Ultrasound Vs. Free Drainage for Gastric Volume in ICU Patients on Enteral Nutrition

NCT06700759 | Completed

• 1 other identifier: 2011-KAEK-25 2022/01-19
• Study Type: observational
• Target: 78
• Locations: 1 country
• Sites: 1

Brief Summary

This study aims to evaluate the compatibility of gastric volume (GV) measurements obtained through ultrasound with the free drainage method in intensive care patients receiving enteral nutrition under three different protocols. The study seeks to determine the consistency of GV measurements across these protocols to improve patient management in critical care settings.

Conditions

Gastric Residual Volume

Keywords

ultrasonography; gastric residual volume; enteral feeding

Outcome Measures

Primary Outcomes (1)

• Agreement Between Ultrasound and Free Drainage for Gastric Volume Measurements

  Gastric volume will be measured in ICU patients using ultrasound imaging and the free drainage method. Agreement between the two methods will be evaluated using Bland-Altman analysis and Intraclass Correlation Coefficients (ICCs). The data will be reported as mean ± standard deviation for continuous variables and proportions for categorical data. Results will be aggregated across the three enteral nutrition protocols.

  Gastric volume measurements will be conducted at 24 hours after initiating each enteral nutrition protocol

Other Outcomes (1)

• complications

  Complications will be recorded at 24-hour intervals during the ICU stay, up to a maximum of 7 days.

Study Arms (3)

Group 1

Patients who received 18 hours of infusion feeding, 6 hours of waiting and one hour of drainage

Group 2

Patients who received 5 hours of infusion feeding, 1 hour of waiting and one hour of drainage

Group 3

Patients who were fed with continuous infusion for 24 hours and drained for one hour

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

neurocritical care patients

You may qualify if:

• Age Range: Adult patients aged 18 years and older.
• ICU Admission: The study will include only patients who are currently admitted to the Intensive Care Unit (ICU) due to cerebrovascular diseases
• Receiving Enteral Nutrition: Patients must be receiving enteral nutrition through one of the three specified protocols.
• Eligibility for Gastric Volume (GV) Measurement: Patients must be medically eligible for GV measurement via ultrasound.
• Informed Consent: The patient or their legal representative must provide informed consent to participate in the study.

You may not qualify if:

• Age Below 18: Patients under 18 years of age.
• Pregnancy: Pregnant patients will be excluded due to potential risks or confounding factors related to pregnancy.
• Gastrointestinal Surgery History: Patients with a recent history of gastrointestinal surgery, which may affect GV measurements, will be excluded.
• Contraindications for Ultrasound: Patients with conditions that prevent safe or accurate ultrasound measurement (e.g., severe abdominal wounds or high abdominal obesity) will be excluded.
• Inability to Tolerate Enteral Nutrition: Patients who are unable to receive enteral nutrition for any reason (e.g., severe intolerance, contraindications) will be excluded.
• Lack of Informed Consent: Patients or their legal representatives who do not provide informed consent.

Sponsors & Collaborators

• Ilkay Ceylan: lead

Study Sites (1)

Bursa Yüksek İhtisas Education and Research Hospital

Bursa, Turkey (Türkiye)

Location

Study Officials

• İlkay Ceylan

  Bursa Yüksek İhtisas Training Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: November 13, 2024
• First Posted: November 22, 2024
• Study Start: January 20, 2022
• Primary Completion: June 20, 2022
• Study Completion: July 1, 2022
• Last Updated: November 22, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will share
• Time Frame: Beginning 3 months and ending 3 years after the publication of results
• Access Criteria: Who Will Be Able to Access the Data: Access to the study data will be limited to authorized researchers affiliated with accredited academic or healthcare institutions who have a valid research purpose aligned with the study objectives. Regulatory authorities may also be granted access if required for compliance or validation purposes. What They Will Be Able to Access: De-identified individual participant data (IPD), including demographic data, primary and secondary outcome measures, and other relevant clinical data collected during the study. Supporting documentation, such as the study protocol, statistical analysis plan, and informed consent forms. How They Will Be Able to Access It: Data will be provided through a secure data-sharing platform or repository, with access granted upon approval by the study's data access committee. Interested researchers must submit a data access request that includes an agreement to maintain data confidentiality

Locations

TU (1)