- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05900323
Enteral Nutrition Guidelines and Patients' Outcomes
Effect of Implementing Enteral Nutrition Guidelines on Critical Care Nurses' Practice and Patients' Outcomes
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Sara EA Hegazy, MSc
- Phone Number: +201007106803
- Email: sarahegazy@mans.edu.eg
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Adult patients ≥ 18 years old.
- Hemodynamically stable patients.
- Patients who are unable to maintain volitional oral intake within 24 hours of admission.
Exclusion Criteria:
- 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).
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Enteral Nutrition Guidelines Group
It will include 34 patients who will receive enteral nutrition guidelines.
|
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.
Other Names:
|
No Intervention: Routine Enteral Nutrition Unit Care Group
It will include 34 patients who will receive routine enteral nutrition unit care.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
Signs of feeding intolerance will be assessed for seven days.
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Sara EA Hegazy, Faculty of Nursing, Mansoura University
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- Enteral Nutrition
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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