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NCT03685435 Clinical Trial

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

Anesthesia Intubation Complication Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT03685435
Other study ID # 2018/1560
Secondary ID
Status Completed
Phase
First received
Last updated
Start date January 2, 2019
Est. completion date February 17, 2019

Study information
Verified date November 2019
Source University Hospital, Akershus
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Completed
Enrollment 72
Est. completion date February 17, 2019
Est. primary completion date February 17, 2019
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:

- adults scheduled for surgery

- Adults over 18 years old that are assigned to general anesthesia with rapid sequence intubation (RSI)

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

Study Design

Related Conditions & MeSH terms

Intervention

Other:
• Bedside ultrasound
Checking for gastric content using bedside ultrasound

Locations
Country Name City State
Norway Akershus University Hospital Lørenskog Akershus

Sponsors (1)
Lead Sponsor Collaborator
University Hospital, Akershus

Country where clinical trial is conducted

Norway, 

Outcome
Type Measure Description Time frame Safety issue
Primary High risk of aspiration Detection of solids, or more than 1,5 mL/kg clear fluid in the gaster Immediately before intubation
Primary Low risk of aspiration Detection of empty stomach, or less than 1,5 mL/kg clear fluid in the gaster Immediately before intubation
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