Effect of Using Barrier Devices for Intubation in COVID-19 Patients

COVID-19 Clinical Trial

Official title:

Effect of Using Barrier Devices for Intubation in COVID-19 Patients: Randomized, Prospective, Manikin Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04412226
• Other study ID #: 2020/56
• Status: Completed
• Start date: June 10, 2020
• Est. completion date: June 30, 2020

Study information

• Verified date: December 2020
• Source: Derince Training and Research Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 13
• Est. completion date: June 30, 2020
• Est. primary completion date: June 30, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Participants who want to participate the study

Exclusion Criteria:

• Participants who do not want to participate the study

Related Conditions & MeSH terms

• COVID-19
• Intubation, Intratracheal

Intervention

Device:
• aerosol box
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
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

Locations

Country	Name	City	State
Turkey	Kocaeli Derince Training and Research Hospital	Kocaeli	Izmit

Sponsors (1)

Lead Sponsor	Collaborator
Derince Training and Research Hospital

Country where clinical trial is conducted

Turkey, 

References & Publications (4)

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. — View Citation

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. — View Citation

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. Review. — View Citation

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. Erratum in: Lancet. 2020 Mar 28;395(10229):1038. Lancet. 2020 Mar 28;395(10229):1038. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Secondary	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
Secondary	Difficulty level of accessing the equipment	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
Secondary	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
Secondary	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

External Links

•   Aerosol Box