Preparative Fasting Before Contrast-enhanced Computed Tomography

Completed

• Conditions: X-ray Contrast Media Adverse Reaction

• Registration Number: NCT03533348
• Lead Sponsor: HaEmek Medical Center, Israel

Brief Summary

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

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 Timeline

• Study First Submitted: 2018-04-30
• Study First Submitted QC: 2018-05-10
• Study First Posted: 2018-05-23
• Study Start: 2018-07-31
• Status Verified: 2019-10
• Primary Completion: 2019-10-10
• Study Completion: 2019-10-10
• Last Update Submitted: 2019-10-21
• Last Update Posted: 2019-10-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 2148

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Aspiration pneumonitis	Day 1	Rates of aspiration pneumonitis after contrast-enhanced CT scans

Secondary Outcome Measures

Name	Time	Method
Gastrointestinal symptoms	Hour 1	Rates of nausea and vomiting after contrast-enhanced CT scans

Trial Locations

Locations (1)

Emek Medical Center; 🇮🇱 Afula, Israel