| CTRI Number |
CTRI/2024/08/071774 [Registered on: 01/08/2024] Trial Registered Prospectively |
| Last Modified On: |
31/07/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Medical Device |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparative study of high flow nasal cannula and non invasive ventilation in patients with pneumonia. |
|
Scientific Title of Study
|
Effectiveness of high flow nasal cannula versus non invasive ventilation in management of moderate to severe cases of pneumonia - a randomised controlled trial. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Neha Rane |
| Designation |
Junior resident |
| Affiliation |
N. K. P. Salve Institute Of Medical Sciences & Research Centre Nagpur |
| Address |
Department of Respiratory Medicine, N. K. P. Salve Institute Of Medical Sciences & Research Centre And Lata Mangeshkar Hospital, Digdoh, Hingna Road, Nagpur 440016, Maharashtra, INDIA.
Department of Respiratory Medicine, N. K. P. Salve Institute Of Medical Sciences & Research Centre And Lata Mangeshkar Hospital, Digdoh, Hingna Road, Nagpur 440016, Maharashtra, INDIA.
Nagpur
MAHARASHTRA
440016
India |
| Phone |
7769058855 |
| Fax |
|
| Email |
drnrane@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Anil Sontakke |
| Designation |
Professor and Head of Department of Respiratory Medicine |
| Affiliation |
N. K. P. Salve Institute Of Medical Sciences & Research Centre Nagpur |
| Address |
Department of Respiratory Medicine, N. K. P. Salve Institute Of Medical Sciences & Research Centre And Lata Mangeshkar Hospital, Digdoh, Hingna Road, Nagpur 440016, Maharashtra, INDIA.
Department of Respiratory Medicine, N. K. P. Salve Institute Of Medical Sciences & Research Centre And Lata Mangeshkar Hospital, Digdoh, Hingna Road, Nagpur 440016, Maharashtra, INDIA.
Nagpur
MAHARASHTRA
440016
India |
| Phone |
9869027857 |
| Fax |
|
| Email |
anilsontakke66@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Anil Sontakke |
| Designation |
Professor and Head of Department of Respiratory Medicine |
| Affiliation |
N. K. P. Salve Institute Of Medical Sciences & Research Centre, Nagpur |
| Address |
Department of Respiratory Medicine, N. K. P. Salve Institute Of Medical Sciences & Research Centre And Lata Mangeshkar Hospital, Digdoh, Hingna Road, Nagpur 440016, Maharashtra, INDIA.
Department of Respiratory Medicine, N. K. P. Salve Institute Of Medical Sciences & Research Centre And Lata Mangeshkar Hospital, Digdoh, Hingna Road, Nagpur 440016, Maharashtra, INDIA.
Nagpur
MAHARASHTRA
440016
India |
| Phone |
9869027857 |
| Fax |
|
| Email |
anilsontakke66@gmail.com |
|
|
Source of Monetary or Material Support
|
| N.K.P Salve Institure of Medical Sciences and Research Centre and Lata Mangeshkar Hospital, Nagpur, Maharashtra, India, 440016 |
|
|
Primary Sponsor
|
| Name |
NKP Salve Institure of Medical Sciences and Research Centre and Lata Mangeshkar Hospital |
| Address |
CRPF nagar, Digdoh hills, Hingna road, Nagpur 440016, Maharashtra, India |
| Type of Sponsor |
Private medical college |
|
|
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 |
| Dr Neha Rane |
N.K.P Salve Institure of Medical Sciences and Research Centre and Lata Mangeshkar Hospital |
Department of Respiratory Medicine, N. K. P. Salve Institute Of Medical Sciences & Research Centre And Lata Mangeshkar Hospital, Digdoh, Hingna Road, Nagpur 440016, Maharashtra, INDIA.
Nagpur
MAHARASHTRA |
7769058855
drnrane@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| N.K.P Salve Institure of Medical Sciences and Research Centre and Lata Mangeshkar Hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: J960||Acute respiratory failure, (2) ICD-10 Condition: J189||Pneumonia, unspecified organism, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
High Flow Nasal Cannula |
Patients with moderate to severe pneumonia are randomised HFNC are applied for one group 72 hours. |
| Comparator Agent |
Non Invasive Ventilation |
Patients with moderate to severe pneumonia are randomised and NIV was applied to another group for 72 hours. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
85.00 Year(s) |
| Gender |
Both |
| Details |
Patients with moderate to severe pneumonia (CURB65 more than 2) requiring oxygenation (PaO2/FiO2 less than 300) (PaO2 less than 60).
Patints more than 18 years of age.
|
|
| ExclusionCriteria |
| Details |
Patients having contraindications of HFNC and NIV.
Patients requiring mechanical ventilation.
Patients not giving consent. |
|
|
Method of Generating Random Sequence
|
Random Number Table |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. Improvement in PaO2/FiO2
2. Improvement in PaO2
3.Improvement in Respiratory rate
4. Improvement in SpO2 |
1. Improvement in PaO2/FiO2 after 72 hours of HFNC/ NIV
2. Improvement in PaO2 after 72 hours of HFNC / NIV
3.Improvement in Respiratory rate after 72 hours of HFNC / NIV
4. Improvement in SpO2 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To study efficacy of NIV and HFNC in patients with moderate to severe pneumonia.
2. To study compliance of NIV and HFNC in patients. |
From application till 72 hours. |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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
|
Phase 2/ Phase 3 |
|
Date of First Enrollment (India)
|
12/08/2024 |
| 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="2"
Months="0"
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
|
Pneumonia with hypoxemic respiratory failure needs ICU admission along with oxygen therapy. There are various modalities of oxygen therapy such as conventional therapy with nasal cannula and face mask, high flow nasal cannula(HFNC) and noninvasive ventilation(NIV). High flow nasal cannula is less studied amongst all the modalities. Rationale of this study is to compare high flow nasal cannula with non invasive ventilation in patients of moderate to severe pneumonia requiring oxygen therapy. |