LaryngoscopyNCT03241979
THRIVE in Pediatric Laryngeal Microsurgery
An observational study of Laryngoscopy, run by Seoul National University Hospital at 1 site in South Korea.
Trial summary
Transnasal High-flow rapid-insufflation ventilatory exchange (THRIVE) has been shown to benefit oxygenation, ventilation and upper airway patency in a range of clinical scenarios, however its use in spontaneously breathing pediatric patients undergoing tubeless airway surgery has not been described. Read more about this study
- Who is it for?
- Ages Up to 6 years
- Conditions the study is for
- Laryngoscopy
- How many people
- 30 participants
- Where
- 1 siteSouth Korea
- Study dates
- 7 Aug 2017to 3 Jun 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 Up to 6 years
- All sexes
- No healthy volunteers
- Child
Study population: pediatric patients
Who may be able to join
- pediatric patients undergoing laryngeal microsurgery with spontaneous ventilation
Who cannot join
- Severe gastrointestinal reflux disease Neuromuscular disease Central hypoventilation
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effects of Transnasal Humidified Rapid Insufflation Ventilator Exchange (THRIVE) on the Oxygenation in Pediatric Patients Under Tubeless Airway Surgery - a Physiologic Study
Transnasal High-flow rapid-insufflation ventilatory exchange (THRIVE) has been shown to benefit oxygenation, ventilation and upper airway patency in a range of clinical scenarios, however its use in spontaneously breathing pediatric patients undergoing tubeless airway surgery has not been described. This is a physiologic study that evaluates the feasibility of THRIVE during pediatric airway surgery under self-respiration.
- Conditions
- Laryngoscopy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| laryngeal microsurgery | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
number of low saturation events
oxygen saturation decrease lower than 90%
Measured: Intraoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Aug 2017
- Study start7 Aug 2017
- Primary completion3 Jun 2019
- Study completion3 Jun 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for LaryngoscopyStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hee-Soo Kim, Seoul National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03241979
- Sponsor's protocol ID
- H1706-204-866
- Status last verified
- Apr 2021
- First submitted
- 28 Jul 2017
- Last updated
- 21 Apr 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Kim EH, Ji SH, Lee JH, Kim JT, Jang YE, Kwon SK, Kim HS. Use of high-flow nasal oxygen in spontaneously breathing pediatric patients undergoing tubeless airway surgery: A prospective observational study. Medicine (Baltimore). 2022 Jul 8;101(27):e29520. doi: 10.1097/MD.0000000000029520.
PubMed 35801795
Study at a glance
From the registry record, last updated by the sponsor on 21 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Transnasal Humidified Rapid Insufflation Ventilator Exchange (THRIVE) on the Oxygenation in Pediatric Patients Under Tubeless Airway Surgery - a Physiologic Study
- ClinicalTrials.gov ID
- NCT03241979
- Acronym / sponsor ID
- H1706-204-866
- Conditions
- Laryngoscopy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Study start
- 7 Aug 2017 (actual)
- Primary completion
- 3 Jun 2019 (actual)
- Study completion
- 3 Jun 2019 (actual)
- First posted
- 8 Aug 2017 (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 High-flow rapid-insufflation ventilatory exchange (THRIVE) has been shown to benefit oxygenation, ventilation and upper airway patency in a range of clinical scenarios, however its use in spontaneously breathing pediatric patients undergoing tubeless airway surgery has not been described. This is a physiologic study that evaluates the feasibility of THRIVE during pediatric airway surgery under self-respiration.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| laryngeal microsurgery | – | – |
Who may qualify
- Ages
- Up to 6 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- pediatric patients
Key inclusion criteria (1 listed)
- pediatric patients undergoing laryngeal microsurgery with spontaneous ventilation
Key exclusion criteria (1 listed)
- Severe gastrointestinal reflux disease Neuromuscular disease Central hypoventilation
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
number of low saturation events
Time frame: Intraoperative
oxygen saturation decrease lower than 90%
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 Apr 2021.
- Derived from this study: PubMed 35801795Kim EH, Ji SH, Lee JH, Kim JT, Jang YE, Kwon SK, Kim HS. Use of high-flow nasal oxygen in spontaneously breathing pediatric patients undergoing tubeless airway surgery: A prospective observational study. Medicine (Baltimore). 2022 Jul 8;101(27):e29520. doi: 10.1097/MD.0000000000029520.
- Individual participant dataSharing planned: Undecided
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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?
An observational study of Laryngoscopy, 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 1 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 Apr 2021. 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?
number of low saturation events (time frame: Intraoperative). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03241979, which also lists 1 linked publication.
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 Apr 2021.