| CTRI Number |
CTRI/2025/02/080489 [Registered on: 13/02/2025] Trial Registered Prospectively |
| Last Modified On: |
30/01/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Oxygen Preparedness and Security Study |
|
Scientific Title of Study
|
Evaluating the Oxygen Preparedness & Security: A Mixed-Method Approach for Oxygen Survey |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Shakal Narayan Singh |
| Designation |
Professor |
| Affiliation |
King Georges Medical University |
| Address |
Department of Pediatrics, King Georges Medical University, Shahmina Road, Chowk
Lucknow UTTAR PRADESH 226003 India |
| Phone |
09935500661 |
| Fax |
|
| Email |
snsingh@kgmcindia.edu |
|
Details of Contact Person Scientific Query
|
| Name |
Shakal Narayan Singh |
| Designation |
Professor |
| Affiliation |
King Georges Medical University |
| Address |
Department of Pediatrics, King Georges Medical University, Shahmina Road, Chowk
UTTAR PRADESH 226003 India |
| Phone |
09935500661 |
| Fax |
|
| Email |
snsingh@kgmcindia.edu |
|
Details of Contact Person Public Query
|
| Name |
Shakal Narayan Singh |
| Designation |
Professor |
| Affiliation |
King Georges Medical University |
| Address |
Department of Pediatrics, King Georges Medical University, Shahmina Road, Chowk
UTTAR PRADESH 226003 India |
| Phone |
09935500661 |
| Fax |
|
| Email |
snsingh@kgmcindia.edu |
|
|
Source of Monetary or Material Support
|
| University of Edinburgh,
Old Medical School, Teviot Place, Edinburgh, EH8 9AG |
|
|
Primary Sponsor
|
| Name |
University of Edinburgh |
| Address |
University of Edinburgh
Old Medical School Teviot Place Edinburgh, EH8 9AG
United Kingdom |
| 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 Shakal Narayan Singh |
King Georges Medical University |
Department of Pediatrics, King Georges Medical University, Shahmina Road, Chowk Lucknow UTTAR PRADESH |
9415196707
snsingh@kgmcindia.edu |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| King Georges Medical University |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Public health facilities providing oxygen to the patients |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
NIL |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
For domain 1 Those who have extensive experience in designing, implementing, and evaluating healthcare related programs/policies.
For domain 2 Those who have at least 45 years of experience in an administrative position and actively participate in procurement and maintenance at the facility level.
For domain 3a Those who have been at their working station for at least six months.
For domain 3b Those who had direct exposure to the facility oxygen delivery systems or have been involved in oxygen related decisions, including adult patients and parents/caregivers of children.
For domain 4 Record of those patients who required oxygen.
For domain 5 This group includes patients who are currently admitted to the healthcare facility. |
|
| ExclusionCriteria |
| Details |
Individuals who are less than 18 years of age.
Individuals who are unwilling or unable to provide written informed consent
For domain 1 Individuals who lack the necessary experience or role within the healthcare system to provide valuable insights into policy formulation and implementation
For domain 2 Individuals who are not actively involved in facility administrative work or with less than 4 to 5 years of work experience in an administrative work.
For domain 3a Individuals who have been at their working station for less than six months.
For domain 3b Individuals who do not have direct exposure to the facility oxygen delivery systems or have not been involved in oxygen-related decisions.
For domain 4 Patients whose case notes or admission forms cannot be located in the ward.
For domain 5 Administrative staff who do not have adequate knowledge on facility finance. |
|
|
Method of Generating Random Sequence
|
Random Number Table |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Analyzing the existing policies and strategies related to medical oxygen. |
12 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| None |
None |
|
|
Target Sample Size
|
Total Sample Size="107" Sample Size from India="107"
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)
|
01/03/2025 |
| 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="0" Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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
|
Background:
a. Burden: Hypoxemia, characterized by low
blood oxygen levels, is a global health concern, further intensified by the
COVID-19 pandemic. This condition, which affects all age groups and accounts
for 14% of severe infections, can lead to increased mortality. Its causes range
from respiratory infections and cardiovascular disorders to neonatal
conditions. The 2017 Global Burden of Diseases Study highlights the widespread
nature of chronic respiratory diseases, which affect 545 million people
worldwide and are the third leading cause of death across all age groups.
However, these diseases disproportionately impact South Asia, especially in
low- and middle-income countries (LMICs), where children are at a higher risk.
In these regions, 10-15% of hospitalized children and 20% of sick newborns
suffer from hypoxemia, primarily due to limited oxygen access.
b. Knowledge
gap: Despite the recognized global
impact of hypoxemia, a knowledge gap impedes a comprehensive understanding.
Current research often concentrates on specific diseases or patient groups,
thereby restricting a broader perspective necessary for effective interventions.
The appropriateness of the World Health Organization’s (WHO) SpO2
threshold of 90% as a hospital admission criterion is under scrutiny,
especially in regions like Malawi, where children under five may face mortality
risks even with SpO2 levels above 90%. Moreover, there is a
significant lack of attention towards the accessibility and security of oxygen
supply in LMICs.
c. Relevance: This study is particularly relevant
in the context of the ongoing COVID-19 pandemic. By assessing the readiness of
oxygen delivery systems in LMICs such as India, the research addresses vital
gaps in healthcare infrastructure. The insights gained from this evaluation can
benefit healthcare providers, policymakers, and the general population. The
timing of the study coincides with the pressing need for efficient healthcare
delivery during public health emergencies. The results can guide strategies to
improve oxygen security and accessibility, which are essential for reducing the
impact of hypoxemia and enhancing healthcare outcomes in resource-constrained
settings.
Hypothesis (if
any):
N/A
Objectives:
The objective of
the proposed study is to assess the readiness of oxygen security and
availability, with a particular emphasis on improving healthcare delivery for
respiratory symptoms in primary, secondary and tertiary level healthcare
facilities in 10 districts of Uttar Pradesh. The study will investigate various
aspects, including accessibility, equipment functionality, infrastructure,
training needs, adherence to protocols, and financial feasibility.
Methods:
This study adopts
a mixed-methods approach to evaluate the preparedness of oxygen delivery
systems in Uttar Pradesh, India. It uses a cross-sectional health facility
assessment survey, a healthcare provider survey, and key informant interviews.
The study is structured into five domains. The domain 1 investigates
governance, policies, and strategies. The domain 2 examines oxygen access
through a representative sample of health facilities. The domain 3 assesses
healthcare provider knowledge and patient/caregiver perception. The domain 4
scrutinizes documented oxygen uses and demand. The domain 5 explores the cost
implications of oxygen delivery.
The aim of the
study is to provide a comprehensive understanding of the current state of
oxygen delivery systems in Uttar Pradesh. It seeks to inform strategies for
improvement and enhance healthcare outcomes. The study’s comprehensive approach
ensures a thorough examination of all aspects of oxygen delivery systems,
laying a solid foundation for future research and intervention strategies. The
findings of the study will be crucial in informing policy decisions and
interventions aimed at improving healthcare outcomes in Uttar Pradesh, India.
Outcome
measures/variables:
The study aims to
assess oxygen delivery system readiness in Uttar Pradesh, India across five
domains. Domain 1 focuses on analyzing existing policies and strategies. Domain
2 evaluates the impact of oxygen delivery system components’ availability on
overall therapy capacity. In Domain 3a, the outcome variable measures
healthcare providers’ knowledge, attitude, and skills in using oxygen therapy.
Domain 3b assesses patient, parent, and caregiver perceptions and their
influence on treatment acceptance. Domain 4 examines documented oxygen use and
demand in healthcare facilities. Domain 5 estimates the cost of implementing
and maintaining oxygen systems, considering both facility and patient financial
perspectives. These outcome variables collectively offer insights into system
readiness and guide strategies for improving oxygen security and availability. |