Taiwan "Aerosol Box" Versus UMMC "Intubation Box" : Clinical Evaluation of the "Intubation Box" for Ease of Intubation
Phase: NA
Conditions: COVID-19, Airway
Sponsor: University of Malaya

 
 
 
 
 
Taiwan “Aerosol Box” versus UMMC “Intubation 
Box” : Clinical Evaluation Of The “Intubation Box” 
For Ease Of Intubation 
 
 
 
 
INVESTIGATOR : 
DR. SHAIRIL RAHAYU BINTI RUSLAN 
 
CO-INVESTIGATOR : 
ASSOC. PROF. DR. INA ISMIARTI BINTI SHARIFFUDDIN 
ASSOC. PROF. DR. CHAW SOOK HUI 
ASSOC. PROF. DR. LOH PUI SAN 
DR. NOORJAHAN HANEEM BINTI MD HASHIM 
DR. MOHD FITRY BIN ZAINAL ABIDIN 
DR. NURAZREEN BINTI HUSSAIN 
DR. MOHD AFIQ SYAHMI BIN RAMLI 
 
 
DEPARTMENT OF ANAESTHESIOLOGY 
UNIVERSITY MALAYA MEDICAL CENTRE 
 
 
 
 
 
1st MAY – 31st DECEMBER 2020 
Version 1.0 10/04/2020 
 
 
 
 
 
 
 
 
 
 
 

Taiwan “Aerosol Box” versus UMMC “Intubation Box” : Clinical evaluation of the 
“Intubation Box” for ease of intubation  
 
Background: 
 
Intubation is classified as an aerosol-generating procedure (AGP). Intubation in a 
confirmed COVID-19 patient with a high viral load poses a high risk of exposure to health care 
workers (HCW). To reduce this risk, the HCW and their assistants are advised to don full 
personnel protective equipment (PPE) with a powered air purifying respiratory (PAPR) during 
intubation. In view of this concern, this procedure is highly recommended to be done in a 
negative pressure room to control the spread of aerosolizing particles in the room. A first-pass 
success in intubation is also crucial to minimize the risk of infection to health care workers 
involved. 
 
Introduction : 
 
An Aerosol Box (from here on known as Box A) was recently designed by Dr. Lai 
Hsien Yung from Taiwan which adds extra protection to the intubator and the surrounding 
environment (Everington, 2020). The Aerosol Box is a transparent box made of acrylic or 
transparent polycarbonate sheet, designed with an opening on one side allowing it to fit 
over the patient's chest and neck, while the opposing side has two holes through which 
the intubator can insert their hands through (Figure 1). It was shown that this barrier 
enclosure during intubation protects the laryngoscopist. Canelli et al simulated a patient with a 
cough during intubation with and without the Aerosol Box. With the box, they showed that the 
simulated cough resulted in contamination of only the inner surface of the box, the 
laryngoscopist’s gloves and gowned forearms. Examination of the laryngoscopist and the room 
with ultraviolet light after the simulated cough also showed no macroscopic contamination 
outside the box. . In contrast, intubation without the box demonstrated that the laryngoscopist’s 
gown, gloves, face mask, eye shield, hair, neck, ears, and shoes were all contaminated.  
 
Feedbacks from our colleagues stated that intubation with Box A is slightly difficult 
and may cause delay in intubation. Canelli et al also concluded this observation. We, therefore, 
innovated the design of Box A to facilitate the laryngoscopist, as shown in Figure 2 
(“Intubation Box”, from here on known as Box B). We find that Box B has better ergonomics, 
and this will increase the rate of success of intubation.  
Objectives : 
 

We aim to compare the relative intubating efficacies of these two boxes. This study 
assesses the time to successful intubation as the primary outcome. Our secondary outcomes 
will be the quality of the laryngoscopy view (objectively defined as “percentage of glottic 
opening” / POGO) and ease of intubation. 
 
Methodology: 
 
This is a prospective randomized cross over trial to compare the time for intubation 
using these two devices by our anaesthetists. The planned duration from planning to 
recruitment to completion of study will be from 1st May 2020 to 31st December 2020. We will 
recruit eligible anaesthetists after obtaining written informed consent. The anaesthetist should 
have more than 5 years of experience with intubation as well as experience with intubating 
patients using videolaryngoscope for more than 20 times. 
 
The anaesthetist will be randomised  to intubate the manikin in either Box A or Box B 
first. The primary endpoint which is the time to successful intubation (defined as the interval 
from insertion of the laryngoscope blade into the mouth to inflation of the tracheal tube cuff) 
will be recorded. Other endpoints are the numbers of intubation attempts (each attempt defined 
as complete removal of video laryngoscope from mouth and reinsertion) will be recorded. 
Failed insertion is defined as the entire intubation procedure taking more than 120 seconds or 
more than 3 insertion attempts.  
 
The participants will evaluate their intubation experience using both boxes with a 
questionnaire based on the ISO9421-11 standard, that is effectiveness, efficiency and 
satisfaction. 
 
Sample size: 
 
The primary endpoint of the study is time to successful tracheal intubation. Sample size 
is based on a calculation of 10.0 s as the clinically relevant difference in intubation time, with 
a  prospective power analysis at 80% power and 0.05 level of significance. It  shows that a 
sample of 28 laryngoscopists would be required.  This will be a cross over study, hence we will 
recruit 30 laryngoscopists to also account for dropouts and protocol breaches. In view that the 
time to successful intubations data are not normally distributed, we will use the Mann Whitney 
U test to analyse intubation times. Categorical data such as number of intubation attempts will 
be evaluated for differences among the groups using the chi-square test. All statistical analyses 

will be performed using IBM SPSS statistics 23 database. A value of p < 0.05 is considered 
significant. 
     
 
Figure 1 (Box A). Dimensions are 50 cm by 50 cm (height x width),  
with a thickness of 40 cm. (Source : https://sites.google.com/view/aerosolbox/design) 
 
   
 
 
Figure 2 (Box B). Dimensions are 46 cm x 58 cm (height x width) with a thickness of 51cm. 
The upper portion of the box facing the intubator is made slanted at a 150 degree angle hence 
providing better ergonomics to the intubator. The curved design at one end of the box is to 
accommodate the obese/big build patient whose shoulder breadth may be wider than the 
box’s width. 
 
 
References : 
1. Everington K. “Taiwanese doctor invents device to protect US doctors against 
coronavirus”. Taiwan News, 23rd March 2020, 
https://www.taiwannews.com.tw/en/news/3902435 
2. Canelli R., Connor C.W., Gonzalez M., et al. (2020)  “Barrier enclosure during 
endotracheal intubation”. New England Journal of Medicine. 3rd April 2020. DOI: 
10.1056/NEJMc2007589. 
 
 
 

FLOW CHART 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Analysis of data 
Anaesthetists who have : 
1) More than 5 years experience in 
intubation, AND; 
2) Used the videolaryngoscope successfully 
to intubate airways for more than 20 
ti
Written informed consent 
Group 1 
Intubation of manikin with 
Box A 
Group 2 
Intubation of manikin with 
Box B 
Intubation of manikin with 
Box B 
Intubation of manikin with 
Box A 
Collection of data using 
questionnaire 
Participant will be randomized to 
either Group 1 or Group 2 

GANTT CHART OF RESEARCH ACTIVITIES 
PROJECT TITLE : TAIWAN “AEROSOL BOX” VERSUS UMMC “INTUBATION BOX” :  
CLINICAL EVALUATION OF THE “INTUBATION BOX” FOR EASE OF INTUBATION 
 
 
 
YEAR 2020 
Apr 
1-15 
Apr 
16-30 
May 
1-15 
May 
16-31 
June 
1-15 
June 
16-30 
Jul 
1-15 
Jul 
16-31 
Aug 
1-15 
Aug 
16-31 
Sept 
1-15 
Sept  
16-30 
Oct 
1-15 
Oct  
16-31 
Nov  
1-15 
Nov  
16-30 
Dec  
1-15 
Dec  
16-30 
ACTIVITIES 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Submission for ethics  
committee approval 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Preparation of resources  
required 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Data collection 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Data entry 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Data analysis 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Writing of report 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Submission of completed paper to 
ISI journal 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

MILESTONES AND DATES CHART 
PROJECT TITLE : TAIWAN “AEROSOL BOX” VERSUS UMMC “INTUBATION BOX” :  
CLINICAL EVALUATION OF THE “INTUBATION BOX” FOR EASE OF INTUBATION 
 
 
YEAR 2020 
Apr 
1-
15 
Apr 
16-
30 
Ma
y 
1-
15 
May 
16-
31 
June 
1-15 
June 
16-
30 
Jul 
1-
15 
Jul 
16-
31 
Aug 
1-
15 
Aug 
16-
31 
Sept 
1-
15 
Sept  
16-
30 
Oct 
1-
15 
Oct  
16-
31 
Nov  
1-
15 
Nov  
16-
30 
Dec  
1-
15 
Dec  
16-30 
ACTIVITIES 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Submission for ethics  
committee approval 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Preparation of resources  
required 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Data collection 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Data entry 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Data analysis 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Writing of report 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Submission of completed paper 
to ISI journal 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

 
 
Data collection sheet 
 
Part 1: User profile 
 
Name: 
 
Professional category: 
 
Anaesthesia experience: 
 
Age: 
 
Gender: 
 
Part 2: Intubating conditions profile 
 
For direct laryngoscopy: 
 
Findings 
Taiwan Box 
UMMC Box 
Time for successful intubation 
(seconds) 
 
 
Number of intubation attempts 
 
 
 
POGO grading (%) 
 
 
 
Cormack Lehane grade (1-4) 
 
 
 
 
For videolaryngoscopy: 
 
Findings 
Taiwan Box 
UMMC Box 
Time for successful intubation 
(seconds) 
 
 
Number of intubation attempts 
 
 
 
POGO grading (%) 
 
 
 
Cormack Lehane grade (1-4) 
 
 
 
 
Part 3: Usability profile 
In this section, we would like to know the usability of this equipment (Taiwan Box vs UMMC Box) 
during intubation.  
 
When using for intubation with direct laryngoscopy:  
Findings 
Taiwan Box 
UMMC Box 
On a scale of 0-
10, how easy was 
it to use this box? 
 
0                                               10 
Very difficult 
         Very easy 
 
0                                                10 
Very difficult 
         Very easy 
 
Please choose 
your level of 
agreement with 
the statements 
below. 
Degree of agreement: 
1: 
Strongly 
disagree 
2: 
Disagree 
3: 
Agree 
4: 
Strongly 
agree 
1: 
Strongly 
disagree 
2: 
Disagree 
3: Agree 
4: 
Strongly 
agree 
It is comfortable 
for me to use 
 
 
 
 
 
 
 
 

this equipment 
My visual field is 
clear while using 
this equipment 
 
 
 
 
 
 
 
 
My hand 
movements were 
free while using 
this equipment 
 
 
 
 
 
 
 
 
 
When using for intubation with videolaryngoscopy :  
Findings 
Taiwan Box 
UMMC Box 
On a scale of 
0-10, how 
easy was it to 
use this box? 
 
0                                               10 
Very difficult 
         Very easy 
 
0                                                10 
Very difficult 
         Very easy 
 
Please 
choose your 
level of 
agreement 
with the 
statements 
below. 
Degree of agreement: 
1: 
Strongly 
disagree 
2: 
Disagree 
3: Agree 
4: 
Strongly 
agree 
1: 
Strongly 
disagree 
2: 
Disagree 
3: Agree 
4: 
Strongly 
agree 
It is 
comfortable 
for me to use 
this 
equipment 
 
 
 
 
 
 
 
 
My visual 
field is clear 
while using 
this 
equipment 
 
 
 
 
 
 
 
 
My hand 
movements 
were free 
while using 
this 
equipment 
 
 
 
 
 
 
 
 
 
Which box would you prefer to use? 
 
__________________________________________________________________________________
__________________________________________________________________________________
__________________________________________________________________________________ 
Do you have any suggestions on how we can improve this equipment? 
__________________________________________________________________________________
__________________________________________________________________________________
__________________________________________________________________________________ 
 
 
 
 
 
 

 
APPENDIX A 
 
“PERCENTAGE OF GLOTTIC OPENING” VIEW (POGO) 
 
The percentage of glottic opening (POGO) score for laryngeal grading. The POGO score 
represents the linear span from the anterior commissure to the interarytenoid notch. 
(source : “Laryngeal Exposure (Opening) Scores” https://www.e4ent.com/articles/laryngeal-
exposure-opening-scores/) 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

APPENDIX B 
CONSENT BY PARTICIPANT FOR CLINICAL RESEARCH       
 
Version No.: 1.0 
  
Version Date: 10/04/2020 
  
 
 
I, …………………………………………………………………….    
Identity Card No……….………………………………… 
                              (Name of Participant) 
of ……………………………………………………………………………………………………………………………………... 
(Address) 
hereby agree to take part in the clinical research (clinical study/questionnaire study/drug trial) specified below:  
 
Title of Study:   Taiwan Aerosol Box versus UMMC Intubation Box : Clinical Evaluation Of The “Intubation 
Box” For Ease Of Intubation 
 
the nature and purpose of which has been explained to me by 
Dr. ..………….………………………….………………                                                                                                         
                 (Name & Designation of Doctor) 
 
and interpreted by ………………………..……………………………….…..………… 
                                         (Name & Designation of Interpreter) 
 
……………………………………….. to the best of his/her ability in …………………….…………… language/dialect. 
 
I have been told about the nature of the clinical research in terms of methodology, possible adverse effects and 
complications (as per participant information sheet).  After knowing and understanding all the possible 
advantages and disadvantages of this clinical research, I voluntarily consent of my own free will to participate 
in the clinical research specified above. 
 
I understand that I can withdraw from this clinical research at any time without assigning any reason whatsoever 
and in such a situation shall not be denied the benefits of usual treatment by the attending doctors. 
 
Date: ……………...………..                          Signature or Thumbprint …………….…………………………… 
                                                                                                                         (Participant) 
IN THE PRESENCE OF 
 
Name ………………………………………..….……..…) 
                                                                                ) 
Identity Card No. ………………………….…….…… )                                   Signature             
 
                                                                                              (Witness for Signature of Participant) 
Designation ……………………………….……………)  
 
I confirm that I have explained to the participant the nature and purpose of the above-mentioned clinical 
research. 
 
Date …………………………….                                              Signature …………………………………………………… 
                                                                                                              (Attending Doctor) 
                                                                   
 
CONSENT BY PARTICIPANT           R.N.                                                                    
                  FOR                                Name 
  CLINICAL RESEARCH                    Sex 
                                                           Age 
                                                                              Unit                                                                          BK-MIS-
1117-E02 
   
 
 
 

CONSENT BY RESPONSIBLE RELATIVE FOR CLINICAL RESEARCH    
     
Version No.: 1.0 
  
Version Date: 10/04/2020 
  
 
 
I, …………………………………………………………………….   
Identity Card No…………...……………………………   
                                                   (Name) 
of …………………………………………………………………………………………………………………………………… 
                                                                     (Address) 
 
hereby agree that my relative ……………………………………………………..  
I.C. No………..……………………… 
                                                                         (Name) 
participate in the clinical research (clinical study/questionnaire study/drug trial) specified below:-  
Title of Study:   Taiwan Aerosol Box versus UMMC Intubation Box : Clinical Evaluation Of The 
“Intubation Box” For Ease Of Intubation 
the nature and purpose of which has been explained to me by Dr...………….………………………….……………      
(Name & Designation of Doctor) 
 
and interpreted by ………………………..……………………………….…..………… 
                                        (Name & Designation of Interpreter) 
 
…………………………………… to the best of his/her ability in …………………….…………… language/dialect. 
 
I have been informed of the nature of this clinical research in terms of procedure, possible adverse effects and 
complications (as per patient information sheet).  I understand the possible advantages and disadvantages of 
participating in this research.  I voluntarily give my consent for my relative to participate in this research 
specified above. 
 
I understand that I can withdraw my relative from this clinical research at any time without assigning any 
reason whatsoever and in such situation, my relative shall not be denied the benefits of usual treatment by 
the attending doctors.  Should my relative regains his/her ability to consent, he/she will have the right to 
remain in this research or may choose to withdraw. 
 
                                                 Relationship                            Signature or 
Date: ……………………..           to Participant …………………   Thumbprint                    …………………… 
                                                                                                             
IN  THE  PRESENCE  OF        
 
Name …………………………………………….…..) 
                                                                           ) 
Identity Card No. …………………………………. )                     Signature ……………………………………………… 
                                                                           )                                                          (Witness) 
Designation …………………………………………)  
 
I confirm that I have explained to the patient’s relative the nature and purpose of the above-mentioned 
clinical research. 
 
Date …………………………….                                                               
Signature ……………………………………………………………… 
                                                                                                       (Attending Doctor) 
                                                                   
                                                             R.N.                                                            
                CONSENT BY                       Name 
 RESPONSIBLE RELATIVE FOR           Sex 
         CLINICAL RESEARCH                Age                                                                                   BK-MIS-
1117-E02 
                                                              Unit            
 
 
 
 

PARTICIPANT INFORMATION SHEET 
 
Study Title: Taiwan “Aerosol Box” versus UMMC “Intubation Box” : Clinical 
Evaluation Of The “Intubation Box” For Ease Of Intubation 
 
Version No: 1.0 
Version Date: 10/04/2020 
 
We would like to invite you to take part in a research study. Before you decide 
whether to participate, you need to understand why the research is being done 
and what it would involve. Please take time to read the following information 
carefully; talk to others about the study if you wish. 
 
Ask us if there is anything that is not clear or if you would like more information. 
Take time to decide whether or not you wish to take part.  
 
 
1. 
What is the purpose of this study? 
The UMMC “Intubation Box” is an innovation to the open-source Aerosol 
Box design that was released recently as a protective device used to 
minimize aerosolization of contaminant from the patient’s airway during 
airway manipulation and intubation. The UMMC “Intubation Box” is 
designed with better ergonomics and is more user-friendly which is aimed 
to increase the rate of successful intubation as well as reducing the time 
needed to intubate the airway. 
 
2. 
Why is this study important? 
We hope to gain evidence that the UMMC “Intubation Box” is indeed a 
superior design that allows for increased rates of successful intubation 
within a shorter duration of time. 
 
3. 
What type of study is this? 
This is a prospective randomized cross-over trial that involves the usage  
and analysis of a medical device. 
 
4. 
What is the procedure that is being tested? (If applicable) 
We will observe and record the time taken for successful intubation of 
airway manikin using both the Taiwan “Aerosol Box” and UMMC “Intubation 
Box”. 
 
5. 
Does 
the 
investigatory 
product 
contain 
cultural 
sensitive 
ingredients eg: bovine or porcine? (if applicable) 
No. 
 
6. 
Why have I been invited to participate in this study? 
You are invite to participate as you would be an anaesthetist who have had 
experience in intubation for at least 5 years and experience with using 
videolaryngoscopy for more than at least 20 times. 
 
7. 
Who should not participate in the study? 
Anaesthetists with less than 5 years experience in intubating airways. 
 
8. 
Can I refuse to take part in the study? 
You have the right to refuse as well as the right to withdraw from the study 
at any time. 
 

9. 
What will happen to me if I take part?  
You will be given a set of questionnaires asking details regarding your 
demographics and experience in intubating airways, as well as a post-
study survey assessing your findings and views after using the two 
different boxes. 
 
10. 
How long will I be involved in this study? 
You will spend about an hour with us for the practical aspect of data 
collection.  
 
11. 
What are the possible disadvantages and risks? 
As this study will only involve the participants intubating manikins, there 
are no obvious risks to be seen. No human or animals will be used directly 
to demonstrate the intubating conditions. 
 
12. 
What are the possible benefits to me? 
You will have experience intubating with two different boxes and 
participate in a continuous quality improvement session which aims to 
optimize intubating conditions for anaesthetists on a national level in view 
of the current COVID-19 pandemic. 
 
13. 
Who will have access to my medical records and research data? 
The result of the data obtained will be reported in a collective manner with 
no reference to a specific individual. 
 
14. 
Will my records/data be kept confidential? 
Your records/data will be kept confidential. 
 
15. 
What will happen to any samples I give? (If applicable) 
Not applicable. 
 
16. 
What will happen if I don’t want to carry on with the study? 
The participation in this study is voluntary. If you prefer not to take part, 
your decision will be respected and it will not be questioned. 
 
17. 
What if relevant new information about the procedure/ drug/ 
intervention becomes available? (If applicable) 
It would not affect the data that we collected from you and you would not 
be required to return for a repeat session. 
 
18. 
What happens when the research study stops? (If applicable) 
Not applicable. 
 
19. 
What will happen to the results of the research study? 
The results of the study will be used to make further improvements to the 
intubation box as well as collated and analyzed and submitted as a 
manuscript to an appropriate ISI journal for publication. 
 
20. 
Will I receive compensation for participating in this study? 
No compensation is available to you for participating in this study. 
 
21. 
Who funds this study? 
This study is self-funded. 
 
22. 
Who should I contact if I have additional questions/problems 
during the course of the study? 
 

Name of investigator 1 : DR SHAIRIL RAHAYU BINTI RUSLAN 
Affiliation : DEPARTMENT OF ANAESTHESIOLOGY 
Telephone number (Mobile number) : 012-3291074 
 
Name of investigator 2 : DR. MOHD FITRY BIN ZAINAL ABIDIN 
Affiliation : DEPARTMENT OF ANAESTHESIOLOGY 
Telephone number (Mobile number) : 019-3354708 
 
 
23. 
Who should I contact if I am unhappy with how the study is being 
conducted? 
 
Medical Research Ethics Committee 
University of Malaya Medical Centre 
Telephone number: 03-7949 3209/2251