Enteral NutritionNCT05900323
Enteral Nutrition Guidelines and Patients' Outcomes
A study testing enteral nutrition guidelines in people with Enteral Nutrition, run by Mansoura University.
Trial summary
Critically ill patients often exhibit a hypermetabolic state and increased energy requirements due to their critical illnesses. Those patients cannot meet their nutritional requirements through oral feeding. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Enteral Nutrition
- What is being tested?
- enteral nutrition guidelines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 68 participants
- Where
- No sites listed yet
- Study dates
- 1 Sep 2023to 30 Jun 2024
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult patients ≥ 18 years old.
- Hemodynamically stable patients.
- Patients who are unable to maintain volitional oral intake within 24 hours of admission.
Who cannot join
- Signs of feeding intolerance (nausea, vomiting, diarrhea, or high gastric residual volume).
- Contraindications to EN such as active bleeding, bowel obstruction, bowel ischemia, or paralytic ileus.
- Signs of clinical shock (low blood pressure, rapid breathing, rapid weak pulse, and decreased urine output).
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Effect of Implementing Enteral Nutrition Guidelines on Critical Care Nurses' Practice and Patients' Outcomes
Critically ill patients often exhibit a hypermetabolic state and increased energy requirements due to their critical illnesses. Those patients cannot meet their nutritional requirements through oral feeding. Therefore, the initiation of enteral nutrition (EN) is an essential intervention to fulfill the body's dietary and physiological requirements. Despite advancements in the techniques and equipment used for EN, inadequate nutritional intake is a significant issue for CIPs. It requires special attention to prevent muscle wasting and overfeeding. Critical care nurses have a key role in applying the proper nutritional care for CIPs. They are responsible for inserting and maintaining the feeding tube, delivering the feeds, and avoiding complications associated with EN.
Read the detailed description
Enteral nutrition is a proactive therapeutic strategy that can be provided by nasogastric or nasoduodenal tubes, gastrostomy, and jejunostomy. It is indicated for the patient who has the digestive capability but is unable to consume enough feeding by mouth. Patients with profound anorexia or severe stress that greatly increases their nutritional needs also require EN. On the other hand, EN is contraindicated for patients with refractory diarrhea, vomiting, bowel obstruction, and when the gastrointestinal tract is not intact.
Despite advancements in the techniques and equipment used for EN, inadequate nutritional intake is a significant issue for CIPs. It requires special attention to prevent muscle wasting and overfeeding. Underfeeding has detrimental effects on patients' clinical outcomes such as delayed wound healing, increased infectious complications, prolonged mechanical ventilation and length of stay in the ICU, and higher mortality rates. Adequate patient nutrition depends on specific interventions or protocols used for planning, initiation, and detection of its complications. Therefore, various nutritional support guidelines are being continuously developed and enriched to help clinical workers improve their nutritional care practice and patients' outcomes.
While the process of administering EN may appear less complex compared with parenteral nutrition, serious complications, and death can result due to potential adverse events occurring throughout the process of ordering, administering, and monitoring EN. These events include reports of metabolic abnormalities, bronchopulmonary aspiration, feeding intolerance, and drug-nutrient interactions.
Because of the significant effects of nursing care on all aspects of EN delivery and management, accurate feeding procedure and avoidance of its associated complications should be considered as a crucial component of nurses' practice. An extensive review of the literature revealed that the patient's clinical outcomes were not evaluated in most studies in Egypt; however, CIPs have a high risk of developing malnutrition or feeding intolerance which is associated with worse clinical outcomes. This inspired us to carry out this study to cover this area.
- Conditions
- Enteral Nutrition
- Being tested
- enteral nutrition guidelines
- Keywords
- Enteral nutrition guidelines, Critical care nurses' practice, Patients' outcomes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
enteral nutrition guidelinesCombination product
Also called prokinetic agent
The nurses will be educated about the enteral nutrition guidelines. Then they will apply these guidelines on the participants during enteral nutrition procedure. After conducting the guidelines, the researcher will assess the effect of the guidelines on patients' outcomes.
| Study group | Role | What they receive |
|---|---|---|
| Enteral Nutrition Guidelines Group | Experimental | It will include 34 patients who will receive enteral nutrition guidelines. Receives: Combination Product: enteral nutrition guidelines |
| Routine Enteral Nutrition Unit Care Group | No intervention | It will include 34 patients who will receive routine enteral nutrition unit care. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Signs of feeding intolerance assessment
Absence of vomiting, diarrhea, constipation, abdominal distention, and Normal gastric residual volume.
Measured: Signs of feeding intolerance will be assessed for seven days.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2023
- Study start1 Sep 2023 (estimated)
- Primary completion30 Jan 2024 (estimated)
- Study completion30 Jun 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Enteral NutritionStudies of the same condition, open and under way.
- More trials run by Mansoura UniversityThe sponsor's other registered studies.
- 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 68 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mansoura University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, sara Elsayed Ali Hegazy, Mansoura University
- Investigators
- Sara EA Hegazy, Principal investigator, Faculty of Nursing, Mansoura University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05900323
- Sponsor's protocol ID
- Enteral Nutrition
- Status last verified
- Jun 2023
- First submitted
- 29 May 2023
- Last updated
- 12 Jun 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Implementing Enteral Nutrition Guidelines on Critical Care Nurses' Practice and Patients' Outcomes
- ClinicalTrials.gov ID
- NCT05900323
- Acronym / sponsor ID
- Enteral Nutrition
- Conditions
- Enteral Nutrition
- Keywords
- Enteral nutrition guidelines, Critical care nurses' practice, Patients' outcomes
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 68 participants (estimated)
- Lead sponsor
- Mansoura UniversityUniversity, hospital or other
- Study start
- 1 Sep 2023 (estimated)
- Primary completion
- 30 Jan 2024 (estimated)
- Study completion
- 30 Jun 2024 (estimated)
- First posted
- 12 Jun 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.
Critically ill patients often exhibit a hypermetabolic state and increased energy requirements due to their critical illnesses. Those patients cannot meet their nutritional requirements through oral feeding. Therefore, the initiation of enteral nutrition (EN) is an essential intervention to fulfill the body's dietary and physiological requirements. Despite advancements in the techniques and equipment used for EN, inadequate nutritional intake is a significant issue for CIPs. It requires special attention to prevent muscle wasting and overfeeding. Critical care nurses have a key role in applying the proper nutritional care for CIPs. They are responsible for inserting and maintaining the feeding tube, delivering the feeds, and avoiding complications associated with EN.
Detailed description
Enteral nutrition is a proactive therapeutic strategy that can be provided by nasogastric or nasoduodenal tubes, gastrostomy, and jejunostomy. It is indicated for the patient who has the digestive capability but is unable to consume enough feeding by mouth. Patients with profound anorexia or severe stress that greatly increases their nutritional needs also require EN. On the other hand, EN is contraindicated for patients with refractory diarrhea, vomiting, bowel obstruction, and when the gastrointestinal tract is not intact.
Despite advancements in the techniques and equipment used for EN, inadequate nutritional intake is a significant issue for CIPs. It requires special attention to prevent muscle wasting and overfeeding. Underfeeding has detrimental effects on patients' clinical outcomes such as delayed wound healing, increased infectious complications, prolonged mechanical ventilation and length of stay in the ICU, and higher mortality rates. Adequate patient nutrition depends on specific interventions or protocols used for planning, initiation, and detection of its complications. Therefore, various nutritional support guidelines are being continuously developed and enriched to help clinical workers improve their nutritional care practice and patients' outcomes.
While the process of administering EN may appear less complex compared with parenteral nutrition, serious complications, and death can result due to potential adverse events occurring throughout the process of ordering, administering, and monitoring EN. These events include reports of metabolic abnormalities, bronchopulmonary aspiration, feeding intolerance, and drug-nutrient interactions.
Because of the significant effects of nursing care on all aspects of EN delivery and management, accurate feeding procedure and avoidance of its associated complications should be considered as a crucial component of nurses' practice. An extensive review of the literature revealed that the patient's clinical outcomes were not evaluated in most studies in Egypt; however, CIPs have a high risk of developing malnutrition or feeding intolerance which is associated with worse clinical outcomes. This inspired us to carry out this study to cover this area.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Enteral Nutrition Guidelines Group | Experimental | Combination Product: enteral nutrition guidelinesIt will include 34 patients who will receive enteral nutrition guidelines. |
| Routine Enteral Nutrition Unit Care Group | No intervention | –It will include 34 patients who will receive routine enteral nutrition unit care. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Adult patients ≥ 18 years old.
- Hemodynamically stable patients.
- Patients who are unable to maintain volitional oral intake within 24 hours of admission.
Key exclusion criteria (3 listed)
- Signs of feeding intolerance (nausea, vomiting, diarrhea, or high gastric residual volume).
- Contraindications to EN such as active bleeding, bowel obstruction, bowel ischemia, or paralytic ileus.
- Signs of clinical shock (low blood pressure, rapid breathing, rapid weak pulse, and decreased urine output).
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 |
|---|---|---|
| enteral nutrition guidelinesAlso: prokinetic agentThe nurses will be educated about the enteral nutrition guidelines. Then they will apply these guidelines on the participants during enteral nutrition procedure. After conducting the guidelines, the researcher will assess the effect of the guidelines on patients' outcomes. | Combination product | Enteral Nutrition Guidelines Group |
Primary outcome
Signs of feeding intolerance assessment
Time frame: Signs of feeding intolerance will be assessed for seven days.
Absence of vomiting, diarrhea, constipation, abdominal distention, and Normal gastric residual volume.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jun 2023.
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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.
Sara EA Hegazy principal investigator
Faculty of Nursing, Mansoura University
Questions about this trial
What is this clinical trial studying?
A study testing enteral nutrition guidelines in people with Enteral Nutrition, run by Mansoura University.
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 3 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: status not confirmed, as of the sponsor's last update on 12 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Sara EA Hegazy, MSc (+201007106803, sarahegazy@mans.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Signs of feeding intolerance assessment (time frame: Signs of feeding intolerance will be assessed for seven days.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 12 Jun 2023.