Enteral Nutrition Guidelines and Patients' Outcomes

NCT ID: NCT05900323

Last Updated: 2023-06-12

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 68 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-09-01
• Study Completion Date: 2024-06-30

Brief 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.

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Enteral Nutrition Guidelines Group

It will include 34 patients who will receive enteral nutrition guidelines.

Group Type: EXPERIMENTAL

enteral nutrition guidelines

Intervention Type: COMBINATION_PRODUCT

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.

Routine Enteral Nutrition Unit Care Group

It will include 34 patients who will receive routine enteral nutrition unit care.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: COMBINATION_PRODUCT

Other Intervention Names

prokinetic agent

Eligibility Criteria

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).

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Mansoura University

OTHER

Sponsor Role: lead

Responsible Party

sara Elsayed Ali Hegazy

Assistant Lecturer

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Sara EA Hegazy

Role: PRINCIPAL_INVESTIGATOR

Faculty of Nursing, Mansoura University

Central Contacts

Sara EA Hegazy, MSc

Role: CONTACT

sarahegazy@mans.edu.eg

+201007106803

Other Identifiers

Enteral Nutrition

Identifier Type: -

Identifier Source: org_study_id