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

March 19, 2021 updated by: Nurten Ozen, Istanbul Demiroglu Bilim University

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Study Type

Interventional

Enrollment (Actual)

51

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
    • Sisli
      • Istanbul, Sisli, Turkey, 34360
        • Demiroglu Bilim University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Adherence to hand hygene
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.
Other: Adherence to Hand Hygiene
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Adherence to hand hygiene at nurses
Time Frame: up to 12 weeks
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.
up to 12 weeks
Adherence to hand hygiene at auxillary service staff
Time Frame: up to 12 weeks
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.
up to 12 weeks
Microbial contamination rate
Time Frame: up to 12 weeks
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.
up to 12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Istanbul Demiroglu Bilim University

Collaborators

Turkish Society of Clinical Enteral and Parenteral Nutrition

Investigators

  • Principal Investigator: Nurten Ozen, Demiroglu Bilim Üniversitesi

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

January 2, 2020

Primary Completion (ACTUAL)

May 25, 2020

Study Completion (ACTUAL)

February 1, 2021

Study Registration Dates

First Submitted

January 22, 2020

First Submitted That Met QC Criteria

January 22, 2020

First Posted (ACTUAL)

January 27, 2020

Study Record Updates

Last Update Posted (ACTUAL)

March 22, 2021

Last Update Submitted That Met QC Criteria

March 19, 2021

Last Verified

March 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 01/2020

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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