NCT05900323

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
68

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Sep 2023

Shorter than P25 for not_applicable

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 29, 2023

Completed
14 days until next milestone

First Posted

Study publicly available on registry

June 12, 2023

Completed
3 months until next milestone

Study Start

First participant enrolled

September 1, 2023

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 30, 2024

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2024

Completed
Last Updated

June 12, 2023

Status Verified

June 1, 2023

Enrollment Period

5 months

First QC Date

May 29, 2023

Last Update Submit

June 8, 2023

Conditions

Keywords

Enteral nutrition guidelinesCritical care nurses' practicePatients' outcomes

Outcome Measures

Primary Outcomes (1)

  • 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.

Study Arms (2)

Enteral Nutrition Guidelines Group

EXPERIMENTAL

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

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.

Interventions

enteral nutrition guidelinesCOMBINATION_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.

Also known as: prokinetic agent
Enteral Nutrition Guidelines Group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Adult patients ≥ 18 years old.
  • Hemodynamically stable patients.
  • Patients who are unable to maintain volitional oral intake within 24 hours of admission.

You may not qualify if:

  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Officials

  • Sara EA Hegazy

    Faculty of Nursing, Mansoura University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Sara EA Hegazy, MSc

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Lecturer

Study Record Dates

First Submitted

May 29, 2023

First Posted

June 12, 2023

Study Start

September 1, 2023

Primary Completion

January 30, 2024

Study Completion

June 30, 2024

Last Updated

June 12, 2023

Record last verified: 2023-06