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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04240132
Recruitment Status : Active, not recruiting
First Posted : January 27, 2020
Last Update Posted : January 29, 2020
Sponsor:
Collaborator:
Turkish Society of Clinical Enteral and Parenteral Nutrition
Information provided by (Responsible Party):
Nurten Ozen, Istanbul Demiroglu Bilim University

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.


Condition or disease Intervention/treatment Phase
Enteral Nutrition Microbial Colonization Adherence Other: Adherence to Hand Hygiene Not Applicable

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 51 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: Prospective, observational and semi-experimental (mix method)
Masking: None (Open Label)
Primary Purpose: Prevention
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
Actual Study Start Date : January 2, 2020
Estimated Primary Completion Date : April 25, 2020
Estimated Study Completion Date : June 1, 2020

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.



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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04240132


Locations
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Turkey
Demiroglu Bİlim University
Istanbul, Sisli, Turkey, 34360
Sponsors and Collaborators
Istanbul Demiroglu Bilim University
Turkish Society of Clinical Enteral and Parenteral Nutrition
Investigators
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Principal Investigator: Nurten Ozen Demiroglu Bilim Üniversitesi
Publications of Results:
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Responsible Party: Nurten Ozen, Assistant Professor, Istanbul Demiroglu Bilim University
ClinicalTrials.gov Identifier: NCT04240132    
Other Study ID Numbers: 01/2020
First Posted: January 27, 2020    Key Record Dates
Last Update Posted: January 29, 2020
Last Verified: January 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Communicable Diseases
Infection