1

Title

Endoscopic shield: barrier enclosure during the endoscopy to prevent aerosol droplets during the

COVID-19 pandemic

Ryota Sagami, MD,1 Hidefumi Nishikiori, MD,1 Takao Sato, MD,1 Kazunari Murakami, MD, PhD2

Affiliations

1) Department of Gastroenterology, Oita San-ai Medical Center, Oita, Japan

2) Department of Gastroenterology, Faculty of Medicine, Oita University, Oita, Japan

Author contributions:

Ryota Sagami - served as project principal investigator, and supervised the overall conduct of the

study; developed the study concept and design, performed data curation, formal analysis, validation,

and visualization, drafting of the manuscript and critical revision of the manuscript.

Hidefumi Nishikiori - assisted with the study concept and design, material support, acquisition of

data, and drafting of the manuscript.

Takao Sato - assisted with the study concept and design, acquisition of data, and drafting of the

manuscript.

Hiroaki Tsuji - assisted with the study concept and design, acquisition of data, and drafting of the

manuscript.

Kazunari Murakami - performed project administration, supervision, writing-review, and editing of

the manuscript.

All authors provided final approval of the article prior to submission.

Corresponding Author contact information:

Ryota Sagami, MD.

Cover page

2

Department of Gastroenterology, Oita San-ai Medical Center, Oaza Ichi 1213, Oita, Oita 870-1151,

Japan.

Tel: +81-97-541-5218

Fax: +81-97-541-1311

Email: sagami1985@yahoo.co.jp

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Title

Endoscopic shield: barrier enclosure during the endoscopy to prevent aerosol droplets during the

COVID-19 pandemic

Coronavirus disease 19 (COVID-19) refers to human infection with severe acute

respiratory syndrome coronavirus 2 (SARS-CoV-2). The World Health Organization (WHO)

declared COVID-19 a pandemic on March 11, 2020. By April 21, 2020, the number of confirmed

COVID-19 cases had increased to more than 2,397,000 globally, with an overall mortality rate of

6.8%.1

COVID-19 is mainly spread through direct contact or aerosol droplets.2,3 Whether

endoscopy represents an aerosol-generating procedure remains unclear, but insufflation during

endoscopic procedures could cause splash and aerosol droplets due to processes such as reflex

vomiting, sneezing, and coughing. Contamination by such aerosol droplets may increase the risk of

SARS-CoV-2 transmission. In areas with many infected patients, about 10% of healthcare

personnel (HCP) have been shown to contract COVID-19, and protection of HCP is recommended.4

However, HCP involved in endoscopy face substantial risks due to the short physical distance

between patients and personnel. Many endoscopic centers have thus reduced normal endoscopic

activities.5

Triage and assessment of risk from patients with suspected or confirmed COVID-19 before

endoscopy, regular monitoring of the supply and use of personal protective equipment (PPE), and

performance of endoscopies in a negative pressure room, when available, with strict isolation

precautions for suspected or confirmed cases of COVID-19 are recommended.2 In addition, urgent

Text

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endoscopies, such as for upper GI bleeding or severe cholangitis, should be performed by

strategically assigned HCP to minimize risks of concomitant exposure.2

Description of technology

Protection against COVID-19 infection during endoscopic procedures due to splash and

aerosol droplets should be considered from not only the side of the HCP, but also the side of the

patient. Newly developed barrier enclosures for use during endotracheal intubation may reportedly

provide additional protection as an adjunct to standard PPE, from the perspective of preventing the

spread of aerosol droplets.6 With reference to that report, the Endoscopic Shield was developed.

This plastic cube barrier was designed to cover the head of the patient during upper GI endoscopy.

Video description

This device is a plastic cube with sides of 45 centimeters. Four square 1.5-mm-thick plastic

plates were glued together, with 2 holes in the plate on the facial side. With the patient in a left

lateral position, the foot side and left side of the cube are open, and the head of the patient is

covered, especially on the facial side (Fig. 1A). In our situation, a 170-cm tall endoscopist in

standard PPE performed upper gastrointestinal endoscopy on a mannequin with the mouthpiece

placed as usual. The facial side of the cube contains 2 small holes, each 2 cm in diameter, and the

endoscope is inserted through one of the holes, selected according to the size of the patient's face

and the height of their mouth (Fig. 1B and C). The other hole is closed with medical tape (Fig. 1C).

The size of the hole was determined based on the diameter of the TJF-260V side-view endoscope

(Olympus Medical Systems, Tokyo, Japan) with a diameter of 13.5 mm and working space because

that endoscope has the largest diameter of any endoscope in Japan and is used for urgent endoscopic

retrograde cholangiopancreatography. A single episode of reflex vomiting or cough was simulated

by bursting a small nitrile rubber balloon containing 10 mL of fluorescent dye. The balloon was

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attached to a tube and placed in the hypopharynx of the mannequin, then oxygen was pumped

through the tube inside the mannequin until the balloon burst. Simulated endoscopy was then

performed without and with placement of the endoscopic shield. The scene for each simulation was

illuminated with ultraviolet light to visualize the area of scattered dye droplets.

In the situation without the endoscopic shield, dye was clearly identified on the right glove,

arm, upper chest, abdomen, and socks of the endoscopist (Fig. 2A). Barely any dye was identified

on the face mask or eye shield. Contamination of the floor occurred within approximately 1.5 m

from the head of the bed (Fig. 2B). With the endoscopic shield, most dye was identified on the inner

front surface of the cube, on the inner upside surface to a lesser extent, and not on other surfaces

(Fig. 3). A little dye was found only on the right glove, arm, and chest of the endoscopist, with none

on the abdomen, socks (Fig. 2C), face mask, or eye shield. Contamination of the floor was also

minimal (Fig. 2D). The endoscopic shield thus appeared to protect against the widespread dispersal

of aerosol droplets. Given this situation, the endoscopic shield could prevent the majority of splash

and aerosol droplets from a patient, markedly reducing the exposure of HCP including endoscopists

and the surrounding environment such as floors.

Use in an actual patient procedure

Next, use of the endoscopic shield for a live patient was evaluated. One of the authors

underwent upper gastrointestinal endoscopy with the endoscopic shield without conscious sedation,

after informed consent was obtained. The patient was placed in a left lateral position, and the

endoscopic shield was placed to cover the head. There was no discomfort, and the vital signs did

not change.

When the endoscopic procedure is performed with conscious sedation, the cube can be

placed after the start of sedation. The endoscope was inserted through one of the holes on the facial

side of the cube. A disposable rubber check valve was attached to one hole to suppress infection

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with contact of the endoscope. During the procedure, head repositioning was performed without

difficulty because of the sufficient working space in the cube, and a nasal cannula was smoothly

inserted through the foot side of the cube during the procedure. The standard gastrointestinal

screening was completed in about 10 minutes without problems, and there was no interference

between the endoscope and the endoscopic shield. After the procedure, many droplets due to reflex

vomiting and coughing were confirmed on the inner front surface of the cube. The attached check

bulb was abandoned, and the cube was carefully washed and wiped with sodium hypochlorite.

Because the endoscopic shield is an external device, the device could be reusable with such

disinfection.

The device may be useful for all patients who undergo upper gastrointestinal endoscopy,

including urgent endoscopic procedures. However, the device may have little to no clinical

applicability for patients undergoing general endotracheal intubation, because aerosolization would

not be a concern in such cases. The new device was easy to use, and no particular training was

required. Of course, our simulation only partially reproduced the true situation of endoscopy and

could not identify whether the shield prevented widespread dispersal of smaller aerosol particles

that could still prove infectious. In addition, access to the patient may be restricted by the device

depending on the situation. However, the shield has the possibility of providing an additional level

of protection against COVID-19 infection spreading during necessary endoscopic procedures. The

prototype of the endoscopic shield was easy and inexpensive to produce, at a price of $40 USD;

therefore, commercialization of this device is now planned. However, the shape and durability

should be considered in detail for it to be commercialized.

Conclusion

The endoscopic shield could prevent widespread dispersion of aerosol droplets, and HCP,

including endoscopists and surrounding environments such as floors, were exposed only slightly

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with endoscopic shield use. Therefore, the endoscopic shield may reduce the spread of COVID-19

infection during endoscopy.

References

1. World Health Organization. Situation report -92, 2020. Available at:

https://www.who.int/docs/default-source/coronaviruse/situation-reports/20200421-sitrep-92-

covid-19.pdf?sfvrsn=38e6b06d_4.

2. Chiu PWY, Ng SC, Inoue H, et al. Practice of endoscopy during COVID-19 pandemic: position

statements of the Asian Pacific Society for Digestive Endoscopy (APSDE-COVID statements).

Gut. Epub 2020.

3. van Doremalen N, Bushmaker T, Morris DH, et al. Aerosol and Surface Stability of SARS-

CoV-2 as Compared with SARS-CoV-1. N Engl J Med. 2020;382:1564-7

4. The Lancet. COVID-19: protecting health-care workers. Lancet. 2020;395:922.

5. Repici A, Aragona G, Cengia G, et al. Low risk of covid-19 transmission in GI endoscopy.

Gut. Epub 2020 Apr 22.

6. Canelli R, Connor CW, Gonzalez M, et al. Barrier Enclosure during Endotracheal Intubation. N

Engl J Med. Epub 2020 Apr 3.

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Video Legend

Video demonstration of the way to use the endoscopic shield and the effectiveness of the device

from the perspective of preventing the spread of aerosol droplets.

Figure Legends

Figure 1. Details of the endoscopic shield. A, This device is a plastic cube with sides of 45

centimeters. With the patient in a left lateral position, the foot side and left side of the cube are

open, and the head of the patient is covered. B and C, The facial side of the cube contains 2 small

holes, and the endoscope is inserted through one of the holes, selected according to the size of the

patient's face and the height of their mouth. The other hole is closed with medical tape.

Figure 2. Comparison of the spread of fluorescent dye droplets from a simulated patient cough

during endoscopy. A and B, Dye was identified a lot on the right glove, arm, chest near the neck of

the endoscopist. In addition, much contamination of the floor occurred after the simulated

endoscopy without the endoscopic shield. C and D, A little dye was found only on the right glove,

arm, and chest of the endoscopist, and contamination of the floor was also minimal after the

simulated endoscopy with the endoscopic shield.

Figure 3 Most dye was identified on the inner front surface of the endoscopic shield.

Legends

Fig 1A-C Click here to access/download;Figure;Sagami Fig 1A-C.tif

Fig 2A Click here to access/download;Figure;Sagami Fig 2A.tif

Fig 2B Click here to access/download;Figure;Sagami Fig 2B.tif

Fig 2C Click here to access/download;Figure;Sagami Fig 2C.tif

Fig 2D Click here to access/download;Figure;Sagami Fig 2D.tif

Fig 3 Click here to access/download;Figure;Sagami Fig 3.tif

VIDEO LINK:

https://asge.sharefile.com/d-s5dd5994a6314bb7a

Video customized with template

Click here to access/downloadVideo customized with template

movie.mp4

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VideoGIE Journal CME Conflict of Interest: Disclosure and Attestation

Lead Author: Ryota Sagami

Article: Endoscopic Shield: Barrier enclosure during the endoscopy to prevent aerosol droplets during the COVID-19 pandemic

Date: April 27, 2020

The purpose of this form is to identify all potential conflicts of interests that arise from financial relationships between any author for this article and any commercial or proprietary entity that produces healthcare-related products and/or services relevant to the content of the article. This includes any financial relationship within the last twelve months, as well as known financial relationships of authors’ spouse or partner. The lead author is responsible for submitting the disclosures of all listed authors, and must sign this form at the bottom. Additional forms may be submitted if the number of authors exceeds the space provided.

Lead Author: Ryota Sagami Email Address*: sagami1985@yahoo.co.jp

No financial relationships with a commercial entity producing health-care related products and/or services relevant to this article.

Company Type of Relationship** Content Area (if applicable)

Author: Hidefumi Nishikiori Email Address*: nikki@san-ai-group.org

No financial relationships with a commercial entity producing health-care related products and/or services relevant to this article.

Company Type of Relationship** Content Area (if applicable)

Author: Takao Sato Email Address*: iwataiwata18@yahoo.co.jp

No financial relationships with a commercial entity producing health-care related products and/or services relevant to this article.

Company Type of Relationship** Content Area (if applicable)

Author: Kazunari Murakami Email Address*: murakam@oita-u.ac.jp

No financial relationships with a commercial entity producing health-care related products and/or services relevant to this article.

Company Type of Relationship** Content Area (if applicable)

Conflict of Interest

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* We will use email addresses only for questions related to this article ** Type of relationship may include: full-time or part-time employee, independent contractor, consultant, research or other grant recipient, paid speaker

or teacher, membership on advisory committee or review panels, ownership interest (product royalty/licensing fees, owning stocks, shares, etc.), relationship of a spouse or partner, or any other financial relationship.

As corresponding author of this article, I attest that I have received disclosure information from all

participating authors as listed above and acknowledge that I am responsible for verifying the accuracy of and

reporting completely the information provided to me. Financial relationships relevant to this article can be

researched at https://www.cms.gov/openpayments/. I understand that typing my name below serves as an

electronic signature for the purposes of this form.

Ryota Sagami Type Name (Electronic Signature)

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