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CTRI Number  CTRI/2024/02/062233 [Registered on: 02/02/2024] Trial Registered Prospectively
Last Modified On: 02/02/2024
Post Graduate Thesis  No 
Type of Trial  Observational 
Type of Study   Community survey 
Study Design  Other 
Public Title of Study   A study to see the effect of the Pulse Oximeter (an electronic device that measures the saturation of oxygen carried in the blood) on behaviour of the provider and on patient management practices 
Scientific Title of Study   Impact of the Pulse Oximeter on providers’ behaviour and patient management practices across resource limited settings (Outcome Study) 
Trial Acronym  Outcome 
Secondary IDs if Any  
Secondary ID  Identifier 
901016_Protocol Version 2.0 dated 06.01.24  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Reshma Ambulkar 
Designation  Professor and Head 
Affiliation  Tata Memorial Centre 
Address  Department of Anesthesia Critical care and Pain, Advanced Centre for Treatment, Research and Education in Cancer, Kharghar, Navi Mumbai

Mumbai (Suburban)
MAHARASHTRA
410210
India 
Phone  9821790448  
Fax    
Email  rambulkar@hotmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Reshma Ambulkar 
Designation  Professor and Head 
Affiliation  Tata Memorial Centre 
Address  Department of Anesthesia Critical care and Pain, Advanced Centre for Treatment, Research and Education in Cancer, Kharghar, Navi Mumbai


MAHARASHTRA
410210
India 
Phone  9821790448  
Fax    
Email  rambulkar@hotmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Reshma Ambulkar 
Designation  Professor and Head 
Affiliation  Tata Memorial Centre 
Address  Department of Anesthesia Critical care and Pain, Advanced Centre for Treatment, Research and Education in Cancer, Kharghar, Navi Mumbai


MAHARASHTRA
410210
India 
Phone  9821790448  
Fax    
Email  rambulkar@hotmail.com  
 
Source of Monetary or Material Support  
Lifebox foundation, 48 Charlotte Street, London, W1T 2NS. 
 
Primary Sponsor  
Name  Lifebox foundation 
Address  Lifebox foundation, 48 Charlotte Street, London, W1T 2NS. 
Type of Sponsor  Other [Non Profit Organisation] 
 
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 Reshma Ambulkar  Advanced Centre for Treatment, Research and Education (ACTREC)  Department of Anaesthesia, Critical Care and Pain, 7th Floor, RRS Building, ACTREC, Kharghar
Mumbai (Suburban)
MAHARASHTRA 		 9821790448

rambulkar@hotmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Tata Memorial Centre_Institutional Ethics Committee III  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Healthcare providers using the pulse oximeter in their clinical practice daily 
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Nil  NA 
Comparator Agent  Nil  NA 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  80.00 Year(s)
Gender  Both 
Details  1. Healthcare providers employed by the designated study sites and reference institute using the pulse oximeter in their clinical practice daily. 
 
ExclusionCriteria 
Details  1. Healthcare providers who refuse to consent for participation in the study.
2. Healthcare personnel not involved in patient care.
3. Health care workers not using pulseoximeters.
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
1. To compare the knowledge and attitudes of health workers from the selected facilities to those working in a tertiary care hospital adhering to the WHO-WFSA guidelines (2)  At 3 months 
 
Secondary Outcome  
Outcome  TimePoints 
1. To determine the effect of the pulse oximeter and the associated pulse oximetry training offered on the knowledge and attitudes of the health workers from the selected facilities compared to baseline.
2. To determine the number of pulse oximeters per selected facility and their distribution within the facility to determine if a gap exists.
 		 At 3 months 
 
Target Sample Size   Total Sample Size="500"
Sample Size from India="500" 
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)   15/02/2024 
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 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  

Executive summary

World over, pulse oximetry has revolutionized safety of anesthesia and surgery. The Lifebox foundation has been at the helm of distributing pulse oximeters across resource limited settings in a bid to ensure that a basic minimum is achieved where patient monitoring in the perioperative period is concerned. Despite these strides, there is little known about the overall impact of the use of the pulse oximeter on the health care provider’s behaviour in the workspace and on the decision-making process. This study will run over a period of twelve months. We will collect baseline data related to pulse oximetry in the selected units as well as have key informant interviews to further evaluate the impact of pulse oximetry on the quality of care. The data collected will be used to inform Lifebox’s strategic plan and the lessons learnt will be published in a peer reviewed journal.

Background

Pulse oximetry is at the heart of the Lifebox (1) foundation’s work to improve the safety of anaesthesia. Lifebox aims to ensure that essential monitoring of oxygen levels happens with every surgery that takes place. A pulse oximeter is a simple, highly effective non-invasive monitoring device that has revolutionised the safety of anesthesia and surgery. It is considered a critical device and its use is a minimum standard for safe anaesthesia according to the World Health organization- World Federation of Societies of Anaethesiologists (WHO-WSFA) (2). It is the only piece of equipment included on the WHO Surgical Safety Checklist and yet thousands of operating rooms around the world still lack this essential monitoring device.

The Lifebox pulse oximetry program launched with the founding aim to close the “oximetry gap” by equipping operating rooms with this essential safety device following a landmark paper that estimated 77,000 operating rooms in the world had no pulse oximetry (3). The Lifebox pulse oximeter was specifically designed with the low-resource settings in mind – with robust construction and rechargeable batteries that stay on even when the power fails. To date, more than 34,000 Lifebox pulse oximeters have been distributed throughout 116 countries for vital patient monitoring, with more than 33 million lives safeguarded. The distribution is accompanied by oximetry and anaesthesia safety training, recognizing that for many of the recipients this is their first patient monitoring technology.

Despite these successes, there is little evidence on how a pulse oximeter introduced into a hospital system impacts provider behaviour and critical patient care (4). In addition, need to understand how providers use and respond to hypoxaemic episodes, how information gained from pulse oximetry is communicated between providers, how these devices influence decisions and practices, or what additional needs and challenges arise following distribution to facilities. 

 The main purpose of this study is to understand and evaluate the impact of the pulse oximeter on providers’ behaviour and knowledge about pulseoximeter as well address the gap which yet exists in LMIC lacking the mandatory monitor.

Significance of the study

This study will inform the next steps in Lifebox foundation’s strategic plan: training and potentially guide distribution patterns and provide insight into the modifiable behaviours that may have a significant impact on patient healthcare and safety.

Objectives

Aim:

To evaluate the accessibility and impact of the use of pulse oximeter and pulse oximetry training on health care providers’ knowledge and attitudes within health facilities in selected resource-limited settings where previously oximeters were not readily available and compare them to those in a high-volume tertiary care hospital.

Specific objectives:

  1. To compare the knowledge and attitudes of health workers from the selected facilities to those working in a tertiary care hospital adhering to the WHO-WFSA guidelines (2)
  2. To determine the effect of the pulse oximeter and the associated pulse oximetry training offered on the knowledge and attitudes of the health workers from the selected facilities compared to baseline.
  3. To determine the number of pulse oximeters per selected facility and their distribution within the facility to determine if a gap exists.

Methodology

Study Design and procedure:

1.       A prospective cohort mixed methods research design will be used to carry out this study.

2.      We will train research assistants to collect data.

3.      We shall use a pretested questionnaire to collect baseline quantitative data from the facilities (“Test centres”) and have focus group discussions and/or key informant interviews (where the selected health worker number is too small for a focus group discussion).

4. The control, or standard arm will comprise of health workers in a tertiary care “reference institute” who will be administered the same questionnaire as the study arm at baseline. 

5.      Study arm will comprise of health workers who will be provided with pulse-oximeters and training regarding their use after collecting the baseline data.

6.     We will then return to the facilities 3 months post the distribution of pulse-oximeter (if needed) and training (if needed by the test centres) and collect follow up data from these facilities.

7.   The baseline and follow-up data from the study arm will be compared to the baseline data from the control arm to assess the magnitude of gaps in training at baseline as well as at 3 months follow up.

Study sites

The following centres from the north-east region of India have been selected as the “Test centres”.

1.     Naga Hospital Authority, Kohima, Nagaland, India.

2.     J.N. Institute of Medical Sciences, Porompat, Manipur, India.

3.     Tomo Riba Institute Of Health And Medical Sciences (TRIHMS), Naharlagun

4.     Kokrajhar Medical College and Hospital, Kokrajhar, Assam, India.

5.     Sohra Community health centre, Sohra, Cherrapunjee, Meghalaya, India.

6.     Tripura Cancer Hospital, Agartala, Tripura, India.

The Tata Memorial Centre, ACTREC, Navi Mumbai will be designated as the “reference centre” for recruiting participants in the control arm. Health workers as described below working in theatres, post anesthesia care units (PACU), Intensive care units (ICU), the emergency departments and the ward will be selected to participate in the study.

The study will later be expanded to include centres from additional countries as well.

Study population

All healthcare providers who work in departments where pulse oximeters are used will be targeted for inclusion into the study. These departments include the operating room, emergency department, post anesthesia care unit, Intensive care units and the hospital wards. Anaesthesia providers, both physicians and non-physicians, nurses, other physicians and health workers involved in the emergency medical services including emergency medicine physicians will participate from the study sites as above.

Study procedures

Pulse-oximeters will be distributed to the test centres based on their individual needs. Training on using the pulse-oximeters as well as interpretation of results will be provided via a structured workshop conducted by the study investigator at each centre following the distribution of the pulse-oximeters.

 
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