Preparative Fasting Before Contrast-enhanced Computed Tomography

X-ray Contrast Media Adverse Reaction Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03533348
• Other study ID #: 0167-17-EMC
• Status: Completed
• Start date: July 31, 2018
• Est. completion date: October 10, 2019

Study information

• Verified date: October 2019
• Source: HaEmek Medical Center, Israel
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2148
• Est. completion date: October 10, 2019
• Est. primary completion date: October 10, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• X-ray Contrast Media Adverse Reaction

Locations

Country	Name	City	State
Israel	Emek Medical Center	Afula

Sponsors (1)

Lead Sponsor	Collaborator
HaEmek Medical Center, Israel

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Aspiration pneumonitis	Rates of aspiration pneumonitis after contrast-enhanced CT scans	Day 1
Secondary	Gastrointestinal symptoms	Rates of nausea and vomiting after contrast-enhanced CT scans	Hour 1