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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  
Name  Address 
NIL  NIL 
 
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  
Status 
Not Applicable 
 
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.

 
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