Bacterial colonization on frequently touched objects of critical care units in

tertiary care hospital of Western Nepal

RESEARCH PROPOSAL
Submitted to

Institutional Review Committee (IRC)

Manipal College of Medical Sciences

Fulbari, Pokhara.

Phone no. 061-526416 extn 399

Email: irc.mcoms@manipal.edu.np

For approval of research proposal and ethical clearance

Principal Investigator:
Name: Sumnima Koirala
Designation: B Sc (Medical Microbiology) final year student
Department: Medical Microbiology
Institute: Nobel College
Address: Sinamangal, Kathmandu
Phone number: 9846723685
Email: koiralasumnima1999@gmail.com
Detailed information of investigators
Principal Investigator

S. N. Full name Details Contribution Signature

1. Sumnima Designation: Student Proposal writing,

Koirala Full qualification: B Sc (Medical Sample collection,
Microbiology) final year student Processing, data
Department: Medical Microbiology collection and
Institute: Nobel College, Sinamangal, storage
Kathmandu
Mobile number: 9846723685
Email: koiralasumnima1999@gmail.com

Co-investigators

S. Full name Details Contribution Signature

N.

1. Abha Baral Designation: Student Proposal writing,

Full qualification: B Sc (Medical Sample
Microbiology) final year student collection,
Department: Medical Microbiology Processing, data
Institute: Nobel College, Sinamangal, collection and
Kathmandu storage
Mobile number: 9862279393
Email: baralaabha@gmail.com
2. Dr Dharm Designation: Associate Professor Proposal editing,
Raj Bhatta Full qualification: formulating
M Sc, PhD objectives,
Department: Microbiology manuscript
Institute: MCOMS preparation and
Mobile no. : 9806669798 editing.
Email: ddharma2039@gmail.com
1. Bacterial colonization on frequently touched objects of critical care units in
tertiary care hospital of Western Nepal

2. Introduction

Intensive Care Unit (ICU) is important part of effective healthcare setting for life threatening
cases. Intensive Care Unit provides interdisciplinary care for severely ill patients in
technologically advanced environment to ensure normal body function. Patients admitted in ICU
are usually immunocompromised due to various underlying conditions and are vulnerable to
nosocomial infections. Bacterial contamination of objects/instruments in ICUs is one of the
major sources of nosocomial infections. The outbreaks of nosocomial infections in ICUs due to
bacterial flora from patients, hands of HCWs and environment have been reported. Important
contributory factors include poor hand hygiene, overcrowding, understaffing and inadequately
trained staff. Approximately one-third of all nosocomial infections would be preventable if
hospitals had effective infection control protocols [3]. Various bacterial pathogens have been
implicated in ICUs contamination, but clinically important pathogens include Staphylococcus
aureus including methicillin resistant Staphylococcus aureus (MRSA), coagulase negative
Staphylococci, Klebsiella species, Escherichia coli, Pseudomonas species, Acinetobacter
species and Enterococcus species. Increasing drug resistance among pathogens and emergence of
multidrug resistant (MDR) organisms like MRSA, VRSA, ESBL producing Enterobacteriaceae
and Acinetobacter species causing infection among ICU patients result in high morbidity and
mortality.

This study is aimed to determine the level of bacterial contamination in critical care unit
environment, particularly on instruments/objects which frequently come in contact with patients
and are commonly touched by HCWs.
3. Aims and objectives of the study

 To isolate and identify bacterial agents from objects/instruments of critical care units.
 To determine the antimicrobial susceptibility pattern of bacterial isolates.
 To detect MRSA and ESBL producing organisms.
 To access the MIC of Vancomycin by Epsilometer (E) test.

4. Materials and Methods

4.1 Research method: Quantitative

4.2 Type of study: Hospital based prospective study

4.3 Study population: Frequently touched inanimate objects/instruments of critical care units

4.4 Study site: Manipal Teaching hospital, Pokhara, Nepal.

4.5: Sampling method: Non probability sampling

4.6: Sample size: With reference to Bhatta et al., [10]

Expected Prevalence P= 0.746

The formula for calculating sample size is:
( )

Where; N= sample size

Z= level of confidence (1.96)

P= expected prevalence
d= precision (0.05)
Thus, a total of 291 samples will be taken.
4.7 Inclusion and Exclusion criteria

Inclusion criteria

Objects/instruments which are frequently touched by hands of healthcare workers and/or patients
will be included

Exclusion criteria

Objects/instruments which are regularly cleaned/ disinfected will be excluded.

4.8 Study variables

Dependent variables

Contamination rate, frequency of disinfection/fumigation procedure, occupancy (patients load),

type of illness

Independent variables

Objects, Instruments

4.9 Expected time and duration of the study

The study will be conducted after approval from Institutional Review Committee. Duration of
study will be three months.

4.10 Tools and Techniques for data collection

Specimen collection and identification of organism:

Samples will be collected from various surfaces like door handles, nursing station,
sphygmomanometer, stethoscope, defibrillators, syringe stand, medicine trolley, dressing drum,
bed railings, , ventilators, door handles, telephone sets, wall BPL monitors, washing tap and
stretcher. Samples will be collected by rubbing sterile swabs pre moistened with sterile peptone
water on each of the surfaces. Identification of the isolates was performed by standard
microbiological techniques such as colony morphology, microbiological examination, and
standard phenotypic characters.

Antibiotic susceptibility testing of the isolates will be performed on Mueller Hinton Agar (HI
media, Mumbai, India) by Kirby Bauer disc diffusion method [5]. Bacterial isolates showing
resistance to at least one agent in three or more antimicrobial categories will be labeled as
multidrug resistant (MDR) bacteria.

Methicillin resistant Staphylococcus aureus (MRSA) will be screened by cefoxitin (30µg) disc
diffusion method. Extended Spectrum Beta Lactamase (ESBL) production among Gram negative
bacilli will be performed by standard disc diffusion methods.

4.11Plan for Data Collection

Data obtained from bacteriological culture of the samples collected from different sites of critical
care units and antibiotic susceptibility test will be recorded.

4.12 Plan for Data Management and analysis

Collected data will be entered in excel sheet. The data will be analyzed using SPSS version 16.

5. Limitation of the study

Anaerobic bacterial isolates will not be included in this study due to unavailability of the facility.

Molecular testing of the bacterial isolates will not be performed.

6. Safety considerations

Not applicable

7. Ethical issues and considerations

Permission to conduct research study will be taken from IRC, MCOMS, Pokhara, Nepal.

Informed verbal consent will be obtained from the participants.

Confidentiality of the data will be maintained and used only for research purpose.
References

1. Moreno, R., B. Singer, and A. Rhodes, What is an ICU. Organization and management of
intensive care. Flaatten H, Moreno RP, Putensen C, Rhodes A (eds.). Berlin, Medizinisch
Wissenschaftliche Verlagsgesellschaft, 2010: p. 7-13.
2. Varon, J., Approach to the intensive care unit (ICU), in Handbook of Critical and
Intensive Care Medicine. 2016, Springer. p. 1-10.
3. Ribeiro, L.F., et al., Microbial community profiling in intensive care units expose
limitations in current sanitary standards. Frontiers in public health, 2019. 7: p. 240
4. Vincent, J.-L., et al., The prevalence of nosocomial infection in intensive care units in
Europe: results of the European Prevalence of Infection in Intensive Care (EPIC) Study.
Jama, 1995. 274(8): p. 639-644
5. Vincent, J.-L., et al., International study of the prevalence and outcomes of infection in
intensive care units. Jama, 2009. 302(21): p. 2323-2329
6. Azim, N., et al., Prevalence and antibiotic susceptibility among gram negative bacteria
isolated from intensive care units at a tertiary care hospital in Riyadh. Saudi Arabia. J
Pure Appl Microbiol., 2019. 13: p. 201-8.
7. Le, N.K., et al., High prevalence of hospital-acquired infections caused by gram-negative
carbapenem resistant strains in Vietnamese pediatric ICUs: A multi-centre point
prevalence survey. Medicine, 2016. 95(27).
8. Siwakoti, S., et al., Incidence and outcomes of multidrug-resistant gram-negative
bacteria infections in intensive care unit from Nepal-a prospective cohort study.
Antimicrobial Resistance & Infection Control, 2018. 7(1): p. 1-8
9. Bhatta, D.R., et al., Bacterial contamination of frequently touched objects in a tertiary
care hospital of Pokhara, Nepal: how safe are our hands? Antimicrobial Resistance &
Infection Control, 2018. 7(1): p. 1-6
10. Bhatta, D.R., et al., Bacterial contamination of neonatal intensive care units: How safe
are the neonates? Antimicrobial Resistance & Infection Control, 2021. 10(1): p. 1-6
 CV of Principal investigator

Name : Sumnima Koirala

Permanent Address : Lamjung, Nepal

Nationality : Nepali

Sex : Female

Language : Nepali, English

Mobile Number : 9846723685

Email : koiralasumnima1999@gmail.com

Academic qualifications

S. Course of
Name of Institution Board Division Year
N. study

1. SLC Shree Bhairab Kali SLC Board First 2070

Higher Secondary division
School, Lamjung

2. 10+2 National School of H.S.E.B First 2073

Sciences, division
Kathmandu

3. B. Sc. Nobel College, Pokhara Running

Medical Sinamangal, University
Microbiology Kathmandu
 CV of Co-investigator

Name : Abha Baral

Permanent Address : Biratnagar, Nepal

Nationality : Nepali

Sex : Female

Language : Nepali, English

Mobile Number : 9862279393

Email : baralaabha@gmail.com

Academic qualifications

S. N. Course of study Name of Institution Board Division Year

1. SLC Eurokids Nepal, SLC Board First 2070

Biratnagar division

2. 10+2 Eurokids Nepal, H.S.E.B First 2073

Biratnagar division

3. B. Sc. Medical Nobel College, Pokhara Running

Microbiology Sinamangal, Kathmandu University
Acceptance of General Conditions and Declaration by the Principal Investigator

I, hereby, certify that the above-mentioned statements are true to the best of my knowledge; I
have read and understood the regulations of Institutional Review Committee of Manipal
College of Medical Sciences, the review of research proposal and will act inconformity with the
said regulations in all respects. I agree to accept responsibility for the scientific conduct of the
research project.
If the research is terminated, for any reason, I will notify IRC of this decision and provide the
reasons for early termination such actions. In addition, I will notify IRC in writing upon
completion of the research, and submit a copy of my research paper to IRC.

……………………………………………..
Signature of the Principal Investigator

Name:

Date: