Anesthetic Experience and Patients 'Prognosis of SARS-CoV-2 Positive Versus Negative Burns Patients: An Observational Case -Control Study
Conditions: SARS-CoV-2 Infection
Sponsor: Hamad Medical Corporation

HMC RESEARCH PROTOCOL  
 
 
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Study Title:
Anesthetic Management for Burn Injuries During SARS-
CoV-2 
Local IRB Serial 
number 
MRC-01-20-1074 
Contents 
 
1. Synopsis ........................................................................................................................... 2 
2. Abbreviations and Acronyms ............................................................................................ 2 
3. Introduction / Background ................................................................................................. 3 
4. Objectives ......................................................................................................................... 4 
5. Indicate if this is a retrospective data review ..................................................................... 4 
6. Study Methodology ........................................................................................................... 4 
7. Study Population and Study Setting/ Location .................................................................. 4 
8. Study procedures .............................................................................................................. 5 
Study Duration and Timelines .............................................................................................. 5 
Informed Consent ................................................................................................................ 5 
Risk ...................................................................................................................................... 5 
Bio-Specimens & Sample Collection .................................................................................... 5 
Outcomes............................................................................................................................. 5 
Data Collection, Data Management& Confidentiality ........................................................... 6 
Subject Withdrawal/ Withdrawal of Consent ........................................................................ 6 
9. Statistical Consideration and Data Analysis ...................................................................... 6 
10. 
Adverse Event Reporting ............................................................................................... 7 
11. 
Ethical Consideration ..................................................................................................... 7 
12. 
Sponsor, Funding & Collaborator Information ................................................................ 7 
13. 
Dissemination of Results and Publication policy ............................................................ 7 
14. 
Appendices .................................................................................................................... 7 
15. 
References ................................................................................................................. 7-8 
 
 
 

 
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1. Synopsis 
 
Objective Anesthetic management of burn patients is a real challenge to the 
anesthesiologist. Recently, in the presence of COVID-19 epidemic, we tried to manage 
safely our patients and provide protection for our health care professionals. There is a 
lack of information about Survival of burn patients under these conditions.  
Aim of this work:  
Primary outcome is to investigate survivals, ICU admission and length of hospital stay 
of those critical patients. 
Secondary outcome is to analyses perioperative factors that affected their survival 
outcome. 
 
 
 
 
2. Abbreviations and Acronyms 
Severe acute respiratory syndrome coronavirus-2, (SARS-Cov-2), coronavirus disease 2019, 
COVID-19; American Society of Regional Anaesthesia and Pain Medicine, ASRA; European 
Society of Regional Anaesthesia and Pain Therapy, ESRA 
 
 

 
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3. Introduction / Background 
 
The rapidly spreading severe acute respiratory syndrome coronavirus-2 (SARS-Cov-2) 
the causative agent of coronavirus disease 2019 (COVID-19) epidemic is attacking the 
whole world and exaggerating an economic crisis (1). It is transmitted via contact with 
respiratory droplets that exposes anaesthetists to the risk of viral infection during their 
routine work (2),(3). 
All countries have implemented protective and preventive measures which subjected 
persons to stay longer period at home. A Brazilian study found that spending more time  
in the domestic environment and, consequently, leading to a greater  exposure to 
sanitizer products, which contain ethanol and hydrogen peroxides that can lead to burn 
injuries during the pandemic period of COVID-19 (4),.  
 
Many burn centers have revised their policy during COVID-19 pandemic (5),(6). Burns 
are an acute emergency condition, and burn management needs to be initiated before 
COVID-19 infection status can be confirmed. Our institute already developed an 
algorithm for protection during COVID-19 infection. However, anesthesia management 
is challenge for burn patient particularly if the patient is suspected or diagnosed to be 
positive for corona virus.  
In the era of COVID-19, Both the American Society of Regional Anaesthesia and Pain 
Medicine (ASRA) and the European Society of Regional Anaesthesia and Pain Therapy 
(ESRA) established a joint statement which recommends neuraxial and peripheral 
nerve blocks for patients with COVID-2019 infection and describe  the benefits of 
regional anesthetic and analgesic techniques over general anaesthetics especially in  
patients with underlying metabolic derangements such as burns (7). Those critical 
patients with COVID-19 were subjected to coagulation abnormalities which may affect 
their survivals (8).  
 
Aim of our Study: 
Primary outcome is to investigate survivals, ICU admission and length of hospital stay 
of those critical patients. 
Secondary outcome is to analyses perioperative factors that affected their survival 
outcome. 
 
 
 

 
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4. Objectives 
In this section provide a clear statement of the primary and any secondary objectives of the study 
To investigate survivals, ICU admission and length of hospital stay of those critical 
patients. 
And to analyze perioperative anesthetic factors that affected their primary outcome.  
5. Indicate if this is a retrospective data review 
 
• 
Retrospective Chart/data Review (Retrospective means the data is already in existence 
when the project is submitted to the IRB for initial review. 
 
• Provide the date range of the chart review (if this is a retrospective chart review, the 
end date must come before the submission date April 1, 2020, and November 16, 2020. 
6. Study Methodology 
 
 
Patients who had the burn graft surgery at Al Wakrah Hospital; Hamad Medical Corporation 
between from April 1, 2020, and November 16, 2020. Planned sample size will include all 
COVID-19 positive and negative cases. Our institution as Al Wakrah Hospital is the ONLY 
center at HMC which deals with those unique Burn patients allover Qatar. By increasing 
sample size, we can get our expected results statistically.  
 
Data Source 
The electronic medical record (Cerner) used in order to identify patients who match study 
defined criteria. We can Collect data directly from Cerner to excel sheet  
 
Variable Abstraction    
Patient demographic and clinical data will be collected including age, morbidities, presenting 
symptoms, physical examination, laboratory investigations, intraoperative data, type of surgery, 
postoperative course, survival, and length of hospital stay and follow up. 
 
In addition, the type of anesthesia is also included as factor for further complications ex general 
anesthesia, spinal or combined spinal epidural type. 
 
Retrospective full reviewing of their medical illness and chart laboratory and investigations will 
be collected after getting approval of MRC and IRB committee.  
 
 
 
7. Study Population and Study Setting/ Location 
 
All adult patients who had undergone burn graft surgery at Al Wakrah (AWH) Hospital; 
Hamad Medical Corporation between April 1, 2020, and November 16, 2020. We will 
include all Consecutive Adult patient underwent burn grafting surgery at AWH either 
 

 
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they are COVID positive or negative.  
 
8. Study procedures 
Provide an outline and describe in detail the processes and operations of the study, including logistics 
Study Duration and Timelines 
Expected duration of the study& start times, stages of the study such as screening, treatment phase, visit 
numbers, etc 
6 months data collection & another 6 months writing manuscript and trial to submission 
to a suitable journal 
Informed Consent 
Informed Consent will be waived for such a retrospective analysis. 
Risk 
This study has no physical, psychological, economic or societal harms that may befall a 
subject as a result of their data being included in this study. 
Bio-Specimens & Sample Collection 
 
Not applicable 
Outcomes 
Primary outcome is to investigate survivals, ICU admission and length of hospital stay 
of those critical patients. 
Secondary outcome is to analyses perioperative anesthetic factors that affected their 
primary outcome.  

 
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Data Collection, Management&Confidentiality 
a) Indicate below HOW study data will be collected for the proposed research. 
 
 Study Forms    
 Study Database     
 Study Web-Based/App    
 Other      
 
Please detail how study data will be coded: 
 
Special encryption codes will be used to separate research data from subject 
identifiers and the data will be dealt with privacy and confidentiality. Each patient will 
be assigned a random code and any information relating to the patient will now only 
be related to the patient by the random code and not by their name or health card 
number.Then any link to the actual record will be destroyed after data collection is 
completed. The anonymized data set will be kept for at least 5 years after study 
completion. Data will be collected in excel format. 
 
b) Describe below WHERE and HOW the study data is physically stored. 
 
Primary investigator will store the electronic data on a password protected computer 
which is secured by a firewall. Data collection form will be kept in a safe cabinet. The 
anonymized data set will be kept for at least 5 years after study completion.  
 
kept in a safe cabinet 
 
 
c) Describe below WHO controls access to the study data 
 
PI 
 
d) Describe below WHO has access to the study data. 
 
PI 
 
e) Describe below HOW the study data is accessed. 
 
The lead PI will have the control over the access to study data through password 
secured computers. 
 
f) Will subject identifiers be shared outside of HMC? If YES describe below WHOM the study data is 
shared 
 
No 
 
 
Subject Withdrawal/ Withdrawal of Consent 
Not applicable 
 
 
9. Statistical Consideration and Data Analysis 
 
Descriptive statistics will be used to summarize all demographic, clinical, laboratory 
 
 

 
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tests, intraoperative data, postoperative course and outcomes. The normally distributed 
data and results will be reported with mean and standard deviation (SD); the remaining 
results will be reported with median and interquartile range (IQR). Categorical data will 
be summarized using frequencies and percentages.  
 
Survival can be performed using Kaplan Meir Curve; risk factors can be identified by 
using Univariate Analysis and Multivariate Logistic Regression Analysis. 
 
All P values presented will be two-tailed, and P values <0.05 will be considered as 
statistically significant. All Statistical analyses will be done using statistical packages 
SPSS 22.0 (SPSS Inc. Chicago, IL) and Epi-info (Centers for Disease Control and 
Prevention, Atlanta, GA) software. 
10. Adverse Event Reporting 
No adverse events are expected. 
 
 
11. Ethical Consideration 
The study will be conducted in full conformance with principles of the “Declaration of Helsinki”, Good 
Clinical Practice (GCP) and within the laws and regulations of MoPH in Qatar. 
 
 
12. Sponsor, Funding & Collaborator Information 
Funding is needed for publication this research. 
 
13. Dissemination of Results and Publication policy 
After finish data collection, may be 3-4 months to finalize the statistics and writing the 
manuscript to submit in a suitable anesthesia journal after MRC approval. 
 
 
 
 
 
 
14. Appendices 
List in this section all intended forms or resources that will be used in the conduct of research to collect 
data, interview people, recruit participants. 
Protocol. + Research information-DCF 
 
15. References: 
 
1. Wong J, Goh QY, Tan Z, Lie SA, Tay YC, Ng SY, et al. Preparing for a COVID-19 
pandemic: a review of operating room outbreak response measures in a 
large tertiary hospital in Singapore. Can J Anaesth. 2020 Jun;67(6):732-45. 

 
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2. Plaat F, Campbell JP. Is spinal anaesthesia an aerosol-generating 
procedure? Transmission of SARS-CoV-2 from patient to anaesthetist. Br J 
Anaesth. 2020 Sep;125(3):e315. 
3. Zhong Q, Liu YY, Luo Q, Zou YF, Jiang HX, Li H, et al. Spinal anaesthesia for 
patients with coronavirus disease 2019 and possible transmission rates in 
anaesthetists: retrospective, single-centre, observational cohort study. Br J 
Anaesth. 2020 Jun;124(6):670-5. 
4. Valente TM, Ferreira LPS, Silva RAD, Leite J, Tiraboschi FA, Barboza MCC. 
Brazil Covid-19: Change of hospitalizations and deaths due to burn injury? 
Burns. 2020 Oct 17. 
5. Barret JP, Chong SJ, Depetris N, Fisher MD, Luo G, Moiemen N, et al. Burn 
center function during the COVID-19 pandemic: An international multi-
center report of strategy and experience. Burns. 2020 Aug;46(5):1021-35. 
6. Young AW, Graves C, Kowalske KJ, Perry DA, Ryan CM, Sheridan RL, et al. 
Guideline for Burn Care Under Austere Conditions: Special Care Topics. J 
Burn Care Res. 2020 Mar/Apr;38(2):e497-e509. 
7. Uppal V, Sondekoppam RV, Landau R, El-Boghdadly K, Narouze S, Kalagara 
HKP. Neuraxial anaesthesia and peripheral nerve blocks during the COVID-
19 pandemic: a literature review and practice recommendations. 
Anaesthesia. 2020 Oct;75(10):1350-63. 
8. Tang N, Li D, Wang X, Sun Z. Abnormal coagulation parameters are 
associated with poor prognosis in patients with novel coronavirus 
pneumonia. J Thromb Haemost. 2020 Apr;18(4):844-7.