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The aim of this study is to compare the impact of using the aerosol box and transparent sheet as an adjunct to conventional personal protective equipment on endotracheal intubation of COVID-19 patients. The effect of the head of the bed elevation will also be evaluated during the mentioned simulated scenarios.
This is a randomized, prospective, manikin simulation study. Emergency medicine specialists will be participated in the study. Participants will be randomly assigned into 6 groups with a 1:1:1:1:1:1 allocation following simple randomization procedures by a program generating online random numbers. 13 participants will be recruited to the study.
Operators who will intubate the manikin will use following methods: (1) conventional personal protective equipment (PPE) with placing the manikin in the supine position. (2) aerosol box as an adjunct to PPE with placing the manikin in the supine position. (3) transparent sheet as an adjunct to PPE with placing the manikin in the supine position. (4) conventional personal protective equipment (PPE) with placing the manikin in the 30 degree the head of the bed elevated position. (5) aerosol box as an adjunct to PPE with placing the manikin in the 30 degree the head of the bed elevated position. (6) transparent sheet as an adjunct to PPE with placing the manikin in the 30 degree the head of the bed elevated position.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| aerosol box | Device | The aerosol box is a barrier that protects the staff against the aerosols during the aerosol generating procedures like endotracheal intubation. It is a transparent cube that covers the patient's head during the endotracheal intubation. Operator can intubate the patient through the two holes for arms. | ||
| transparent sheet | Device | The transparent sheet is a barrier that protects the staff against the aerosols during the aerosol generating procedures like endotracheal intubation. It is a transparent cover that covers the patient's head and body during the endotracheal intubation. Operator can intubate the patient through the space under the cover |
| Measure | Description | Time Frame |
|---|---|---|
| First pass success | Comparison of the first pass success rates for each method that were mentioned in the 'Detailed Description' of the study. | 2 minutes |
| Measure | Description | Time Frame |
|---|---|---|
| Time to endotracheal intubation | The mean time to successful endotracheal intubation for each method that were mentioned in the 'Detailed Description' of the study. | 2 minutes |
| Difficulty level of accessing the equipment |
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Inclusion Criteria:
Exclusion Criteria:
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The study population includes emergency medicine specialists who wants to participate to the study.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kocaeli Derince Training and Research Hospital | Kocaeli | Izmit | 41900 | Turkey (Türkiye) |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32171076 | Background | Zhou F, Yu T, Du R, Fan G, Liu Y, Liu Z, Xiang J, Wang Y, Song B, Gu X, Guan L, Wei Y, Li H, Wu X, Xu J, Tu S, Zhang Y, Chen H, Cao B. Clinical course and risk factors for mortality of adult inpatients with COVID-19 in Wuhan, China: a retrospective cohort study. Lancet. 2020 Mar 28;395(10229):1054-1062. doi: 10.1016/S0140-6736(20)30566-3. Epub 2020 Mar 11. | |
| 32250385 |
| Label | URL |
|---|---|
| Aerosol Box | View source |
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| ID | Term |
|---|---|
| D000086382 | COVID-19 |
| ID | Term |
|---|---|
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
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Grading the difficulty of accessing the equipment on a 5-point Likert scale for each method that were mentioned in the 'Detailed Description' of the study.
| 2 minutes |
| Difficulty level of inserting the endotracheal tube into the glottis | Grading the difficulty of inserting the endotracheal tube into the glottis on a 5-point Likert scale for each method that were mentioned in the 'Detailed Description' of the study. | 2 minutes |
| Clarity of the view of the patient's face | Grading the clarity of the view of the patient's face on a 5-point Likert scale for each method that were mentioned in the 'Detailed Description' of the study. | 2 minutes |
| Grasselli G, Zangrillo A, Zanella A, Antonelli M, Cabrini L, Castelli A, Cereda D, Coluccello A, Foti G, Fumagalli R, Iotti G, Latronico N, Lorini L, Merler S, Natalini G, Piatti A, Ranieri MV, Scandroglio AM, Storti E, Cecconi M, Pesenti A; COVID-19 Lombardy ICU Network. Baseline Characteristics and Outcomes of 1591 Patients Infected With SARS-CoV-2 Admitted to ICUs of the Lombardy Region, Italy. JAMA. 2020 Apr 28;323(16):1574-1581. doi: 10.1001/jama.2020.5394. |
| 22563403 | Background | Tran K, Cimon K, Severn M, Pessoa-Silva CL, Conly J. Aerosol generating procedures and risk of transmission of acute respiratory infections to healthcare workers: a systematic review. PLoS One. 2012;7(4):e35797. doi: 10.1371/journal.pone.0035797. Epub 2012 Apr 26. |
| 32338711 | Background | Feldman O, Meir M, Shavit D, Idelman R, Shavit I. Exposure to a Surrogate Measure of Contamination From Simulated Patients by Emergency Department Personnel Wearing Personal Protective Equipment. JAMA. 2020 May 26;323(20):2091-2093. doi: 10.1001/jama.2020.6633. |
| D014777 |
| Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |