Gastric DistentionNCT04629911
High Flow Nasal Oxygenation and Gastric Insufflation in Anesthetized Patients
A study testing THRIVE in people with Gastric Distention, run by Ajou University School of Medicine at 1 site in South Korea.
Trial summary
Transnasal humidified rapid-insufflation ventilatory exchange(THRIVE), or also termed high flow nasal oxygenation (HFNO) is a method of supplying heated, humidified high concentrations of oxygen via nasal cavity. Read more about this study
- Who is it for?
- Ages 19 to 80 years
- Conditions the study is for
- Gastric Distention
- What is being tested?
- THRIVE
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteSouth Korea
- Study dates
- 23 Nov 2020to 24 Aug 2021
- Phase
- Interventional
- 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 19 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- American Society of Anesthesiology physical status classification I and II
- Patients scheduled for laryngeal microsurgery under general anesthesia
Who cannot join
- gastroesophageal reflux
- gastric pathology
- pregnancy
- major cardiovascular, pulmonary, or cerebrovascular disease
- severe obesity (body mass index>35 kg/m2)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of High Flow Nasal Oxygenation on Gastric Insufflation in Paralyzed Anesthetized Patients Undergoing Laryngologic Surgery
Transnasal humidified rapid-insufflation ventilatory exchange(THRIVE), or also termed high flow nasal oxygenation (HFNO) is a method of supplying heated, humidified high concentrations of oxygen via nasal cavity.
The purpose of this study is to investigate the effect of HFNO on gastric insufflation in paralyzed anesthetized patients undergoing laryngologic surgery.
Read the detailed description
HFNO can be used during intraoperative period. HFNO reduces the risk of desaturation and prolongs the safe apnea time, compared with conventional oxygenation.
In laryngeal microsurgery, HFNO therapy make possible to perform tubeless anesthesia, providing perfect exposure of structure of the vocal cords.
HFNO have a risk for low level of positive pressure can make gastric distension, but gastric reflux or aspiration were not occurred during rapid sequence induction for emergency operation.
The purpose of this study is to investigate the effect of HFNO on gastric insufflation in paralyzed anesthetized patients undergoing laryngologic surgery.
- Conditions
- Gastric Distention
- Being tested
- THRIVE
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
THRIVEDevice
Also called Optiflow
Patients will receive HFNO therapy during laryngomicrosurgery. Patients will undergo a gastric ultrasound examination after HFNO therapy.
| Study group | Role | What they receive |
|---|---|---|
| HFNO arm | Experimental | Patients will receive HFNO therapy during laryngomicrosurgery. Receives: Device: THRIVE |
What is being measured
The primary outcome is the main question the study is designed to answer.
change of gastric volume
Ultrasound exam will measure the antral cross-sectional area of gastric antrum
Measured: before HFNO application (baseline), immediately after HFNO application
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Nov 2020
- Study start23 Nov 2020
- Primary completion24 Aug 2021
- Study completion24 Aug 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastric DistentionStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ajou University School of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jong Yeop Kim, Ajou University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04629911
- Sponsor's protocol ID
- MED-DE1-20-424
- Status last verified
- Jan 2022
- First submitted
- 10 Nov 2020
- Last updated
- 5 Jan 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of High Flow Nasal Oxygenation on Gastric Insufflation in Paralyzed Anesthetized Patients Undergoing Laryngologic Surgery
- ClinicalTrials.gov ID
- NCT04629911
- Acronym / sponsor ID
- MED-DE1-20-424
- Conditions
- Gastric Distention
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- Ajou University School of MedicineUniversity, hospital or other
- Study start
- 23 Nov 2020 (actual)
- Primary completion
- 24 Aug 2021 (actual)
- Study completion
- 24 Aug 2021 (actual)
- First posted
- 16 Nov 2020 (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.
Transnasal humidified rapid-insufflation ventilatory exchange(THRIVE), or also termed high flow nasal oxygenation (HFNO) is a method of supplying heated, humidified high concentrations of oxygen via nasal cavity.
The purpose of this study is to investigate the effect of HFNO on gastric insufflation in paralyzed anesthetized patients undergoing laryngologic surgery.
Detailed description
HFNO can be used during intraoperative period. HFNO reduces the risk of desaturation and prolongs the safe apnea time, compared with conventional oxygenation.
In laryngeal microsurgery, HFNO therapy make possible to perform tubeless anesthesia, providing perfect exposure of structure of the vocal cords.
HFNO have a risk for low level of positive pressure can make gastric distension, but gastric reflux or aspiration were not occurred during rapid sequence induction for emergency operation.
The purpose of this study is to investigate the effect of HFNO on gastric insufflation in paralyzed anesthetized patients undergoing laryngologic surgery.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| HFNO arm | Experimental | Device: THRIVEPatients will receive HFNO therapy during laryngomicrosurgery. |
Who may qualify
- Ages
- 19 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- American Society of Anesthesiology physical status classification I and II
- Patients scheduled for laryngeal microsurgery under general anesthesia
Key exclusion criteria (5 listed)
- gastroesophageal reflux
- gastric pathology
- pregnancy
- major cardiovascular, pulmonary, or cerebrovascular disease
- severe obesity (body mass index>35 kg/m2)
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 |
|---|---|---|
| THRIVEAlso: OptiflowPatients will receive HFNO therapy during laryngomicrosurgery. Patients will undergo a gastric ultrasound examination after HFNO therapy. | Device | HFNO arm |
Primary outcome
change of gastric volume
Time frame: before HFNO application (baseline), immediately after HFNO application
Ultrasound exam will measure the antral cross-sectional area of gastric antrum
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 5 Jan 2022.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing THRIVE in people with Gastric Distention, run by Ajou University School of Medicine 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 2 inclusion and 5 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 5 Jan 2022. 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?
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?
change of gastric volume (time frame: before HFNO application (baseline), immediately after HFNO application). 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 5 Jan 2022.