NCT04240132

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
51

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2020

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 2, 2020

Completed
20 days until next milestone

First Submitted

Initial submission to the registry

January 22, 2020

Completed
5 days until next milestone

First Posted

Study publicly available on registry

January 27, 2020

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 25, 2020

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2021

Completed
Last Updated

March 22, 2021

Status Verified

March 1, 2021

Enrollment Period

5 months

First QC Date

January 22, 2020

Last Update Submit

March 19, 2021

Conditions

Outcome Measures

Primary Outcomes (3)

  • 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.

    up to 12 weeks

  • 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.

    up to 12 weeks

  • 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.

    up to 12 weeks

Study Arms (1)

Adherence to hand hygene

EXPERIMENTAL

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

Interventions

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

Adherence to hand hygene

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Demiroglu Bİlim University

Istanbul, Sisli, 34360, Turkey (Türkiye)

Location

Related Publications (4)

  • 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.

  • 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.

  • 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.

  • 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.

MeSH Terms

Conditions

Communicable Diseases

Condition Hierarchy (Ancestors)

InfectionsDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Nurten Ozen

    Demiroglu Bilim Üniversitesi

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Model Details: Prospective, observational and semi-experimental (mix method)
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

January 22, 2020

First Posted

January 27, 2020

Study Start

January 2, 2020

Primary Completion

May 25, 2020

Study Completion

February 1, 2021

Last Updated

March 22, 2021

Record last verified: 2021-03

Data Sharing

IPD Sharing
Will not share

Locations