Clinical Trials Logo

Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT05900323
Other study ID # Enteral Nutrition
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date September 1, 2023
Est. completion date June 30, 2024

Study information

Verified date June 2023
Source Mansoura University
Contact Sara EA Hegazy, MSc
Phone +201007106803
Email sarahegazy@mans.edu.eg
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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. 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.


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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 68
Est. completion date June 30, 2024
Est. primary completion date January 30, 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Combination Product:
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.

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Mansoura University

Outcome

Type Measure Description Time frame Safety issue
Primary Signs of feeding intolerance assessment Absence of vomiting, diarrhea, constipation, abdominal distention, and Normal gastric residual volume. Signs of feeding intolerance will be assessed for seven days.
See also
  Status Clinical Trial Phase
Completed NCT02913677 - Prolonged Minimal Enteral Nutrition Versus Slowly Advancing Enteral Nutrition in Very Low Birth Weight Infants: N/A
Not yet recruiting NCT00916591 - Prokinetic Drugs and Enteral Nutrition N/A
Completed NCT01025167 - The Effect of a New Specific Enteral Formula Compared to a Standard Formula on the Tolerability of a Combined Radio- and Chemotherapy in Cancer Patients N/A
Completed NCT03153397 - Effect of Prebiotic Fiber- Enriched (scFOS) Enteral Feeding on the Microbiome in Neurological Injury Trauma Patients (PreFEED Microbiome Trial) N/A
Completed NCT02353689 - The Effect of FODMAP Content in Tube Feeding Formula on Feeding Intolerance and Nutritional Status Improvement Phase 2/Phase 3
Terminated NCT00564655 - Regional Anesthesia Block of the Transversus Abdominis Plane in Children Undergoing Gastric Tube Insertion Phase 3
Completed NCT06134674 - Early Versus Delayed Enteral Nutrition in Critically Ill Adults With COVID-19
Recruiting NCT03791866 - The Th9/IL-9 and Early Enteral Nutrition in Sepsis N/A
Enrolling by invitation NCT06161350 - The Multi-disciplinary Approach of Children With Feeding Difficulties and Tube Feeding in UZB Between 2000 and 2021
Active, not recruiting NCT02724631 - TubeClear® Evaluation in Pediatric Patients (Phase I) N/A
Completed NCT01988792 - Human Milk Fortification in Very Low Birth Neonates N/A
Completed NCT00600678 - Gastric Emptying Study After Administration of a High Caloric Sip Feed N/A
Completed NCT02998931 - Trial of Enteral Glutamine on Clinical Outcomes in Critically Ill Patients Phase 3
Not yet recruiting NCT06411873 - The Effect of High Protein Enteral Nutrition on Critically Ill Postoperative Children N/A
Recruiting NCT03176875 - Comparison of Partial and Exclusive Enteral Nutrition in the Treatment of Active Childhood-onset Crohn's Disease N/A
Completed NCT02779335 - Enteral Formula Tolerance in Pediatric Patients N/A
Completed NCT05411848 - 2kcal Tube Feed Study N/A
Completed NCT04868318 - The Impact of Intervention With High-protein Enteral Formula in SICU. N/A
Withdrawn NCT04601571 - Confirming Feeding Tube Position Using CORTRAK N/A
Not yet recruiting NCT06239610 - DrIFT 2 Study: Displacement in Feeding Tubes N/A