Preparative Fasting Before Contrast-enhanced Computed Tomography

October 21, 2019 updated by: Naiel Bisharat, HaEmek Medical Center, Israel

Preparative Fasting for Contrast-enhanced Computed tomography-a Prospective Randomized Study

The study aims to determine whether there is a need for preparative fasting prior to contrast-enhanced computed tomography (CT).

Study Overview

Status

Completed

Conditions

Detailed Description

The use of fasting orders for imaging and other procedures is common, this seemingly benign practice can lead to real harms to patients and poor satisfaction with their care. The nothing per os (NPO) order is sometimes used in CT scans because gastrointestinal tract contents can interrupt visualization of the intestinal lumen, but more commonly NPO orders are are thought to protect all supine patients from aspiration during delivery of intravenous contrast. There is limited evidence to support such practice of NPO orders prior to contrast-enhanced CT scans. The authors' main objective is to determine if there is a need for preparative fasting prior to contrast-enhanced CT scans.

Study Type

Observational

Enrollment (Actual)

2148

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

  • Israel
      • Afula, Israel, 18341
        • Emek Medical Center

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

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

The participants are inpatients who are undergoing contrast enhanced computed tomography that will be divided into two cohorts. The first will need at least 4 hours of fasting prior to contrast enhanced computed tomography scans and the second will be allowed to eat and drink freely prior to contrast enhanced computed tomography scans

Description

Inclusion Criteria:

- Patients undergoing contrast-enhanced CT scans

Exclusion Criteria:

  1. Pateints undergoing CT scans while sedated.
  2. Patients under the age of 18 years

  3. Patients who suffer from a mental disorder that prevents them:

    1. from understanding what s/he consents to and/ or
    2. from choosing decisively and/ or
    3. from communicating his/her consent
  4. Patients who were instructed not to eat due to requirements of a specific study (for example.. computed tomography enterography-CTE)

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
Fasting arm
Patients will need at least 4 hours of fasting prior to contrast-enhanced CT scans.
No fasting
Patients are allowed to eat and drink freely prior to contrast-enhanced CT scans.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Aspiration pneumonitis
Time Frame: Day 1
Rates of aspiration pneumonitis after contrast-enhanced CT scans
Day 1

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Gastrointestinal symptoms
Time Frame: Hour 1
Rates of nausea and vomiting after contrast-enhanced CT scans
Hour 1

Collaborators and Investigators

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

Sponsor

HaEmek Medical Center, Israel

Investigators

  • Principal Investigator: Naiel Bisharat, MD, Emek Medical Center

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.

General Publications

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)

July 31, 2018

Primary Completion (Actual)

October 10, 2019

Study Completion (Actual)

October 10, 2019

Study Registration Dates

First Submitted

April 30, 2018

First Submitted That Met QC Criteria

May 10, 2018

First Posted (Actual)

May 23, 2018

Study Record Updates

Last Update Posted (Actual)

October 22, 2019

Last Update Submitted That Met QC Criteria

October 21, 2019

Last Verified

October 1, 2019

More Information

Terms related to this study

Other Study ID Numbers

  • 0167-17-EMC

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

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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