Intensive CareNCT05790291
Drug Administration From Enteral Nutrition Tube
A study testing Checklist in people with Intensive Care, run by Emel Külekçi at 1 site in Turkey (Türkiye).
Trial summary
Enteral nutrition protocols are applied in patients who do not have gastrointestinal dysfunction but in whom oral feeding is contraindicated. In these patients, where drug use is also necessary but alternative drug administration routes are not possible, drugs can be given to the patient through enteral nutrition… Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Intensive Care
- What is being tested?
- Checklist
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 69 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Mar 2022to 15 Jun 2022
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Being an intensive care nurse
- Have experience in administering enteral medication
- Administering enteral medication to an adult patient
- Agree to participate in the research
Who cannot join
- Administering enteral medication to a patient with fluid restriction
- Change of position
- Wanting to leave research
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Sağlık Bilimleri Üniversitesi
Ankara, Keçiören, 06210
About this study
Official title: The Effect Of The Check List Developed For Drug Administration From Enteral Nutrition Tube On Administration Errors
Enteral nutrition protocols are applied in patients who do not have gastrointestinal dysfunction but in whom oral feeding is contraindicated. In these patients, where drug use is also necessary but alternative drug administration routes are not possible, drugs can be given to the patient through enteral nutrition tubes. However, there are studies reporting errors and complications during drug administration from the enteral nutrition tube. With the planned thesis study, it is aimed to develop an evidence-based checklist and to reduce the rate of errors and complications in drug administration through enteral feeding tube with this checklist.
Read the detailed description
Enteral nutrition protocols are applied in patients who do not have gastrointestinal dysfunction but in whom oral feeding is contraindicated. In these patients, where drug use is also necessary but alternative drug administration routes are not possible, drugs can be given to the patient through enteral nutrition tubes.
When adding drugs to parenteral nutrition admixtures or using concomitant drugs from the same catheter, it has become a general rule to check for drug incompatibility. The same level of care is not taken in drug administration from the enteral nutrition tube. There are studies reporting errors and complications in enteral drug administration in the literature Today, one of the most important parts of corporate culture in healthcare is patient safety. Patient safety is all of the measures taken by health institutions and employees in these institutions in order to prevent the harm that health care services may cause to individuals. The main goal here is; It is the establishment of a system that will protect the patient from possible harm and eliminate the possibility of error due to errors that will prevent the occurrence of errors during care delivery.
The checklists used in recent years are also an evidence-based practice list and have become one of the effective methods used to prevent errors and reduce complications. A checklist standardizes the process, streamlines maintenance delivery, and improves performance to ensure all actions are covered. The checklist allows cross-checking what was done and in what order. These reassurances are important in situations where time is short and distractions.
With this study, it is aimed to develop an evidence-based checklist and to reduce the rate of errors and complications in drug administration through enteral feeding tube with this checklist.
- Conditions
- Intensive Care
- Being tested
- Checklist
- Keywords
- Enteral Tube, Enteral Drug Administration, Nurse, Medication Errors, Checklist
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ChecklistOther
the experimental group will practice using the checklist
| Study group | Role | What they receive |
|---|---|---|
| checklist | Experimental | checklist Receives: Other: Checklist |
| no intervention | No intervention | no intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in enteral drug administration error rates of nurses with an interval of 2 months
First, the error rates of 69 nurses during enteral drug administration were calculated.
Enteral medication was administered for approximately one month with the next intervention group (n=34) checklist. Finally, the error rates of 69 nurses during enteral drug administration were recalculated.
Error rates were determined with a 19-item observation formula. Name of the form; Medication from Enteral Feeding Tube Observation Form for Applications The lowest error rate is 0%, the highest error rate is 100%.
Measured: baseline and month 2
Secondary outcomes (1)
Change in enteral drug administration knowledge of nurses with an interval of 2 months
First, the knowledge levels of 69 nurses on enteral drug administration were calculated.
Then the intervention group (n=34) administered enteral medication for approximately one month along with the checklist. Finally, the knowledge levels of 69 nurses on enteral drug administration were recalculated.
Knowledge levels were determined with a 20-item information form. Name of the form; It is an Information Evaluation Form for Drug Administrations from Enteral Feeding Tube.
The lowest score is 0, the highest score is 100.
Measured: baseline and month 2
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Mar 2023
- Study start15 Mar 2022
- Primary completion15 May 2022
- Study completion15 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (11)Papers the sponsor has linked to this study.
- Other trials for Intensive CareStudies 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
- Randomised
- Intervention model
- Parallel groups
- Model description
- randomized control
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 69 participants (actual)
Sponsor and investigators
- Lead sponsor
- Emel Külekçi
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Emel Külekçi, Saglik Bilimleri Universitesi Gulhane Tip Fakultesi
- Investigators
- EMEL KÜLEKCİ, Principal investigator, PhD student
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05790291
- Sponsor's protocol ID
- 2021/29
- Status last verified
- Mar 2023
- First submitted
- 16 Feb 2023
- Last updated
- 30 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Demirkan K, Ekincioğlu AB. Enteral Beslenme Tüpünden İlaç Uygulanmasında İlaç Dozaj Şekillerinin Önemi. Journal of the Turkish Society of Intensive Care/Türk Yogun Bakim Dernegi Dergisi. 2016;14(1):1-8.
Ekincioglu AB, Demirkan K. Clinical nutrition and drug interactions. Ulus Cerrahi Derg. 2013 Nov 14;29(4):177-86. doi: 10.5152/UCD.2013.112013. eCollection 2013.
PubMed 25931873Abu Hdaib N, Albsoul-Younes A, Wazaify M. Oral medications administration through enteral feeding tube: Clinical pharmacist-led educational intervention to improve knowledge of Intensive care units' nurses at Jordan University Hospital. Saudi Pharm J. 2021 Feb;29(2):134-142. doi: 10.1016/j.jsps.2020.12.015. Epub 2021 Jan 7.
PubMed 33679176Sari D, Kadifeli D, Akbiyik A, Taskiran N. Intensive care unit nurses' knowledge of medication administration via enteral tubes. Nurs Crit Care. 2018 May;23(3):141-146. doi: 10.1111/nicc.12335. Epub 2018 Feb 8.
PubMed 29424127Çelik S, Demiray Y, Tuğrul A, Köymen H, Coşkun Y, Doğru Ö, et al. Yoğun bakım hemşirelerinin enteral tüp aracılığıyla ilaç uygulamalarının değerlendirilmesi. Çağdaş Tıp Dergisi. 2014;4(1):18-25.
Emami S, Hamishehkar H, Mahmoodpoor A, Mashayekhi S, Asgharian P. Errors of oral medication administration in a patient with enteral feeding tube. J Res Pharm Pract. 2012 Jul;1(1):37-40. doi: 10.4103/2279-042X.99677.
PubMed 24991587Özkan D, Yavuz Van Giersbergen M. Güvenli Cerrahi Kontrol Listesi Konusunda Ameliyathane Ekibinin Düşüncelerinin İncelenmesi. Turkiye Klinikleri J Surg Nurs-Special Topics Türkiye Klinikleri Cerrahi Hastalıkları Hemşireliği-Güvenli Cerrahi Uygulamaları Özel Sayısı. 2016;2(3):22-8
Winters BD, Gurses AP, Lehmann H, Sexton JB, Rampersad CJ, Pronovost PJ. Clinical review: checklists - translating evidence into practice. Crit Care. 2009;13(6):210. doi: 10.1186/cc7792. Epub 2009 Dec 31.
PubMed 20064195Bankhead R, Boullata J, Brantley S, Corkins M, Guenter P, Krenitsky J, Lyman B, Metheny NA, Mueller C, Robbins S, Wessel J; A.S.P.E.N. Board of Directors. Enteral nutrition practice recommendations. JPEN J Parenter Enteral Nutr. 2009 Mar-Apr;33(2):122-67. doi: 10.1177/0148607108330314. Epub 2009 Jan 26. No abstract available.
PubMed 19171692Boullata JI, Carrera AL, Harvey L, Escuro AA, Hudson L, Mays A, McGinnis C, Wessel JJ, Bajpai S, Beebe ML, Kinn TJ, Klang MG, Lord L, Martin K, Pompeii-Wolfe C, Sullivan J, Wood A, Malone A, Guenter P; ASPEN Safe Practices for Enteral Nutrition Therapy Task Force, American Society for Parenteral and Enteral Nutrition. ASPEN Safe Practices for Enteral Nutrition Therapy [Formula: see text]. JPEN J Parenter Enteral Nutr. 2017 Jan;41(1):15-103. doi: 10.1177/0148607116673053. Epub 2016 Nov 5.
PubMed 27815525Bischoff SC, Austin P, Boeykens K, Chourdakis M, Cuerda C, Jonkers-Schuitema C, Lichota M, Nyulasi I, Schneider SM, Stanga Z, Pironi L. ESPEN guideline on home enteral nutrition. Clin Nutr. 2020 Jan;39(1):5-22. doi: 10.1016/j.clnu.2019.04.022. Epub 2019 May 30.
PubMed 31255350
Study at a glance
From the registry record, last updated by the sponsor on 30 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect Of The Check List Developed For Drug Administration From Enteral Nutrition Tube On Administration Errors
- ClinicalTrials.gov ID
- NCT05790291
- Acronym / sponsor ID
- 2021/29
- Conditions
- Intensive Care
- Keywords
- Enteral Tube, Enteral Drug Administration, Nurse, Medication Errors, Checklist
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 69 participants (actual)
- Lead sponsor
- Emel KülekçiUniversity, hospital or other
- Study start
- 15 Mar 2022 (actual)
- Primary completion
- 15 May 2022 (actual)
- Study completion
- 15 Jun 2022 (actual)
- First posted
- 30 Mar 2023 (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 nutrition protocols are applied in patients who do not have gastrointestinal dysfunction but in whom oral feeding is contraindicated. In these patients, where drug use is also necessary but alternative drug administration routes are not possible, drugs can be given to the patient through enteral nutrition tubes. However, there are studies reporting errors and complications during drug administration from the enteral nutrition tube. With the planned thesis study, it is aimed to develop an evidence-based checklist and to reduce the rate of errors and complications in drug administration through enteral feeding tube with this checklist.
Detailed description
Enteral nutrition protocols are applied in patients who do not have gastrointestinal dysfunction but in whom oral feeding is contraindicated. In these patients, where drug use is also necessary but alternative drug administration routes are not possible, drugs can be given to the patient through enteral nutrition tubes.
When adding drugs to parenteral nutrition admixtures or using concomitant drugs from the same catheter, it has become a general rule to check for drug incompatibility. The same level of care is not taken in drug administration from the enteral nutrition tube. There are studies reporting errors and complications in enteral drug administration in the literature Today, one of the most important parts of corporate culture in healthcare is patient safety. Patient safety is all of the measures taken by health institutions and employees in these institutions in order to prevent the harm that health care services may cause to individuals. The main goal here is; It is the establishment of a system that will protect the patient from possible harm and eliminate the possibility of error due to errors that will prevent the occurrence of errors during care delivery.
The checklists used in recent years are also an evidence-based practice list and have become one of the effective methods used to prevent errors and reduce complications. A checklist standardizes the process, streamlines maintenance delivery, and improves performance to ensure all actions are covered. The checklist allows cross-checking what was done and in what order. These reassurances are important in situations where time is short and distractions.
With this study, it is aimed to develop an evidence-based checklist and to reduce the rate of errors and complications in drug administration through enteral feeding tube with this checklist.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- randomized control
| Arm | Type | Receives |
|---|---|---|
| checklist | Experimental | Other: Checklistchecklist |
| no intervention | No intervention | –no intervention |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- Being an intensive care nurse
- Have experience in administering enteral medication
- Administering enteral medication to an adult patient
- Agree to participate in the research
Key exclusion criteria (3 listed)
- Administering enteral medication to a patient with fluid restriction
- Change of position
- Wanting to leave research
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 |
|---|---|---|
| Checklistthe experimental group will practice using the checklist | Other | checklist |
Primary outcome
Change in enteral drug administration error rates of nurses with an interval of 2 months
Time frame: baseline and month 2
First, the error rates of 69 nurses during enteral drug administration were calculated. Enteral medication was administered for approximately one month with the next intervention group (n=34) checklist. Finally, the error rates of 69 nurses during enteral drug administration were recalculated. Error rates were determined with a 19-item observation formula. Name of the form; Medication from Enteral Feeding Tube Observation Form for Applications The lowest error rate is 0%, the highest error rate is 100%.
1 secondary outcome
Change in enteral drug administration knowledge of nurses with an interval of 2 months
Time frame: baseline and month 2
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 30 Mar 2023.
- BackgroundDemirkan K, Ekincioğlu AB. Enteral Beslenme Tüpünden İlaç Uygulanmasında İlaç Dozaj Şekillerinin Önemi. Journal of the Turkish Society of Intensive Care/Türk Yogun Bakim Dernegi Dergisi. 2016;14(1):1-8.
- Background: PubMed 25931873Ekincioglu AB, Demirkan K. Clinical nutrition and drug interactions. Ulus Cerrahi Derg. 2013 Nov 14;29(4):177-86. doi: 10.5152/UCD.2013.112013. eCollection 2013.
- Background: PubMed 33679176Abu Hdaib N, Albsoul-Younes A, Wazaify M. Oral medications administration through enteral feeding tube: Clinical pharmacist-led educational intervention to improve knowledge of Intensive care units' nurses at Jordan University Hospital. Saudi Pharm J. 2021 Feb;29(2):134-142. doi: 10.1016/j.jsps.2020.12.015. Epub 2021 Jan 7.
- Background: PubMed 29424127Sari D, Kadifeli D, Akbiyik A, Taskiran N. Intensive care unit nurses' knowledge of medication administration via enteral tubes. Nurs Crit Care. 2018 May;23(3):141-146. doi: 10.1111/nicc.12335. Epub 2018 Feb 8.
- BackgroundÇelik S, Demiray Y, Tuğrul A, Köymen H, Coşkun Y, Doğru Ö, et al. Yoğun bakım hemşirelerinin enteral tüp aracılığıyla ilaç uygulamalarının değerlendirilmesi. Çağdaş Tıp Dergisi. 2014;4(1):18-25.
- Background: PubMed 24991587Emami S, Hamishehkar H, Mahmoodpoor A, Mashayekhi S, Asgharian P. Errors of oral medication administration in a patient with enteral feeding tube. J Res Pharm Pract. 2012 Jul;1(1):37-40. doi: 10.4103/2279-042X.99677.
- BackgroundÖzkan D, Yavuz Van Giersbergen M. Güvenli Cerrahi Kontrol Listesi Konusunda Ameliyathane Ekibinin Düşüncelerinin İncelenmesi. Turkiye Klinikleri J Surg Nurs-Special Topics Türkiye Klinikleri Cerrahi Hastalıkları Hemşireliği-Güvenli Cerrahi Uygulamaları Özel Sayısı. 2016;2(3):22-8
- Background: PubMed 20064195Winters BD, Gurses AP, Lehmann H, Sexton JB, Rampersad CJ, Pronovost PJ. Clinical review: checklists - translating evidence into practice. Crit Care. 2009;13(6):210. doi: 10.1186/cc7792. Epub 2009 Dec 31.
- Background: PubMed 19171692Bankhead R, Boullata J, Brantley S, Corkins M, Guenter P, Krenitsky J, Lyman B, Metheny NA, Mueller C, Robbins S, Wessel J; A.S.P.E.N. Board of Directors. Enteral nutrition practice recommendations. JPEN J Parenter Enteral Nutr. 2009 Mar-Apr;33(2):122-67. doi: 10.1177/0148607108330314. Epub 2009 Jan 26. No abstract available.
- Background: PubMed 27815525Boullata JI, Carrera AL, Harvey L, Escuro AA, Hudson L, Mays A, McGinnis C, Wessel JJ, Bajpai S, Beebe ML, Kinn TJ, Klang MG, Lord L, Martin K, Pompeii-Wolfe C, Sullivan J, Wood A, Malone A, Guenter P; ASPEN Safe Practices for Enteral Nutrition Therapy Task Force, American Society for Parenteral and Enteral Nutrition. ASPEN Safe Practices for Enteral Nutrition Therapy [Formula: see text]. JPEN J Parenter Enteral Nutr. 2017 Jan;41(1):15-103. doi: 10.1177/0148607116673053. Epub 2016 Nov 5.
- Background: PubMed 31255350Bischoff SC, Austin P, Boeykens K, Chourdakis M, Cuerda C, Jonkers-Schuitema C, Lichota M, Nyulasi I, Schneider SM, Stanga Z, Pironi L. ESPEN guideline on home enteral nutrition. Clin Nutr. 2020 Jan;39(1):5-22. doi: 10.1016/j.clnu.2019.04.022. Epub 2019 May 30.
- BAPENLink provided by the sponsor.
- 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.
EMEL KÜLEKCİ principal investigator
PhD student
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Checklist in people with Intensive Care, run by Emel Külekçi 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 3 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 30 Mar 2023. 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?
Change in enteral drug administration error rates of nurses with an interval of 2 months (time frame: baseline and month 2). 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 NCT05790291, which also lists 11 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 30 Mar 2023.