FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2020/05/025433 [Registered on: 29/05/2020] Trial Registered Prospectively
Last Modified On: 25/07/2021
Post Graduate Thesis  No 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Other 
Public Title of Study   Respiratory emergencies during the COVID-19 Pandemic. 
Scientific Title of Study   A Clinico-epidemiological study of respiratory emergencies treated at the emergency department during the COVID-19 pandemic in a tertiary care center in Karnataka. 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Freston Marc Sirur 
Designation  Assistant Professor 
Affiliation  Kasturba Medical College 
Address  Department of Emergency Medicine, Kasturba Medical College, Manipal

Udupi
KARNATAKA
576104
India 
Phone  9604200840  
Fax    
Email  sirur.freston@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Vivek Gopinathan 
Designation  Associate Professor 
Affiliation  Kasturba Medical College 
Address  Department of Emergency Medicine, Kasturba Medical College, Manipal

Udupi
KARNATAKA
576104
India 
Phone  9447704419  
Fax    
Email  vivgopi@yahoo.com  
 
Details of Contact Person
Public Query
 
Name  Freston Marc Sirur 
Designation  Assistant Professor 
Affiliation  Kasturba Medical College 
Address  Department of Emergency Medicine, Kasturba Medical College, Manipal

Udupi
KARNATAKA
576104
India 
Phone  9604200840  
Fax    
Email  sirur.freston@gmail.com  
 
Source of Monetary or Material Support  
Kasturba Medical College, Madhavnagar,Manipal,Karnataka-576104 
 
Primary Sponsor  
Name  DrFreston Marc Sirur 
Address  Department of Emergency Medicine, Manipal, Karnataka-576104 
Type of Sponsor  Other [self] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
freston marc sirur  Kasturba Hospital, Kasturba Medical College  Emergency Medicine office,Department of Emergency Medicine
Udupi
KARNATAKA 
9604200840

sirur.freston@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
KMC and KH Institutional Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: J680||Bronchitis and pneumonitis due tochemicals, gases, fumes and vapors, (2) ICD-10 Condition: I633||Cerebral infarction due to thrombosis of cerebral arteries, (3) ICD-10 Condition: J441||Chronic obstructive pulmonary disease with (acute) exacerbation, (4) ICD-10 Condition: J440||Chronic obstructive pulmonary disease with acute lower respiratory infection, (5) ICD-10 Condition: B972||Coronavirus as the cause of diseases classified elsewhere, (6) ICD-10 Condition: S070||Crushing injury of face, (7) ICD-10 Condition: G35-G37||Demyelinating diseases of the central nervous system, (8) ICD-10 Condition: S062||Diffuse traumatic brain injury, (9) ICD-10 Condition: D50-D89||Diseases of the blood and blood-forming organs and certain disorders involving the immune mechanism, (10) ICD-10 Condition: L00-L99||Diseases of the skin and subcutaneous tissue, (11) ICD-10 Condition: I850||Esophageal varices, (12) ICD-10 Condition: K74||Fibrosis and cirrhosis of liver, (13) ICD-10 Condition: S028||Fractures of other specified skulland facial bones, (14) ICD-10 Condition: I161||Hypertensive emergency, (15) ICD-10 Condition: I130||Hypertensive heart and chronic kidney disease with heart failure and stage 1 through stage 4 chronic kidney disease, or unspecified chronic kidney disease, (16) ICD-10 Condition: J09-J18||Influenza and pneumonia, (17) ICD-10 Condition: S00-T88||Injury, poisoning and certain other consequences of external causes, (18) ICD-10 Condition: I408||Other acute myocarditis, (19) ICD-10 Condition: B998||Other infectious disease, (20) ICD-10 Condition: J688||Other respiratory conditions due to chemicals, gases, fumes and vapors, (21) ICD-10 Condition: J681||Pulmonary edema due to chemicals,gases, fumes and vapors, (22) ICD-10 Condition: I260||Pulmonary embolism with acute corpulmonale, (23) ICD-10 Condition: A15||Respiratory tuberculosis, (24) ICD-10 Condition: J455||Severe persistent asthma, (25) ICD-10 Condition: S061||Traumatic cerebral edema, (26) ICD-10 Condition: S066||Traumatic subarachnoid hemorrhage, (27) ICD-10 Condition: S065||Traumatic subdural hemorrhage, (28) ICD-10 Condition: J22||Unspecified acute lower respiratory infection, (29) ICD-10 Condition: A879||Viral meningitis, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
 
Inclusion Criteria  
Age From  0.00 Year(s)
Age To  99.00 Year(s)
Gender  Both 
Details  All patients requiring ventilatory support or at high risk of needing it. 
 
ExclusionCriteria 
Details  All patients not requiring ventilatory support and identified not to be a respiratory emergency as per the study. 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Disease burden of respiratory emergencies reporting to the emergency department.
outcome and mortality of Respiratory emergencies. 
Data collection will go on for a period of 6 months from the date of CTRI approval.
Data collection will stop on or before 11.01.2021 if 6 months of data collection is complete. If it is not then a request for an IEC extension amendment will be requested.
All the outcome variables will be assessed after 6 months of data collection-anticipated January 2021.
 
 
Secondary Outcome  
Outcome  TimePoints 
ventilator usage during the COVID-19 pandemic at our center.  Daily census of ventilators will be recorded- in use, stand by, isolated for use, increase or decrease in availability this data will be studied on a monthly basis and cumulatively assessed at the end of the study period. 
 
Target Sample Size   Total Sample Size="700"
Sample Size from India="700" 
Final Enrollment numbers achieved (Total)= "766"
Final Enrollment numbers achieved (India)="766" 
Phase of Trial   N/A 
Date of First Enrollment (India)   01/06/2020 
Date of Study Completion (India) 31/12/2020 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="0"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  
Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details   Nil 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Brief Summary  

The COVID 19 pandemic has caused a shift in the normal paradigm and has instilled a fear in the world with its increasing mortality rate. While the signs and symptoms are predominantly respiratory in nature (fever, dyspnea, non-productive cough, sore throat); atypical presentations such as malaise, diarrhea and ST segment elevations have also been noted. Due to this fact that the symptomatology is largely non -specific and variable we may have COVID positive cases in treatment zones not allocated for them, but most importantly we will be able to assess the burden of respiratory emergencies due to any cause on a healthcare system which is allocating and redirecting resources to treat COVID-19 positive patients, which remains a challenging administrative decision. While outbreaks cannot be predicted for their timing, rates of increase or decrease and potential number at any given time, we will be able to assess the maximum availability and the use, on average, for patients who are not infected with COVID-19.

Epidemiology assesses risks that cannot be randomized and therefore such a study would be crucial in understanding the burden of such illnesses. It would help detect trends in conditions that would otherwise go under recognized, especially during the COVID – 19 pandemic. Furthermore, the fact this study would be conducted in the summer and monsoon period would serve as a model for further development of surveillance strategies and possible countermeasures.

 
Close