| CTRI Number |
CTRI/2024/02/062209 [Registered on: 01/02/2024] Trial Registered Prospectively |
| Last Modified On: |
09/08/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Medical Device |
| Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
|
Public Title of Study
|
Clinical Efficacy of the Indigenously Developed Oxygen delivery device : A Pilot Study |
|
Scientific Title of Study
|
Clinical Efficacy of the Indigenously Developed High Flow Nasal Cannula Device (TrueOxy+ HFNC Device): A Pilot Study |
| 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 Shiv Lal Soni |
| Designation |
Associate Professor |
| Affiliation |
Postgraduate Institute of Medical Education and Research (PGIMER), Chandigarh |
| Address |
Department of Anaesthesia and Intensive Care, Postgraduate Institute of Medical Education and Research (PGIMER), Chandigarh
Chandigarh
CHANDIGARH
160012
India |
| Phone |
9914208550 |
| Fax |
|
| Email |
dr.shivsoni@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Shiv Lal Soni |
| Designation |
Associate Professor |
| Affiliation |
Postgraduate Institute of Medical Education and Research (PGIMER), Chandigarh |
| Address |
Department of Anaesthesia and Intensive Care, Postgraduate Institute of Medical Education and Research (PGIMER), Chandigarh
Chandigarh
CHANDIGARH
160012
India |
| Phone |
9914208550 |
| Fax |
|
| Email |
dr.shivsoni@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Shiv Lal Soni |
| Designation |
Associate Professor |
| Affiliation |
Postgraduate Institute of Medical Education and Research (PGIMER), Chandigarh |
| Address |
Department of Anaesthesia and Intensive Care, Postgraduate Institute of Medical Education and Research (PGIMER), Chandigarh
Chandigarh
CHANDIGARH
160012
India |
| Phone |
9914208550 |
| Fax |
|
| Email |
dr.shivsoni@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Science and Technology (DST) |
|
|
Primary Sponsor
|
| Name |
Department of Science and Technology (DST) |
| Address |
Department of Science and Technology (DST), Technology Bhavan, New Mehrauli Road, Block C, Qutab Institutional Area, New Delhi, Delhi-110016 |
| Type of Sponsor |
Government funding agency |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Postgraduate Institute of Medical Education and Research |
Postgraduate Institute of Medical Education and Research, Sector 12, Chandigarh, India |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Shiv Lal Soni |
Postgraduate Institute of Medical Education and Research |
Clinical Pharmacology Unit (CPU), Level 2, Block-C, Nehru Hospital, PGIMER, Sector 12, Chandigarh-160012
Chandigarh
CHANDIGARH |
9914208550
dr.shivsoni@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee PGIMER Chandigarh |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
1.Healthy men and women aged between 20-50 years, 2.Have normal hemogram and renal function test in the past 6 months, 3.BMI 18 to 30, 4.Non-smokers and no history of respiratory disease
|
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
HFNC 20 lpm group |
HFNC will be applied to the participant at a constant flow of 20 LPM and serial blood gasses will be sampled from a pre-inserted radial catheter at 20 minutes after each change in FiO2 starting from 0.4 to 1 in steps of 0.2 |
| Intervention |
HFNC 40 lpm group |
HFNC will be applied to the participant at a constant flow of 40 LPM and serial blood gasses will be sampled from a pre-inserted radial catheter at 20 minutes after each change in FiO2 starting from 0.4 to 1 in steps of 0.2 |
| Intervention |
HFNC 60 lpm group |
HFNC will be applied to the participant at a constant flow of 60 LPM and serial blood gasses will be sampled from a pre-inserted radial catheter at 20 minutes after each change in FiO2 starting from 0.4 to 1 in steps of 0.2 |
| Comparator Agent |
Not applicable |
Not applicable |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
1. Healthy men and women aged between 20-50 years
2. Willing to give written, informed consent
3. Willing to comply with protocol requirements
4. Normal physical & systemic examination
5. Have normal hemogram and renal function test in the past 6 months
6. BMI 18 to 30
7. Non-smokers and no history of respiratory disease |
|
| ExclusionCriteria |
| Details |
1.Elderly, above 50 years
2.Known respiratory disease
3.Recent less than 3 months mechanical ventilation ICU, hospital admission
4.Anemia
5.History of Hemoglobinopathy, sickle cell disease, thalassemia
6 Positive pregnancy test, females
7.Significant cardiac or pulmonary disease
8.History of sleep apnea
9.Tobacco, drug or alcohol abuse
10.Difficult airway
11.Abnormal ekg, pulmonary function test, room air saturation
12.Intolerance to HFNC apparatus
13.Participation in Phase I study in previous 6 months or in Phase 2 or 3 studies in previous 3 months
|
|
|
Method of Generating Random Sequence
|
Random Number Table |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| 1. Agreement between measured and predicted arterial partial pressure of oxygen PaO2 for each FiO2 percentage change |
At Baseline and after 20 minutes for all 4 sessions intervention sessions mentioned in study protocol |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Change in vital parameters (HR, BP, SpO2, RR) at the end of each session from baseline
|
every 5 minutes from start of intervention till 1 hour after the end of intervention. |
| Proportion of patients experiencing adverse and serious adverse events. |
every 5 minutes from start of intervention till 1 hour after the end of intervention. |
|
|
Target Sample Size
|
Total Sample Size="21"
Sample Size from India="21"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="0" |
|
Phase of Trial
|
Phase 1 |
|
Date of First Enrollment (India)
|
05/02/2024 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="3"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - YES
- What data in particular will be shared?
Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).
- What additional supporting information will be shared?
Response - Study Protocol
Response - Statistical Analysis Plan
Response - Informed Consent Form
- Who will be able to view these files?
Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.
- For what types of analyses will this data be available?
Response - For individual participant data meta-analysis.
- By what mechanism will data be made available?
Response - Proposals should be directed to [dr.shivsoni@gmail.com].
- For how long will this data be available start date provided 05-02-2024 and end date provided 04-02-2027?
Response - Beginning 9 months and ending 36 months following article publication.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
This study aims to investigate clinical efficacy of the Indigenously Developed High Flow Nasal Cannula Device (TrueOxy+ HFNC Device) on the healthy individuals. The prime clinical benefit of this HFNC is its efficiency in delivering supplemental oxygen with humidification and at higher flows which satisfy the patients’ peak inspiratory flow rate. The performance of this device in this trial will enable the production of an indigenously developed low-cost HFNC device which will be potentially cost saving to several hospitals while providing clinical benefit to the patients. This study aims to clinically test this device on healthy volunteers to demonstrate its efficacy in increasing the oxygenation at various flow rates. |