| CTRI Number |
CTRI/2025/05/087580 [Registered on: 26/05/2025] Trial Registered Prospectively |
| Last Modified On: |
23/05/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Predictors of High flow nasal cannula failure in children. |
|
Scientific Title of Study
|
Predictors of High Flow Nasal Cannula Failure in Children Admitted to Paediatric Intensive Care Unit |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Brinda M |
| Designation |
Postgraduate Student |
| Affiliation |
Manipal College of Health Profession |
| Address |
Department of Respiratory Therapy, Manipal Collage of Health Professions, MAHE, Manipal.
Udupi
KARNATAKA
576104
India |
| Phone |
9353423968 |
| Fax |
|
| Email |
brinda.mchpmpl2024@learner.manipal.edu |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sandeep Kumar B K |
| Designation |
Associate Professor |
| Affiliation |
Kasturba Hospital, Manipal |
| Address |
Department of Paediatrics, Kasturba Medical College, Manipal Academy of Higher Education, Manipal, India.
Udupi
KARNATAKA
576104
India |
| Phone |
8197120018 |
| Fax |
|
| Email |
kumar.sandeep@manipal.edu |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sandeep Kumar B K |
| Designation |
Associate Professor |
| Affiliation |
Kasturba Hospital, Manipal |
| Address |
Department of Paediatrics, Kasturba Medical College, Manipal Academy of Higher Education, Manipal, India.
Udupi
KARNATAKA
576104
India |
| Phone |
8197120018 |
| Fax |
|
| Email |
kumar.sandeep@manipal.edu |
|
|
Source of Monetary or Material Support
|
| Kasturba Hospital, Manipal-576104, Udupi, Karnataka, India |
|
|
Primary Sponsor
|
| Name |
Brinda M |
| Address |
Department of Respiratory Therapy, Manipal College of Health Profession, MAHE, Manipal-576104, Udupi, Karnataka, India |
| 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 |
| Dr Sandeep Kumar B K |
Kasturba Hospital |
Paediatric Intensive Care Unit, Kasturba Hospital, Manipal.
Udupi
KARNATAKA |
8197120018
kumar.sandeep@manipal.edu |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Kasturba Medical College and Kasturba Hospital Institutional Ethics Committee-2( Student Research) |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: J00-J99||Diseases of the respiratory system, |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
1.00 Month(s) |
| Age To |
18.00 Year(s) |
| Gender |
Both |
| Details |
Children aged 1 month to 18 years experienced Respiratory distress of any cause and have received HFNC Therapy |
|
| ExclusionCriteria |
| Details |
Children with Chronic lung Disease and Congenital Cyanotic Heart Disease and files with incomplete data |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| 1. To identify the predictors of HFNC failure |
1. 1hr, 4hr, 12hrs after initiation of HFNC. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
-To determine the threshold value of each parameter that is S/F ratio, p-ROX, PRESS score.
-To assess the outcomes of children on HFNC |
1. 1hr, 4hr, 12hrs after initiation of HFNC.
2. On escalation to non invasive ventilation or intubation. |
|
|
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
|
N/A |
|
Date of First Enrollment (India)
|
03/06/2025 |
| 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="0"
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
|
High Flow Nasal Cannula(HFNC) is a valuable respiratory support technique for adults, children, newborns, and infants. HFNC offers benefits over traditional oxygen therapy in the areas of humidification, oxygenation,CO2 clearance, and reduces respiratory distress. It is necessary to know the predictors of failure to guide the therapy. Data will be collected retrospectively from the medical records and will be analyzed to find the predictors of HFNC failure. Outcomes of HFNC and length of stay will be documented. The primary outcome is to identify the predictors of HFNC failure. The secondary outcomes are: To determine the threshold value of each parameter that is S/F ratio, p-ROX, PRESS score and to assess the outcomes of children on HFNC ( mortality). Hence, the results of this study will help in finding the parameters that will guide HFNC therapy. |