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

NCT03685435 | Completed

• 1 other identifier: 2018/1560
• Study Type: observational
• Target: 72
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

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

Keywords

Ultrasound; Gastric content; Non-fasting; Rapid Sequence Induction; Gastric volume

Outcome Measures

Primary Outcomes (2)

• High risk of aspiration

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

  Immediately before intubation

• Low risk of aspiration

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

  Immediately before intubation

Study Arms (1)

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

Bedside ultrasound OTHER

Checking for gastric content using bedside ultrasound

Non-fasting patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Akershus: lead

Study Sites (1)

Akershus University Hospital

Lørenskog, Akershus, 1478, Norway

Location

Study Officials

• Vegard Dahl, PhD

  University Hospital, Akershus

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor 2

Study Record Dates

• First Submitted: September 25, 2018
• First Posted: September 26, 2018
• Study Start: January 2, 2019
• Primary Completion: February 17, 2019
• Study Completion: February 17, 2019
• Last Updated: November 21, 2019

Record last verified: 2019-11

Data Sharing

• IPD Sharing: Will not share

Locations

NO (1)