.
Ten male and ten female beagle dogs were included in this study.
The body weight of the dogs ranged from 12 to 18 kg. The dogs were
housed individually in cages (1.0  1.0  1.0 m). During the study, the
dogs were fed with a sufficient fixed quantity of processed dog food. 2.3.2. Establishment of an open pneumothorax model using a
All dogs were fasted for 12 h before experimentation and then minimally invasive procedure
randomly and equally divided into two groups. Use of all experi- The dogs were immobilized on the X-ray system after anesthesia
mental animals was approved by Zhenhe Laboratory Animal Co., Ltd. and arteriovenous catheterization. Following skin decontamination
(Fuzhou, Fujian Province, China). The study protocol was approved with iodophor, we used a 5-mm trocar to stab the right-side of the
by the Ethics Committee of Fuzhou General Hospital. chest wall in the vicinity of the subcostal gutter of the upper rib, in
the fifth intercostal space approximately 10 cm from the sternum.
2.2. Materials The trocar's inner core was withdrawn until the sharp blade
retraction click was noted. Forty minutes later, the pneumothorax
A novel chest wound treatment device was invented by our line (the compressed lung edge) was evaluated by X-ray (Fig. 2) and
group. The device had a composite structure and was composed of the open pneumothorax model was validated.11 Blood sampling
polyvinyl alcohol. The main body was 8 cm long and 1.5 cm wide. was performed once more after the model was confirmed (blood
The inner core was a silicone hollow pipe, 9 cm long, with an lactate and blood gas analysis).
external diameter of 5 mm and an inner diameter of 3 mm. There
was a one-way valve at the end of this device (Fig. 1).
Single-use trocars (12 and 5 mm) were supplied by Kangji 2.3.3. Application of the novel device in the experimental group
Medical Instrument Co. Ltd. (Hangzhou, Zhejiang Province, China) A 12-mm single-use trocar was used to stab the right-side of the
A Shimadzu X-ray system was supplied by Sonialvision Safire 17 chest wall in the vicinity of the subcostal gutter of the upper rib, in
(Shimadzu Corp., Kyoto, Japan). Fully automatic arterial blood gas the fifth intercostal space approximately 10 cm from the sternum.
analysis was performed using a disposable i-STAT1 EG7þ chest The trocar was withdrawn until the sharp blade retraction click was
closing drainage device (Abbott, Abbott Park, IL, USA). noted. Our test device was inserted immediately and the valve of
the 5-mm trocar was then turned off (Fig. 3). The device was con-
2.3. Methods nected to a drainage pack. The speed and capacity of drained fluid
were recorded. Blood samples were obtained on one more occasion
2.3.1. Establishment of arteriovenous passage after an hour (blood lactate and blood gas analysis). All subjects
All dogs were anesthetized with ketamine and diazepam underwent a chest radiograph once more.

Please cite this article as: Yang W et al., An expandable one-way-valve device for chest wound treatment: Evaluation of open pneumothorax in a
canine model, Asian Journal of Surgery, https://doi.org/10.1016/j.asjsur.2019.10.013
W. Yang et al. / Asian Journal of Surgery xxx (xxxx) xxx 3

2.4. Data analysis

Data are expressed as means ± standard error of the mean


(n ¼ 10). Between-group analysis (experimental group vs. control
group) was performed using two-way repeated measures analysis
of variance using SAS 9.4 (SAS Institute Inc., Cary, NC, USA). A
p < 0.05 was considered significantly different.

3. Results

3.1. Animal survival and the status of the device

After the 24-h experiment, all animals survived. In the experi-


mental group, eight lungs of the dogs almost re-expanded by the
end of the experiment. Nine test devices were completely swollen.
None of the devices fell off during the experimental period. In the
control group, nine lungs of the dogs had almost re-expanded by
120 min. One of the intrathoracic drainage tubes had been bitten off
during postoperative care. After puncture, chest-wall hemorrhage
was stopped by the test device, while errhysis was present in the
control group.

Fig. 2. The pneumothorax line (indicated by arrows) in an experimental dog before 3.2. Comparison of oxygen saturation and oxygen pressure between
intervention. two groups

Compared with the control group, the experimental group had


significantly lower levels of oxygen saturation (SO2, %) at 30 min
(91.8 ± 6.23 vs. 79.2 ± 4.66, p ¼ 0.0032; Table 1) and oxygen
pressure (PO2, mmHg) at 30 and 60 min post-intervention
(88.3 ± 5.91 vs. 52.3 ± 5.56, p < 0.0001 and 86 ± 4.71 vs.
72.2 ± 9.74, p ¼ 0.0351; Table 2). However, at 120 min post-
intervention, both indices were comparable in the control and
experimental groups.

3.3. Changes in oxygen saturation and oxygen pressure across


different time points

In the experimental group, the oxygen saturation level averaged


94.7% at the beginning of the experiment and decreased to 72.4%
after pneumothorax. It then slightly increased to 79.2% after
insertion of the device and reached 91.5% at the end of the exper-
iment (Fig. 4). Similar changes were observed in the oxygen

Fig. 3. Insertion of the novel device into the dog's chest. Table 1
Comparison of oxygen saturation (SO2, %) at each time point between experimental
and control groups of beagle dogs.
2.3.4. Application of closed thoracic drainage in the control group Time Control Experimental p
The dog's chest wall was stabbed as did in the experimental
Before pneumothorax 94.2 ± 1.23 94.7 ± 0.82 1
group. The trocar was withdrawn and a 30F intrathoracic drainage After pneumothorax 74.9 ± 4.18 72.4 ± 2.99 1
tube was inserted percutaneously into the right pleural space. The 30 min post-intervention 91.8 ± 6.23 79.2 ± 4.66 0.0032
drainage tube was linked with a water-sealed bottle. Blood samples 60 min post-intervention 91.9 ± 3.51 86.7 ± 11.5 1
were obtained once more after an hour (blood lactate and gas 120 min post-intervention 90.5 ± 4.45 91.5 ± 11.62 1

analysis). All animals underwent chest radiograph once more. Note: Data are the means ± standard deviation (n ¼ 10).

2.3.5. Postoperative care Table 2


Postoperative dogs were fed with a sufficient fixed quantity of Comparison of oxygen pressure (PO2, mmHg) at each time point between the
processed dog food after they had recovered from anesthesia. Be- experimental and control groups of beagle dogs.
tween 6 and 24 h post-surgery, we observed the survival of the Time Control Experimental p
dogs, the status of our device (position and swelling), and the
Before pneumothorax 81 ± 2.26 79.2 ± 2.49 1
occurrence of hemorrhage or errhysis in the chest wall. After 24 h, After pneumothorax 47.8 ± 3.91 44.5 ± 3.87 1
we pulled out the device in the experimental group while 30 min post-intervention 88.3 ± 5.91 52.3 ± 5.56 <0.0001
extracting the closed chest drainage tube and the intrathoracic 60 min post-intervention 86 ± 4.71 72.2 ± 9.74 0.0351
drainage tube in the control group. We then sutured the wound in 120 min post-intervention 82.8 ± 7.45 84.7 ± 16.99 1

the dog's chest. Note: Data are the means ± standard deviation (n ¼ 10).

Please cite this article as: Yang W et al., An expandable one-way-valve device for chest wound treatment: Evaluation of open pneumothorax in a
canine model, Asian Journal of Surgery, https://doi.org/10.1016/j.asjsur.2019.10.013
4 W. Yang et al. / Asian Journal of Surgery xxx (xxxx) xxx

Fig. 4. Changes in oxygen saturation (SO2, %) level at different time points in the experimental and control groups.

pressure level in the experimental dogs, which markedly decreased 4. Discussion


from 79.2 mmHg at the beginning to 44.5 mmHg after pneumo-
thorax. It then increased to 52.3 mmHg after insertion of the device This study has invented a novel device for the treatment of open
and finally reached 84.7 mmHg by the end of the experiment chest wound in emergency. In the animal experiment, we observed
(Fig. 5). no active hemorrhage or errhysis in the chest wall of experimental
In the control group, the oxygen saturation level averaged 94.2% dogs treated by this device, thus demonstrating its applicability.
at the beginning and decreased to 74.9% after pneumothorax. It The main body of this novel device is composed of a high polymer
then increased to 91.8% after insertion of the device and slightly material d polyvinyl alcohol d in a compressed state, with a one-
decreased to 90.5% by the end of the experiment (Fig. 4). Similarly, way valve at its end. When the device is inserted into the wound, it
the oxygen pressure level initially decreased from 81.0 mmHg at absorbs blood and swells immediately. In this way, it can block off
the beginning to 47.8 mmHg after pneumothorax. It then increased the chest wound while discharging gas or liquid from the chest
to 88.30 mmHg after insertion of the device and subsequently through the one-way valve. This device is handy, small, and
dropped to 82.8 mmHg by the end of the experiment (Fig. 5). exquisite. In addition, it can be easily operated by one person.
Importantly, the device meets physical requirements for both
military and civilian uses.
3.4. Chest radiography of the open pneumothorax model The “golden hour” is typically defined as the hour-long window
of clinical opportunity after trauma. The survival rate may be
The chest radiograph of the open pneumothorax model showed improved with timely treatment of pneumothorax. Otherwise, it
that, by the end of the experiment, the pneumothorax line had may result in life-threatening symptoms such as severe respiratory
almost faded in the experimental (Fig. 6) and control (Fig. 7) groups. distress, hyper-resonance, absence of breathing sounds, tracheal
However, the lung had almost re-expanded. deviation, and unstable hemodynamics.12,13 Following the direction

Fig. 5. Changes in oxygen pressure (PO2, mmHg) level at different time points in the experimental and control groups.

Please cite this article as: Yang W et al., An expandable one-way-valve device for chest wound treatment: Evaluation of open pneumothorax in a
canine model, Asian Journal of Surgery, https://doi.org/10.1016/j.asjsur.2019.10.013
W. Yang et al. / Asian Journal of Surgery xxx (xxxx) xxx 5

Fig. 6. Changes in chest radiograph of the dog model of open pneumothorax before (A) and after (B) experimentation (experimental group).

of thoracic damage control, temporary chest closure allows us to in the experimental group did not recover as fast as those in the
rapidly close the thoracic cavity and get these critically ill patients control group, the indices for both groups were close to normal
to the ICU, where resuscitation is more efficient. Some researchers 120 min after insertion of the device. These results indicate that it is
recommend using a damage-control strategy and temporary chest safe and feasible to use our device for the treatment of open
closure in patients with thoracic injuries and clinical disseminated pneumothorax in animals. Despite its slightly smaller effect than
intravascular coagulation, hypothermia, and academia.24 the golden standard (closed thoracic drainage), our device can be
The study reported here has examined the ability of the used for first-line treatment through operation by one person.
expandable one-way-valve device to treat open pneumothorax in In the control group, the intrathoracic drainage tube was
dogs as a first-line therapy. In the experimental dogs, those indices inserted percutaneously into the right pleural space. Faster changes
that were initially affected by the device inserted into the chest occurred in the main indices compared with those in the experi-
wound had almost gradually returned to normal levels by the end mental group, and this difference may be due to the pipe diameter
of the experiment. The pneumothorax line had also faded away by of the intrathoracic drainage tube being bigger than our device.
the end of the experiment, which implied that the lung had almost Although oxygen saturation and oxygen pressure significantly
re-expanded. The blood gas pH changed a little before and after the improved after a short time, these indices eventually declined over
experiment. Although the oxygen saturation and oxygen pressure time. Catheter malpositioning may be the primary cause, as this

Fig. 7. Changes in chest radiograph of the dog model of open pneumothorax before (A) and after (B) experimentation (control group).

Please cite this article as: Yang W et al., An expandable one-way-valve device for chest wound treatment: Evaluation of open pneumothorax in a
canine model, Asian Journal of Surgery, https://doi.org/10.1016/j.asjsur.2019.10.013
6 W. Yang et al. / Asian Journal of Surgery xxx (xxxx) xxx

phenomenon was observed in several dogs. Availability of data and materials


Traditional approaches to the diagnosis and management of
pneumothorax are being challenged, and physicians should main- The datasets analysed in the current study are available from the
tain an open mind regarding new approaches to this condition.17e19 corresponding author on reasonable request.
The device reported in this study is soft when it absorbs blood and
swells. Consequently, there is a slim chance that the lung lobe can Funding
be harmed. Based on our study, we should be prepared to translate
these lessons learned to care for injuries in the battlefield or in This study was supported by the Key Project of 900 Hospital of
areas lacking resource. For significant thoracic trauma, provision of the Joint logistics Team (2015J01), the Key Medicine Project of PLA
equipment and necessary training in applying vented chest seals (CNJ15J004), the National Science and Technology Major Project of
with one-way valves may be life-saving. It is also possible that China (2018ZX09J18), the Natural Science foundation of Fujian
simple “rodlike” devices coupled with a vented chest seal may also Province (NO.2017J01317, NO.2017J01327), B. Braun Anesthesio-
be life-saving. logical Research Foundation (SH50)and the Cooperate Project of
There were a few limitations in this study. First, the novel device Fujian Province (2017I0015).
could occasionally fall off during the treatment. In addition, the size
of this device was limited. However, this animal study has focused Declaration of competing interest
on a potentially survivable wound, examples being gunshot or knife
wounds. If the hole of the wound is bigger than our device e.g., by a The authors declare that they have no competing interests.
rifle shot, we believe such victims would die immediately. Second,
the sample size of the study was relatively small, but given the big
Acknowledgements
size of our experimental animals, the sample size is deemed
reasonable. Third, the amount of blood loss from the thoracic injury The authors thank the staff from the Animal Experimental
was not quantified because we were unable to visualize the inside
Center and the Department of Pathology at 900 Hospital of the Joint
of the chest or the amount of internal hemorrhage, and only local logistics Team for their help.
hemostasis could be seen. To remedy this shortcoming, we will
inject increasing volumes of blood as well as air in the subjects in
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Please cite this article as: Yang W et al., An expandable one-way-valve device for chest wound treatment: Evaluation of open pneumothorax in a
canine model, Asian Journal of Surgery, https://doi.org/10.1016/j.asjsur.2019.10.013

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