UndefinedNCT06216912
Gastric Volume in Paralyzed Obese Patients After High-flow Nasal Oxygen Therapy
An observational study of Undefined, run by Seoul National University Hospital at 1 site in South Korea.
Trial summary
Preoperative preoxygenation is performed using High-flow nasal oxygen therapy, and the gastric volume before and after High-flow nasal oxygen therapy is measured by ultrasound and compared in obese patients undergoing surgery under general anesthesia. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Undefined
- How many people
- 60 participants
- Where
- 1 siteSouth Korea
- Study dates
- 10 Jan 2024to 31 Jan 2025
- 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 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Obese patients undergoing surgery under general anesthesia
Who may be able to join
- Adult patients with a BMI of 30 kg/m2 or more, undergoing surgery under general anesthesia
Who cannot join
- Nasotracheal intubation
- History of a surgery or anatomical anomaly in the head and neck
- History of Inability to breathe through nose
- History of difficult airway
- Severe cardiac or respiratory disease
- Gastric reflux disease, diabetes, pregnancy
- Previous gastric surgery
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
SMG - SNU Boramae Medical Center
Seoul, 07061
Tae Kyong Kim, MD, 82-2-2072-2467, ktkktk@gmail.com
About this study
Official title: Ultrasound Assessment of Gastric Volume in Paralyzed Obese Patients After High-flow Nasal Oxygen Therapy
Preoperative preoxygenation is performed using High-flow nasal oxygen therapy, and the gastric volume before and after High-flow nasal oxygen therapy is measured by ultrasound and compared in obese patients undergoing surgery under general anesthesia.
Read the detailed description
Preoperative preoxygenation is performed using High-flow nasal oxygen therapy, and the gastric volume before and after High-flow nasal oxygen therapy is measured by ultrasound and compared in obese patients undergoing surgery under general anesthesia.
- Conditions
- Undefined
What is being measured
The primary outcome is the main question the study is designed to answer.
gastric volume measured by gastric ultrasound
gastric volume measured by gastric ultrasound
Measured: immediately before HFNOT, immediately after HFNOT, immediately after tracheal intubation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jan 2024
- Study start10 Jan 2024
- Primary completion1 Jan 2025 (estimated)
- Study completion31 Jan 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for UndefinedStudies of the same condition, open and under way.
- More trials run by Seoul National University HospitalThe sponsor's other registered studies.
- 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
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- SMG-SNU Boramae Medical Center
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06216912
- Sponsor's protocol ID
- HFNOT_gastric
- Status last verified
- Jan 2024
- First submitted
- 3 Jan 2024
- Last updated
- 30 May 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ultrasound Assessment of Gastric Volume in Paralyzed Obese Patients After High-flow Nasal Oxygen Therapy
- ClinicalTrials.gov ID
- NCT06216912
- Acronym / sponsor ID
- HFNOT_gastric
- Conditions
- Undefined
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Collaborators
- SMG-SNU Boramae Medical Center
- Study start
- 10 Jan 2024 (actual)
- Primary completion
- 1 Jan 2025 (estimated)
- Study completion
- 31 Jan 2025 (estimated)
- First posted
- 22 Jan 2024 (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.
Preoperative preoxygenation is performed using High-flow nasal oxygen therapy, and the gastric volume before and after High-flow nasal oxygen therapy is measured by ultrasound and compared in obese patients undergoing surgery under general anesthesia.
Detailed description
Preoperative preoxygenation is performed using High-flow nasal oxygen therapy, and the gastric volume before and after High-flow nasal oxygen therapy is measured by ultrasound and compared in obese patients undergoing surgery under general anesthesia.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Obese patients undergoing surgery under general anesthesia
Key inclusion criteria (1 listed)
- Adult patients with a BMI of 30 kg/m2 or more, undergoing surgery under general anesthesia
Key exclusion criteria (7 listed)
- Nasotracheal intubation
- History of a surgery or anatomical anomaly in the head and neck
- History of Inability to breathe through nose
- History of difficult airway
- Severe cardiac or respiratory disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
gastric volume measured by gastric ultrasound
Time frame: immediately before HFNOT, immediately after HFNOT, immediately after tracheal intubation
gastric volume measured by gastric ultrasound
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 May 2024.
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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.
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 Undefined, run by Seoul National University Hospital at 1 site in South Korea.
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 1 inclusion and 7 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: status not confirmed, as of the sponsor's last update on 30 May 2024. 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 South Korea. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Tae Kyong Kim (82-2-870-2519, ktkktk@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
gastric volume measured by gastric ultrasound (time frame: immediately before HFNOT, immediately after HFNOT, immediately after tracheal intubation). 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 30 May 2024.