| CTRI Number |
CTRI/2025/09/095219 [Registered on: 22/09/2025] Trial Registered Prospectively |
| Last Modified On: |
19/09/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
To compare HFNC and standard oxygen therapy in terms of utilisation of health care resource and the amount of workload on the nursing staff |
|
Scientific Title of Study
|
High Flow Nasal Cannula Therapy versus Traditional oxygen therapy on Healthcare resource utilisation in Bronchiolitis |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Bhoomika Ganesh Hegde |
| Designation |
Post graduate |
| Affiliation |
Kmcri Hubli |
| Address |
Department of Paediatrics
Karnataka Medical College and Research Institute Vidyanagar Hubli
Dharwad
KARNATAKA
580021
India |
| Phone |
9113520412 |
| Fax |
|
| Email |
mgbhoomikahegde256@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Vinod H Ratageri |
| Designation |
Professor |
| Affiliation |
Kmcri Hubli |
| Address |
Department of Paediatrics ,Room no.104
Karnataka Medical College and Research Institute Vidyanagar Hubli
Dharwad
KARNATAKA
580021
India |
| Phone |
9448278480 |
| Fax |
|
| Email |
vhratageri@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Bhoomika Ganesh Hegde |
| Designation |
Post graduate |
| Affiliation |
Kmcri Hubli |
| Address |
Department of Paediatrics Karnataka Medical College and Research Institute Vidyanagar Hubli
Dharwad
KARNATAKA
580021
India |
| Phone |
9113520412 |
| Fax |
|
| Email |
mgbhoomikahegde256@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Bhoomika Ganesh Hegde |
| Address |
Karnataka medical college and research institute Hubli-580021,karnataka,India
Karntaka state
India |
| Type of Sponsor |
Other [Myself] |
|
|
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 BHOOMIKA G HEGDE |
KMCRI HUBLI |
Department of pediatrics ,103,Karnataka Medical college and Research Institute,hubli,dharwad ,580021,Karnataka ,India
VIDYANAGAR
HUBLI 580021
Dharwad
KARNATAKA |
9113520412
mgbhoomikahegde256@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| KMCRI |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: J219||Acute bronchiolitis, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
1.00 Month(s) |
| Age To |
2.00 Year(s) |
| Gender |
Both |
| Details |
Children 1 month to 2 years of age admitted to Paediatrics department with acute bronchiolitis
with Moderate to severe respiratory distress8 indicated by features such as SpO2 less than 92% on room
air, persistent increased work of breathing (nasal flaring, intercostal retractions), apnea episodes, or
need for frequent monitoring. |
|
| ExclusionCriteria |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
PICU Resource Utilization Score : We will compare mean and median NEMS scores between
groups as a quantitative outcome of resource use.
|
18 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Duration of Oxygen Therapy Total time the child remained on supplemental
oxygen of any kind. This ends when the child is weaned off O2 completely. A shorter oxygen
duration in one group might indicate faster recovery of respiratory status. |
18 months |
Adverse events or Complications.Any notable complications related to oxygen therapy.
For HFNC nasal mucosal injury, epistaxis, abdominal distension and vomiting (from high flow), aspiration .
For standard oxygen therapy nasal trauma from prongs, etc. |
|
Direct cost of treatment (exploratory) we will perform an approximate cost analysis using
hospital accounting data calculating oxygen consumption per patient (liters of Oxygen used, given
HFNC delivers high flow vs standard), consumables used (HFNC circuits vs simple cannulas), and
bed-day costs. While exact cost accounting for each patient is complex, we will estimate average
cost per patient in each group. A significant cost difference, if observed, will be reported |
|
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
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)
|
30/09/2025 |
| 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="1"
Months="6"
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
|
Acute respiratory distress is a leading cause of PICU admissions. Bronchiolitis is among the leading causes of hospitalization for infants and young children worldwide. In India, seasonal outbreaks lead to a surge of critically ill infants. Studies from tertiary centers in India report that over one-third of hospitalized bronchiolitis cases requiring Paediatric admission. These critically ill infants frequently need advanced respiratory support (e.g. non-invasive ventilation or intubation), contributing to prolonged hospital stays (median ~5–6 days) and notable mortality (~8%) in severe cases1. This substantial disease burden places significant strain on healthcare resources in resource-limited settings.Low- and middleincome countries (LMICs) like India face constraints in critical care infrastructure – PICU beds, ventilators, and trained personnel are limited relative to the paediatric population in need. Optimal allocation of these resources is crucial. |