Enteral NutritionNCT04240132
Hand Hygiene Practices and Microbial Contamination on Feeding Tubes and Other Components of Feeding Systems
A study testing Adherence to Hand Hygiene in people with Enteral Nutrition and Microbial Colonization, run by Istanbul Demiroglu Bilim University at 1 site in Turkey (Türkiye).
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Enteral Nutrition, Microbial Colonization, Adherence
- What is being tested?
- Adherence to Hand Hygiene
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 51 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 2 Jan 2020to 1 Feb 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Demiroglu Bİlim University
Istanbul, Sisli, 34360
About this study
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
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.
Read the 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
- Conditions
- Enteral Nutrition, Microbial Colonization, Adherence
- Being tested
- Adherence to Hand Hygiene
- Medical subject headings
- Communicable Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Adherence to Hand HygieneOther
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
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Adherence to Hand Hygiene |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: up to 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2020
- Study start2 Jan 2020
- Primary completion25 May 2020
- Study completion1 Feb 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Enteral NutritionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Prospective, observational and semi-experimental (mix method)
- Masking
- None (open label)
- Enrolment
- 51 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istanbul Demiroglu Bilim University
- Sponsor type
- University, hospital or other
- Collaborators
- Turkish Society of Clinical Enteral and Parenteral Nutrition
- Responsible party
- Principal investigator, Nurten Ozen, Istanbul Demiroglu Bilim University
- Investigators
- Nurten Ozen, Principal investigator, Demiroglu Bilim Üniversitesi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04240132
- Sponsor's protocol ID
- 01/2020
- Status last verified
- Mar 2021
- First submitted
- 22 Jan 2020
- Last updated
- 22 Mar 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 14994944Duckro 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.
PubMed 15710793Ho 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.
PubMed 22765960Mathus-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.
PubMed 17047178
Study at a glance
From the registry record, last updated by the sponsor on 22 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04240132
- Acronym / sponsor ID
- 01/2020
- Conditions
- Enteral Nutrition, Microbial Colonization, Adherence
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 51 participants (actual)
- Lead sponsor
- Istanbul Demiroglu Bilim UniversityUniversity, hospital or other
- Collaborators
- Turkish Society of Clinical Enteral and Parenteral Nutrition
- Study start
- 2 Jan 2020 (actual)
- Primary completion
- 25 May 2020 (actual)
- Study completion
- 1 Feb 2021 (actual)
- First posted
- 27 Jan 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Prospective, observational and semi-experimental (mix method)
| Arm | Type | Receives |
|---|---|---|
| Adherence to hand hygene | Experimental | Other: Adherence to Hand HygieneThe 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. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Adherence to Hand Hygienedetermine 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 | Other | Adherence to hand hygene |
Primary outcome
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.
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.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Mar 2021.
- Results publication: PubMed 14994944Bhalla 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 publication: PubMed 15710793Duckro 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 publication: PubMed 22765960Ho 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 publication: PubMed 17047178Mathus-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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nurten Ozen principal investigator
Demiroglu Bilim Üniversitesi
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Adherence to Hand Hygiene in people with Enteral Nutrition and Microbial Colonization, run by Istanbul Demiroglu Bilim University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adherence to hand hygiene at nurses (time frame: up to 12 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04240132, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Mar 2021.