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

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ClinicalTrials.gov Identifier: NCT03685435
Recruitment Status : Recruiting
First Posted : September 26, 2018
Last Update Posted : January 7, 2019
Sponsor:
Information provided by (Responsible Party):
Vegard Dahl, University Hospital, Akershus

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.


Condition or disease Intervention/treatment
Non-fasting Patients Rapid Sequence Intubation Anesthesia Intubation Complication Other: Bedside ultrasound

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.

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Study Type : Observational
Estimated Enrollment : 100 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Preoperative Presence of Gastric Content in Non-fasting Patients - an Ultrasound Study
Actual Study Start Date : January 2, 2019
Estimated Primary Completion Date : July 15, 2019
Estimated Study Completion Date : July 15, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Ultrasound

Group/Cohort Intervention/treatment
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
Checking for gastric content using bedside ultrasound




Primary Outcome Measures :
  1. High risk of aspiration [ Time Frame: Immediately before intubation ]
    Detection of solids, or more than 1,5 mL/kg clear fluid in the gaster

  2. Low risk of aspiration [ Time Frame: Immediately before intubation ]
    Detection of empty stomach, or less than 1,5 mL/kg clear fluid in the gaster



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   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.

Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03685435


Contacts
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Contact: Vegard Dahl, PhD 47-91674604 vegard.dahl@ahus.no
Contact: Felix Haidl, Cand.med 47-46656707 felix.haidl@ahus.no

Locations
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Norway
Akershus University Hospital Recruiting
Lørenskog, Akershus, Norway, 1478
Contact: Vegard Dahl, dr.med    47-91674604    vegard.dahl@ahus.no   
Contact: Felix Haidl, Cand.med    47-46656707    felix.haidl@ahus.no   
Sub-Investigator: Linn R Johnsen, Stud.med         
Sub-Investigator: Ingvild Holtan-Hartwig, Stud.med         
Principal Investigator: Vegard Dahl, dr.med         
Sponsors and Collaborators
University Hospital, Akershus
Investigators
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Principal Investigator: Vegard Dahl, PhD University Hospital, Akershus

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Responsible Party: Vegard Dahl, Professor 2, University Hospital, Akershus
ClinicalTrials.gov Identifier: NCT03685435     History of Changes
Other Study ID Numbers: 2018/1560
First Posted: September 26, 2018    Key Record Dates
Last Update Posted: January 7, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: We have not planned to share data with other researchers.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Vegard Dahl, University Hospital, Akershus:
Ultrasound
Gastric content
Non-fasting
Rapid Sequence Induction
Gastric volume