Prevalence of Enteral Nutrition Interruption in an Oncology Intensive Care Unit.

November 26, 2023 updated by: Muhammad Rehan Akram, King Faisal Specialist Hospital and Research Centre Madinah

Prevalence of Enteral Nutrition Interruption in an Oncology Intensive Care Unit. A Prospective Observational Study

This is a single-center retrospective observational study. The study aimed to look at the enteral feed interruptions in patients who were intubated and ventilated in an oncology intensive care unit. We collected data of the first 60 interruptions in the adult Oncology ICU from 12/12/2022 to 15/10/2023. We only included intubated and ventilated adult patients more than 18 years of age who had nasogastric tube feeding commenced. The data was collected from the electronic patient records. Data collected included demographics, total interruption time per episode of interruption, the reason for the delay, whether the delay could have been avoided, total calories lost, and percentage of calories lost.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Introduction Intensive Care Unit (ICU) patients are often intubated and ventilated. These patients cannot feed themselves orally, so enteral or parenteral nutrition becomes important. Various studies have suggested that meeting their nutritional demand is associated with their short and long-term outcomes. There is also ample evidence that in general ICU's, patients often do not meet their nutritional demands. (1,2) The ICU may often differ in the nature of the patients catered for and also may have very different systems of delivering healthcare provisions. This could have an impact on the patient care provided.

There are several studies suggesting that EN interruptions happen frequently in the ICU. (3,4,5) It is estimated that the EN interruption occurs in more than 85% of the patients for an average of 8-20% of the infusion time. Out of this, it is thought that 23% are avoidable in planned procedures and 65% on all occasions. (6) There is very little data on the duration of the interruptions and those associated with diagnostic procedures.

In this single-centre study, we aim to understand the prevalence of instances of missed feeding within an oncology-focused ICU in intubated patients. We looked at the reason for the delay and estimated the calorie deficit, the duration of the delay and the proportion of patients who met at least 60% of the calorie requirement. This is an important step in developing a feeding protocol to minimize such instances.

Methods This study included all intubated patients admitted to the Intensive Care Unit at the King Faisal Specialist Hospital and Research Centre from December 2022 to November 2023. The inclusion criteria were defined as adult patients above the age of 18 who were intubated and ventilated and started on enteral feeding via nasogastric tube. All patients who were not intubated and under 18 years of age were excluded.

Data will be collected from the electronic patient records. The data collected will be demographics, diagnosis, time the feed was started and stopped, delay in restarting the feed, estimated daily calorie requirement, and calorie deficit. The daily calorie requirement will be estimated using the quick calorie method using kilocalories per kilogram Table1. To estimate the actual calorie intake of the patient, the enteral feeding flowsheet of each patient was monitored, and the total intake will be calculated (mL/hr) for the whole day and based on the type of feed (High calorie, standard etc) it will be multiplied to the total intake to get the actual calorie intake.

Energy requirements Based on Kilocalories per kilogram of body weight condition Energy requirement (kcal/kg) Normal 25-30 (kcal/kg) Obese, critically ill, (BMI>30) 11-14 (actual body weight) or 22-25 (ideal body weight) Mild stress 30-35 (kcal/kg) Moderate to severe 35-45 (kcal/kg)

Table1. The formula used for estimating calorie requirement. The calorie deficit was calculated from this. The percentage of lost calories will be tabulated, and the number of instances where patients received >60% or <60% of the daily requirement will be computed.

The local Research Ethics Committee approved the study. As the study was a non-interventional observational study, a consent waiver was requested and was approved by the ethics committee.

Statistical analysis Demographics will be analyzed for the frequency of distribution. The incidence of feed interruption will be calculated and expressed as median, mean and percentage. The proportion of lost calories and calorie deficit will be calculated in numbers and percentages. The commonest reason for delay, avoidable and unavoidable reasons for feed interruption and the proportion of patients who missed more than 60% of the estimated daily requirement will be estimated using frequencies. Spearmen's correlation rank test will be used to examine the relation between the delay in restarting feed and the lost calories.

Study Type

Observational

Enrollment (Actual)

20

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Al Madīnah, Saudi Arabia, 42523
        • King Faisal Specialist Hospital and Research Centre

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

-All adult patients who were intubated and ventilated in an adult oncology ICU

Description

Inclusion Criteria:

- Adult patients above the age of 18 who were intubated and ventilated and started on enteral feeding via nasogastric tube

Exclusion Criteria:

  • Patients less than the age of 18
  • Patients not intubated and ventilated
  • Patients not critically ill

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Critically ill patients
All adult patients ventilated and intubated. These patients should also have enteral nutritional supplement initiated.
Feeding via Nasogastric tube in intubated and ventilated patients

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of number of enteral feed interruptions
Time Frame: December 2022 to October 2023
Enteral feeding interruptions
December 2022 to October 2023

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Calorie deficit
Time Frame: December 2022 to October 2023
Estimated daily calorie required was calculated and actual calorie received by the patient was calculated and calorie deficit was calculated from this.
December 2022 to October 2023
Reasons Delay in restarting Enteral feeding
Time Frame: December 2022 to October 2023
Reasons for stopping and restarting feed was recorded
December 2022 to October 2023
Delay in feeding in hours
Time Frame: December 2022 to October 2023
Delay in restarting the feed in hours were calculated
December 2022 to October 2023
Avoidable and unavoidable delays
Time Frame: December 2022 to October 2023
If the delays were due to factors that could be modified or not modifiable were recorded
December 2022 to October 2023

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 12, 2022

Primary Completion (Actual)

October 15, 2023

Study Completion (Actual)

November 1, 2023

Study Registration Dates

First Submitted

November 26, 2023

First Submitted That Met QC Criteria

November 26, 2023

First Posted (Estimated)

December 5, 2023

Study Record Updates

Last Update Posted (Estimated)

December 5, 2023

Last Update Submitted That Met QC Criteria

November 26, 2023

Last Verified

November 1, 2023

More Information

Terms related to this study

Other Study ID Numbers

  • REC-2022- 0005

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

As of now there is no ethical approval and reason to share individual patient details. However, the team will be able to share anonymized dataset if deemed necessary

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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