NCT06156189

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
20

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Dec 2022

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 12, 2022

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 15, 2023

Completed
17 days until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2023

Completed
25 days until next milestone

First Submitted

Initial submission to the registry

November 26, 2023

Completed
9 days until next milestone

First Posted

Study publicly available on registry

December 5, 2023

Completed
Last Updated

December 5, 2023

Status Verified

November 1, 2023

Enrollment Period

10 months

First QC Date

November 26, 2023

Last Update Submit

November 26, 2023

Conditions

Critical Illness

Outcome Measures

Primary Outcomes (1)

  • Incidence of number of enteral feed interruptions

    Enteral feeding interruptions

    December 2022 to October 2023

Secondary Outcomes (4)

  • Calorie deficit

    December 2022 to October 2023

  • Reasons Delay in restarting Enteral feeding

    December 2022 to October 2023

  • Delay in feeding in hours

    December 2022 to October 2023

  • Avoidable and unavoidable delays

    December 2022 to October 2023

Study Arms (1)

Critically ill patients

All adult patients ventilated and intubated. These patients should also have enteral nutritional supplement initiated.

Dietary Supplement: Enteral Feeding

Interventions

Enteral FeedingDIETARY_SUPPLEMENT

Feeding via Nasogastric tube in intubated and ventilated patients

Critically ill patients

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

King Faisal Specialist Hospital and Research Centre

Al Madīnah, 42523, Saudi Arabia

Location

Related Publications (4)

  • Nurkkala JP, Kaakinen TI, Vakkala MA, Ala-Kokko TI, Liisanantti JH. Nutrition deficit during intensive care stay: incidence, predisposing factors and outcomes. Minerva Anestesiol. 2020 May;86(5):527-536. doi: 10.23736/S0375-9393.20.14068-9. Epub 2020 Jan 28.

    PMID: 32000472RESULT

  • Uozumi M, Sanui M, Komuro T, Iizuka Y, Kamio T, Koyama H, Mouri H, Masuyama T, Ono K, Lefor AK. Interruption of enteral nutrition in the intensive care unit: a single-center survey. J Intensive Care. 2017 Aug 4;5:52. doi: 10.1186/s40560-017-0245-9. eCollection 2017.

    PMID: 28794882RESULT

  • McClave SA, Sexton LK, Spain DA, Adams JL, Owens NA, Sullins MB, Blandford BS, Snider HL. Enteral tube feeding in the intensive care unit: factors impeding adequate delivery. Crit Care Med. 1999 Jul;27(7):1252-6. doi: 10.1097/00003246-199907000-00003.

    PMID: 10446815RESULT

  • Passier RH, Davies AR, Ridley E, McClure J, Murphy D, Scheinkestel CD. Periprocedural cessation of nutrition in the intensive care unit: opportunities for improvement. Intensive Care Med. 2013 Jul;39(7):1221-6. doi: 10.1007/s00134-013-2934-8. Epub 2013 May 1.

    PMID: 23636828RESULT

MeSH Terms

Conditions

Critical Illness

Interventions

Enteral Nutrition

Condition Hierarchy (Ancestors)

Disease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Feeding MethodsTherapeuticsNutritional SupportNutrition Therapy

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Consultant Pulmonary Physician

Study Record Dates

First Submitted

November 26, 2023

First Posted

December 5, 2023

Study Start

December 12, 2022

Primary Completion

October 15, 2023

Study Completion

November 1, 2023

Last Updated

December 5, 2023

Record last verified: 2023-11

Data Sharing

IPD Sharing
Will not share

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

Locations

SA(1)