| CTRI Number |
CTRI/2021/02/031138 [Registered on: 09/02/2021] Trial Registered Prospectively |
| Last Modified On: |
09/02/2021 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Observational descriptive Record Based Study |
| Study Design |
Other |
|
Public Title of Study
|
Observational study of severity and outcomes of artificially respiring COVID-19 positive patients with COVID-19 Complication causing respiratory distress. |
|
Scientific Title of Study
|
Severity and Outcomes of Mechanically Ventilated COVID-19 patients - A Retrospective Study |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Monica Patricia Lobo |
| Designation |
Student |
| Affiliation |
Father Muller Medical College |
| Address |
3rd Year MBBS, Father Muller Medical College, Father Muller Road, Kankanady, Mangalore-575002
Dakshina Kannada
KARNATAKA
575002
India |
| Phone |
9535692304 |
| Fax |
|
| Email |
mlobo4669@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Glenn Austin Fernandez |
| Designation |
Assistant Professor of General Medicine |
| Affiliation |
Father Muller Medical College |
| Address |
Assistant Professor, Department of General Medicine, Father Muller Medical College, Father Muller Road, Kankanady, Mangalore-575002
Dakshina Kannada
KARNATAKA
575002
India |
| Phone |
8884875845 |
| Fax |
|
| Email |
glennindia@fathermuller.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Glenn Austin Fernandez |
| Designation |
Assistant Professor of General Medicine |
| Affiliation |
Father Muller Medical College |
| Address |
Assistant Professor, Department of General Medicine, Father Muller Medical College, Father Muller Road, Kankanady, Mangalore-575002
Dakshina Kannada
KARNATAKA
575002
India |
| Phone |
8884875845 |
| Fax |
|
| Email |
glennindia@fathermuller.in |
|
|
Source of Monetary or Material Support
|
| Father Muller Medical College Hospital, Father Muller Road, Kankanady, Mangalore-575002 |
|
|
Primary Sponsor
|
| Name |
Monica Patricia Lobo |
| Address |
Father Muller Medical College, Father Muller Road, Kankanady, Manglore-575002 |
| 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 |
| Monica Patricia Lobo |
Father Muller Medical College Hospital |
COVID-19 ICU, Department of General Medicine, Father Muller Medical College Hospital, Father Muller Road, Kankanady, Mangalore-575002
Dakshina Kannada
KARNATAKA |
9535692304
mlobo4669@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Father Muller Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: A00-B99||Certain infectious and parasitic diseases, (2) ICD-10 Condition: B972||Coronavirus as the cause of diseases classified elsewhere, |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
Patients tested positive for COVID-19 by RT-PCR
Patients requiring mechanical ventilation in the COVID-19 ICU of a tertiary care medical college hospital for Acute Respiratory Distress Syndrome |
|
| ExclusionCriteria |
| Details |
Patients tested Positive for COVID-19 by RT-PCR, requiring mechanical ventilation in the COVID-19 ICU of a tertiary care medical college hospital for reasons other than Acute Respiratory Distress Syndrome.
Patients whose age is less than 18 years.
Pregnant patients who are tested positive.
|
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Severity and outcomes of mechanically ventilated patients will be measured by various parameters on a pre-designed proforma and assessed. |
It is a retrospective observational study, Hence there are no time points. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Not applicable |
It is a retrospective study |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
15/02/2021 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="0"
Months="5"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
It is a Observational Descriptive Record Based study on the association of severity and outcomes of mechanically ventilated COVID-19 patients with Acute Respiratory Distress Syndrome. This is a retrospective study on the COVID-19 positive patients during the pandemic in a tertiary care teaching college hospital. It assess the severity and outcomes of mechanically ventilated COVID-19 patients with ARDS respectively on a pre-designed proforma and correlates the both. |