| CTRI Number |
CTRI/2025/01/078889 [Registered on: 17/01/2025] Trial Registered Prospectively |
| Last Modified On: |
17/01/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Follow Up Study |
| Study Design |
Other |
|
Public Title of Study
|
A holistic approach to reduce oxygen wastage in tertiary care hospital |
|
Scientific Title of Study
|
A comprehensive approach for prevention of oxygen wastage in tertiary care center |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Rupika E |
| Designation |
Research Scholar |
| Affiliation |
Mahatma Gandhi Medical College and Research Institute, Sri Balaji Vidyapeeth |
| Address |
B Block, 2nd Floor, Department of Anesthesiology, Mahatma Gandhi Medical College and Research Institute, Pondicherry-Cuddalore Road, ECR Pillaiyarkuppam Puducherry
Pondicherry
PONDICHERRY
607402
India |
| Phone |
8610716968 |
| Fax |
|
| Email |
erupika13@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Rupika E |
| Designation |
Research Scholar |
| Affiliation |
Mahatma Gandhi Medical College and Research Institute, Sri Balaji Vidyapeeth |
| Address |
B Block, 2nd Floor, Department of Anesthesiology, Mahatma Gandhi Medical College and Research Institute, Pondicherry-Cuddalore Road, ECR Pillaiyarkuppam Puducherry
Pondicherry
PONDICHERRY
607402
India |
| Phone |
8610716968 |
| Fax |
|
| Email |
erupika13@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Rupika E |
| Designation |
Research Scholar |
| Affiliation |
Mahatma Gandhi Medical College and Research Institute, Sri Balaji Vidyapeeth |
| Address |
B Block, 2nd Floor, Department of Anesthesiology, Mahatma Gandhi Medical College and Research Institute, Pondicherry-Cuddalore Road, ECR Pillaiyarkuppam Puducherry
Pondicherry
PONDICHERRY
607402
India |
| Phone |
8610716968 |
| Fax |
|
| Email |
erupika13@gmail.com |
|
|
Source of Monetary or Material Support
|
| Mahatma Gandhi Medical College and Research Institute, Pondicherry-Cuddalore Road, ECR Pillaiyarkuppam, Puducherry, India - 607402 |
|
|
Primary Sponsor
|
| Name |
Mahatma Gandhi Medical College and Research Institute |
| Address |
Mahatma Gandhi Medical College and Research Institute, Pondicherry-Cuddalore Road, ECR Pillaiyarkuppam, Puducherry, India - 607402 |
| Type of Sponsor |
Research institution and hospital |
|
|
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 P Rani |
Mahatma Gandhi Medical College and Research Institute |
B Block, 2nd Floor, Department of Anaesthesiology, Mahtma Gandhi Medical College and Research Institute, Pondicherry- Cuddalore Road, ECR Pillaiyarkuppam, Pondicherry 607402
Pondicherry
PONDICHERRY |
9365815939
anaesrani@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL HUMAN ETHICS COMMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Human volunteers who were healthy with good oxygen saturation |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
NIL |
NIL |
| Intervention |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
75.00 Year(s) |
| Gender |
Both |
| Details |
Healthy volunteers |
|
| ExclusionCriteria |
| Details |
Critically ill patients
Hypoxia patients
Individuals with unstable hemodynamic parameters
Age below 18 years and above 75 years |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Sensor based facemask helps in reducing oxygen wastage |
Last phase of the study 14th month |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Awareness among staff nurses regarding oxygen wastage and conservation will decrease the oxygen wastage |
After 6 months of phase 1 audit |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
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 3 |
|
Date of First Enrollment (India)
|
29/01/2025 |
| 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
|
The study is to reduce oxygen wastage in hospitals, which is necessary for human life (an essential medicine). This study will be conducted in 3 phases: phase 1 will be conducting an oxygen audit for a period of 6 months; phase 2 will be conducting an awareness program for staff nurses in our hospital; phase 3 will be designing a device and validation; the device will be trialed in healthy volunteers to get validation. |