Non-fasting PatientsNCT03685435
Preoperative Presence of Gastric Content in Non-fasting Patients - an Ultrasound Study
An observational study of Non-fasting Patients and Rapid Sequence Intubation, run by University Hospital, Akershus at 1 site in Norway.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non-fasting Patients, Rapid Sequence Intubation, Anesthesia Intubation Complication
- What is being tested?
- Bedside ultrasound
- How many people
- 72 participants
- Where
- 1 siteNorway
- Study dates
- 2 Jan 2019to 17 Feb 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- adults scheduled for surgery
- Adults over 18 years old that are assigned to general anesthesia with rapid sequence intubation (RSI)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Being tested
- Bedside ultrasound
- Keywords
- Ultrasound, Gastric content, Non-fasting, Rapid Sequence Induction, Gastric volume
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bedside ultrasoundOther
Checking for gastric content using bedside ultrasound
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Bedside ultrasound |
What is being measured
The primary outcome is the main question the study is designed to answer.
High risk of aspiration
Detection of solids, or more than 1,5 mL/kg clear fluid in the gaster
Measured: Immediately before intubation
Low risk of aspiration
Detection of empty stomach, or less than 1,5 mL/kg clear fluid in the gaster
Measured: Immediately before intubation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Sep 2018
- Study start2 Jan 2019
- Primary completion17 Feb 2019
- Study completion17 Feb 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-fasting PatientsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 72 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Akershus
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Vegard Dahl, University Hospital, Akershus
- Investigators
- Vegard Dahl, PhD, Principal investigator, University Hospital, Akershus
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03685435
- Sponsor's protocol ID
- 2018/1560
- Status last verified
- Nov 2019
- First submitted
- 25 Sep 2018
- Last updated
- 21 Nov 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: We have not planned to share data with other researchers.
Study at a glance
From the registry record, last updated by the sponsor on 21 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Preoperative Presence of Gastric Content in Non-fasting Patients - an Ultrasound Study
- ClinicalTrials.gov ID
- NCT03685435
- Acronym / sponsor ID
- 2018/1560
- Keywords
- Ultrasound, Gastric content, Non-fasting, Rapid Sequence Induction, Gastric volume
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 72 participants (actual)
- Lead sponsor
- University Hospital, AkershusUniversity, hospital or other
- Study start
- 2 Jan 2019 (actual)
- Primary completion
- 17 Feb 2019 (actual)
- Study completion
- 17 Feb 2019 (actual)
- First posted
- 26 Sep 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Non-fasting patients | – | Other: Bedside ultrasoundWe 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (2 listed)
- adults scheduled for surgery
- Adults over 18 years old that are assigned to general anesthesia with rapid sequence intubation (RSI)
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Bedside ultrasoundChecking for gastric content using bedside ultrasound | Other | Non-fasting patients |
Primary outcome
High risk of aspiration
Time frame: Immediately before intubation
Detection of solids, or more than 1,5 mL/kg clear fluid in the gaster
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Nov 2019.
- Individual participant dataSharing planned: No. We have not planned to share data with other researchers.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Vegard Dahl, PhD principal investigator
University Hospital, Akershus
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Non-fasting Patients and Rapid Sequence Intubation, run by University Hospital, Akershus at 1 site in Norway.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Nov 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
High risk of aspiration (time frame: Immediately before intubation). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Nov 2019.