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CompletedNCT03685435Updated Nov 21, 2019

Preoperative Presence of Gastric Content in Non-fasting Patients - an Ultrasound Study

An observational study in Non-fasting Patients, Rapid Sequence Intubation and Anesthesia Intubation Complication, sponsored by University Hospital, Akershus. Completed at 1 site in Norway. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-11-21.

Sponsored by University Hospital, Akershus · Observational

Study type
Observational
Model
Case-only
Time perspective
Prospective
Enrollment
72
Ages
18 Years and older
Sex
All
01

Study summary

Using bedside ultrasound, the investigators will examine gastric content in non-fasting patients assigned to rapid sequence intubation (RSI). The procedure will be done immediately before intubation. The percentage of non-fasting patients who actually have gastric content will be determined.

Identifying gastric content is critical because presence increases the risk of pulmonary aspiration during intubation.

Read the detailed description

Quantitative gastric content will be registered by measuring the cross section area of antrum using bedside ultrasound. The area and the patients age will be applied to estimate gastric volume.

02

Conditions studied

  • Non-fasting Patients
  • Rapid Sequence Intubation
  • Anesthesia Intubation Complication

Keywords

  • Ultrasound
  • Gastric content
  • Non-fasting
  • Rapid Sequence Induction
  • Gastric volume
03

In context

Lead sponsor

University Hospital, Akershus is the lead sponsor of 123 studies on the registry; 28 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

Patients that are assigned to rapid sequence intubation are considered non-fasting. Reasons for considering a patient non-fasting are among others: intake of food the last six hours, nausea, anxiety, preoperative intake of painkillers or reflux disease.

The ultrasound method we are using, are only valid for this specific population.

Inclusion criteria

  • adults scheduled for surgery
  • Adults over 18 years old that are assigned to general anesthesia with rapid sequence intubation (RSI)

Exclusion criteria

Exclusion Criteria:

  • Body mass index over 40
  • Pregnant women
  • Patients earlier underwent gastric surgery
  • Critically ill patients where spending time on ultrasound would cause a major disadvantage for the patients
05

Study design

Observational model
Case-only
Time perspective
Prospective
Enrollment
72 participants (actual)
Patient registry
No

Groups and cohorts

  • Non-fasting patients

    We will examine non-fasting patients using bedside ultrasound. First we examine the gaster in a supine position. Then we repeat the procedure in a right lateral position.

    Other: Bedside ultrasound

Interventions

  • OtherBedside ultrasound

    Checking for gastric content using bedside ultrasound

06

What researchers measure

Primary outcomes

  1. High risk of aspiration

    Detection of solids, or more than 1,5 mL/kg clear fluid in the gaster

    Time frame: Immediately before intubation

  2. Low risk of aspiration

    Detection of empty stomach, or less than 1,5 mL/kg clear fluid in the gaster

    Time frame: Immediately before intubation

07

Study locations

1 site
  • Akershus University Hospital
    Lørenskog, Akershus 1478, Norway
08

References and documents

Individual participant data

Plan to share: No — We have not planned to share data with other researchers.

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 21, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03685435
Lead sponsor
University Hospital, Akershus
Responsible party
Vegard Dahl (Professor 2, University Hospital, Akershus) — Principal investigator
First posted
Sep 26, 2018
Start date
Jan 2, 2019
Primary completion
Feb 17, 2019
Completion
Feb 17, 2019
Last update
Nov 21, 2019

Study contacts

Vegard Dahl, PhD
principal investigator · University Hospital, Akershus

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Nov 2019. You cannot join it, but the record below documents what was studied.

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