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Hand Hygiene Practices and Microbial Contamination on Feeding Tubes and Other Components of Feeding Systems

Primary Purpose

Enteral Nutrition, Microbial Colonization, Adherence

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Adherence to Hand Hygiene
Sponsored by
Istanbul Demiroglu Bilim University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Enteral Nutrition

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Patients who are 18 years old or older
  • Being enteral fed via nasogastric tube at least for three days
  • Patients' relatives approve to be enrolled are going to be included in the study
  • Nurses and other healthcare providers who work in the ICU

Exclusion Criteria:

  • Patients who are being under respiratory, contact or droplet isolation according to definitions of Centers for Disease Control and Prevention
  • Patients' relatives do not approve enrollment

Sites / Locations

  • Demiroglu Bİlim University

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Adherence to hand hygene

Arm Description

The face-to-face interview will be held in an appropriate empty room in the intensive care unit (ICU) in a time schedule suitable for the healthcare workers. The researchers will provide training to healthcare workers working in the ICU in accordance with the World Helath Organization (WHO) Hand Hygiene Guidelines. One day training on nursing interventions related to enteral feeding treatment will be provided to nurses and their questions will be answered. At the end of the each training, trainees will be given a data collection form to assess the effectiveness of the training.

Outcomes

Primary Outcome Measures

Adherence to hand hygiene at nurses
Hand Hygiene Belief Scale will be used. The scale consists of 22 items on individual's beliefs on hand hygiene and perceptions on the importance of hand hygiene. The lowest total score is 22 and the highest total score is 110. Higher scores can be interpreted as having positive beliefs on hand hygiene.
Adherence to hand hygiene at auxillary service staff
Scale for Hand Hygiene Compliance of Auxillary Service Staff will be used. It consist of 21 items and has 4 dimensions; "After contact with patient" (6 items), "Before contact with patient" (6 items), "risk of contact with blood and body fluids" (4 items), "after contact with patient environment" (5 items). The lowest total score is 0 and the highest total score is 84. Higher scores represent higher adherence to hand hygiene.
Microbial contamination rate
The samples for microbial analysis will be collected from internal and external surface of the NGT and other components of the feeding system by sterile swaps from all of the participant patients.

Secondary Outcome Measures

Full Information

First Posted
January 22, 2020
Last Updated
March 19, 2021
Sponsor
Istanbul Demiroglu Bilim University
Collaborators
Turkish Society of Clinical Enteral and Parenteral Nutrition
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1. Study Identification

Unique Protocol Identification Number
NCT04240132
Brief Title
Hand Hygiene Practices and Microbial Contamination on Feeding Tubes and Other Components of Feeding Systems
Official Title
Relation Between Adherence to Hand Hygiene Practices by Healthcare Providers Working in Intensive Care Unit and Microbial Contamination on Feeding Tubes and Other Components of Feeding Systems
Study Type
Interventional

2. Study Status

Record Verification Date
March 2021
Overall Recruitment Status
Completed
Study Start Date
January 2, 2020 (Actual)
Primary Completion Date
May 25, 2020 (Actual)
Study Completion Date
February 1, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Istanbul Demiroglu Bilim University
Collaborators
Turkish Society of Clinical Enteral and Parenteral Nutrition

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
Enteral feeding tube (EFT) and component of feeding systems can serve as a reservoir of microorganisms, and the main reason is inappropriate hand hygiene practices. The aim of the project is to determine colonization of microorganisms on the EFT and other components and assess the relation between colonization and adherence to hand hygiene practices by healthcare workers in the intensive care unit. This prospective, observational and semi-experimental study will be conducted in one year. The project will be completed with healthcare workers and 51 patients who are feeding enteral route via nasogastric tube at least for three days. The researchers will provide training to healthcare workers in accordance with the World Health Organization (WHO) Hand Hygiene Guidelines. Hand hygiene behaviors of the participants will be observed and the question forms will be filled before and after training by researchers. The samples for microbial analysis will be collected from the EFT by sterile swaps.
Detailed Description
Enteral Feeding Tube (EFT) such as Nasogastric Tube (NGT), Duodenal/Jejunal Tube and Gastrostomy Tube are frequently used in Intensive Care Unit (ICU). However, EFT is generally an omitted/neglected source of contamination. EFT can serve as a reservoir of Methicillin Resistant Staphylococcus Aureus (MRSA), which multiplies the risk of mortality by 2-2.5 times, for microorganism transmission. As a consequence of contamination of EFT, microorganisms, that may be manifest with the symptoms such as abdominal pain, distention, nausea, vomiting, diarrhea, may reproduce and progress to bacteremia, septicemia and even to death. In some studies, it is observed that there is a relation between the contamination on the external surface of EFT and contamination on the entry of EFT (hub), and it is also reported that the rate of contamination on the hub of the EFT and the environment of the patient is quite high. ICU nurses are responsible for sustaining safe and secure feeding, medication and fluid replacement of patients. Also, they provide enteral feeding products to patients as they are prescribed. Personnel training, proper processing procedures and developed enteral feeding protocols are shown to decrease the incidence of bacterial contamination on the enteral feeding tube

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Enteral Nutrition, Microbial Colonization, Adherence

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Prospective, observational and semi-experimental (mix method)
Masking
None (Open Label)
Allocation
N/A
Enrollment
51 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Adherence to hand hygene
Arm Type
Experimental
Arm Description
The face-to-face interview will be held in an appropriate empty room in the intensive care unit (ICU) in a time schedule suitable for the healthcare workers. The researchers will provide training to healthcare workers working in the ICU in accordance with the World Helath Organization (WHO) Hand Hygiene Guidelines. One day training on nursing interventions related to enteral feeding treatment will be provided to nurses and their questions will be answered. At the end of the each training, trainees will be given a data collection form to assess the effectiveness of the training.
Intervention Type
Other
Intervention Name(s)
Adherence to Hand Hygiene
Intervention Description
determine the colonization of microorganisms due to microbial reproduction on the external surface of the distal end of the enteral feeding tube (EFT), hub of the EFT and other feeding system components and assess the relation between the colonization and adherence to hand hygiene practices by nurses and other healthcare workers
Primary Outcome Measure Information:
Title
Adherence to hand hygiene at nurses
Description
Hand Hygiene Belief Scale will be used. The scale consists of 22 items on individual's beliefs on hand hygiene and perceptions on the importance of hand hygiene. The lowest total score is 22 and the highest total score is 110. Higher scores can be interpreted as having positive beliefs on hand hygiene.
Time Frame
up to 12 weeks
Title
Adherence to hand hygiene at auxillary service staff
Description
Scale for Hand Hygiene Compliance of Auxillary Service Staff will be used. It consist of 21 items and has 4 dimensions; "After contact with patient" (6 items), "Before contact with patient" (6 items), "risk of contact with blood and body fluids" (4 items), "after contact with patient environment" (5 items). The lowest total score is 0 and the highest total score is 84. Higher scores represent higher adherence to hand hygiene.
Time Frame
up to 12 weeks
Title
Microbial contamination rate
Description
The samples for microbial analysis will be collected from internal and external surface of the NGT and other components of the feeding system by sterile swaps from all of the participant patients.
Time Frame
up to 12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Patients who are 18 years old or older Being enteral fed via nasogastric tube at least for three days Patients' relatives approve to be enrolled are going to be included in the study Nurses and other healthcare providers who work in the ICU Exclusion Criteria: Patients who are being under respiratory, contact or droplet isolation according to definitions of Centers for Disease Control and Prevention Patients' relatives do not approve enrollment
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nurten Ozen
Organizational Affiliation
Demiroglu Bilim Üniversitesi
Official's Role
Principal Investigator
Facility Information:
Facility Name
Demiroglu Bİlim University
City
Istanbul
State/Province
Sisli
ZIP/Postal Code
34360
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
14994944
Citation
Bhalla A, Pultz NJ, Gries DM, Ray AJ, Eckstein EC, Aron DC, Donskey CJ. Acquisition of nosocomial pathogens on hands after contact with environmental surfaces near hospitalized patients. Infect Control Hosp Epidemiol. 2004 Feb;25(2):164-7. doi: 10.1086/502369.
Results Reference
result
PubMed Identifier
15710793
Citation
Duckro AN, Blom DW, Lyle EA, Weinstein RA, Hayden MK. Transfer of vancomycin-resistant enterococci via health care worker hands. Arch Intern Med. 2005 Feb 14;165(3):302-7. doi: 10.1001/archinte.165.3.302.
Results Reference
result
PubMed Identifier
22765960
Citation
Ho SS, Tse MM, Boost MV. Effect of an infection control programme on bacterial contamination of enteral feed in nursing homes. J Hosp Infect. 2012 Sep;82(1):49-55. doi: 10.1016/j.jhin.2012.05.002. Epub 2012 Jul 4.
Results Reference
result
PubMed Identifier
17047178
Citation
Mathus-Vliegen EM, Bredius MW, Binnekade JM. Analysis of sites of bacterial contamination in an enteral feeding system. JPEN J Parenter Enteral Nutr. 2006 Nov-Dec;30(6):519-25. doi: 10.1177/0148607106030006519.
Results Reference
result

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Hand Hygiene Practices and Microbial Contamination on Feeding Tubes and Other Components of Feeding Systems

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