| CTRI Number |
CTRI/2020/12/029563 [Registered on: 04/12/2020] Trial Registered Prospectively |
| Last Modified On: |
03/12/2020 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Follow Up Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
“AN OBSERVATIONAL STUDY OF HIGH FLOW NASAL OXYGEN THERAPY IN COVID 19 PATIENTS ADMITTED IN INTENSIVE CARE UNIT†|
|
Scientific Title of Study
|
An observational study of High Flow Nasal Oxygen Therapy in COVID-19 patients admitted in intensive care unit |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Ashwin sonkamble |
| Designation |
Associate professor |
| Affiliation |
Grant government medical college |
| Address |
Associate professor, Department of Anaesthesiology,
6th floor, main building, GGMC, JJ hospital campus.byculla
Associate professor, Department of Anaesthesiology,
6th floor, main building, GGMC, JJ hospital campus, byculla-08
Mumbai
MAHARASHTRA
400008
India |
| Phone |
|
| Fax |
|
| Email |
seeashwin@rediffmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Ashwin sonkamble |
| Designation |
Associate professor |
| Affiliation |
Grant government medical college |
| Address |
Associate professor, department of Anaesthesiology,
6th floor, main building, GGMC JJ hospital campus,byculla
Associate professor, Department of Anaesthesiology,
6th floor, main building, GGMC, JJ hospital campus, byculla-08
Mumbai
MAHARASHTRA
400008
India |
| Phone |
|
| Fax |
|
| Email |
seeashwin@rediffmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Ashwin sonkamble |
| Designation |
Associate professor |
| Affiliation |
Grant government medical college |
| Address |
Associate professor, department of Anaesthesiology, ggmc, JJ hospital campus.byculla
Associate professor, Department of Anaesthesiology,
6th floor, main building, GGMC, JJ hospital campus, byculla 08
Mumbai
MAHARASHTRA
400008
India |
| Phone |
|
| Fax |
|
| Email |
seeashwin@rediffmail.com |
|
|
Source of Monetary or Material Support
|
| Grant government medical college, JJ hospital, Byculla, Mumbai 400008 |
|
|
Primary Sponsor
|
| Name |
Not applicable |
| Address |
Not applicable |
| Type of Sponsor |
Other [Not applicable ] |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| not applicable |
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| DrAshwin sonkamble |
St George Hospital |
StGeorge Hospital,beside CST station, fort, Mumbai 400001
Mumbai
MAHARASHTRA |
9850961196
seeashwin@rediffmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethics committee, Grant government medical college |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) 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 |
60.00 Year(s) |
| Gender |
Both |
| Details |
1.Patients between age 18-60years
2.Both males and females
3.Patients with type 1 respiratory failure
4.Patients with SpO2 less than or equal to 92% on room air
5.Patients with or without co morbidities |
|
| ExclusionCriteria |
| Details |
1.Patient’s refusal for HFNO
2.Patients below 18years and above 60years
3. Patients with tracheostomy
4. Patients with Claustrophobia
5.Patients with urgent need for endotracheal intubation
6.Patients with GCS less than 8 or raised intracranial tension
7.Patients with upper airway obstruction
8. Pregnant patients |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Whether high flow nasal oxygen therapy can treat hypoxia in COVID 19 patients |
During ICU stay |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| 1.To analise failure rate of high flow nasal oxygen therapy in COVID 19 patients and escalation to invasive and non-invasive ventilation. |
during ICU stay |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
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)
|
10/12/2020 |
| 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="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
NIL
|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
This is an observational study of the utility of HFNO therapy in managing respiratory failure in moderate to severe COVID 19 patients who are admitted in intensive care unit and also to identify the early predictors of HFNO failure. |