| 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 |
|
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Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
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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 |
|
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Source of Monetary or Material Support
|
| Kasturba Medical College, Madhavnagar,Manipal,Karnataka-576104 |
|
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Primary Sponsor
|
| Name |
DrFreston Marc Sirur |
| Address |
Department of Emergency Medicine, Manipal, Karnataka-576104 |
| Type of Sponsor |
Other [self] |
|
|
Details of Secondary Sponsor
|
|
|
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 |
|
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Regulatory Clearance Status from DCGI
|
|
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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, |
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Intervention / Comparator Agent
|
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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. |
|
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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. |
|
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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)?
|
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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. |