HypoxemiaNCT04238351
Transnasal Humidified Rapid Insufflation System for Intubation
A study testing Transnasal humidified rapid insufflation ventilator exchange and Conventional face mask in people with Hypoxemia, run by Gachon University Gil Medical Center.
Trial summary
Transnasal humidified rapid insufflation ventilator exchange (THRIVE) or not during the anesthesia induction Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Hypoxemia
- What is being tested?
- Transnasal humidified rapid insufflation ventilator exchange and Conventional face mask
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- No sites listed yet
- Study dates
- 25 Feb 2020to 31 Dec 2020
- 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 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients who scheduled for elective lung surery with one lung ventilation
Who cannot join
- suspicious difficult intubation (BMI >35kg/m2, mouth opening < 3 finger, Mallampati G >3), Room air SpO2 < 90%, active pulmonary infection, emergency operation, pregnancy
About this study
Official title: Effect of Transnasal Humidified Rapid Insufflation Ventilator Exchange During Anesthesia Induction With Double Lumen Endotracheal Tube
Transnasal humidified rapid insufflation ventilator exchange (THRIVE) or not during the anesthesia induction
Read the detailed description
Control group-usual mask ventilation during apnea for anesthetic intubation and check tube positioning THRIVE group-applying THRIVE during apnea for anesthetic intubation and check tube positioning
- Conditions
- Hypoxemia
- Being tested
- Transnasal humidified rapid insufflation ventilator exchange, Conventional face mask
- Medical subject headings
- Hypoxia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transnasal humidified rapid insufflation ventilator exchangeDevice
applying 40L of oxygen for 1min and afte that increase oxygen flow up to 70L for 1 min.
Conventional face maskDevice
applying oxygen using usual face mask
| Study group | Role | What they receive |
|---|---|---|
| Control | Experimental | usual mask ventilation during anethesia induction Receives: Device: Conventional face mask |
| THRIVE | Active comparator | Applying Transnasal humidified rapid insufflation ventilator exchange during anesthesia induction Receives: Device: Transnasal humidified rapid insufflation ventilator exchange |
What is being measured
The primary outcome is the main question the study is designed to answer.
Desaturation
number of patients who experienced SpO2 under 93%
Measured: during the anesthesia induciton
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2020
- Study start25 Feb 2020 (estimated)
- Primary completion30 Nov 2020 (estimated)
- Study completion31 Dec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypoxemiaStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Applying Transnasal humidified rapid insufflation ventilator exchange
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Gachon University Gil Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Youn Yi Jo, Gachon University Gil Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04238351
- Sponsor's protocol ID
- Gil2019-2
- Status last verified
- Feb 2020
- First submitted
- 20 Jan 2020
- Last updated
- 18 Feb 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Transnasal Humidified Rapid Insufflation Ventilator Exchange During Anesthesia Induction With Double Lumen Endotracheal Tube
- ClinicalTrials.gov ID
- NCT04238351
- Acronym / sponsor ID
- Gil2019-2
- Conditions
- Hypoxemia
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Gachon University Gil Medical CenterUniversity, hospital or other
- Study start
- 25 Feb 2020 (estimated)
- Primary completion
- 30 Nov 2020 (estimated)
- Study completion
- 31 Dec 2020 (estimated)
- First posted
- 23 Jan 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 ventilator exchange (THRIVE) or not during the anesthesia induction
Detailed description
Control group-usual mask ventilation during apnea for anesthetic intubation and check tube positioning THRIVE group-applying THRIVE during apnea for anesthetic intubation and check tube positioning
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
- Model description
- Applying Transnasal humidified rapid insufflation ventilator exchange
| Arm | Type | Receives |
|---|---|---|
| Control | Experimental | Device: Conventional face maskusual mask ventilation during anethesia induction |
| THRIVE | Active comparator | Device: Transnasal humidified rapid insufflation ventilator exchangeApplying Transnasal humidified rapid insufflation ventilator exchange during anesthesia induction |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients who scheduled for elective lung surery with one lung ventilation
Key exclusion criteria (1 listed)
- suspicious difficult intubation (BMI >35kg/m2, mouth opening < 3 finger, Mallampati G >3), Room air SpO2 < 90%, active pulmonary infection, emergency operation, pregnancy
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 |
|---|---|---|
| Transnasal humidified rapid insufflation ventilator exchangeapplying 40L of oxygen for 1min and afte that increase oxygen flow up to 70L for 1 min. | Device | THRIVE |
| Conventional face maskapplying oxygen using usual face mask | Device | Control |
Primary outcome
Desaturation
Time frame: during the anesthesia induciton
number of patients who experienced SpO2 under 93%
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Feb 2020.
- Individual participant dataSharing planned: No
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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.
Questions about this trial
What is this clinical trial studying?
A study testing Transnasal humidified rapid insufflation ventilator exchange and Conventional face mask in people with Hypoxemia, run by Gachon University Gil Medical Center.
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: status not confirmed, as of the sponsor's last update on 18 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.
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?
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?
Desaturation (time frame: during the anesthesia induciton). 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 18 Feb 2020; AzTrials last refreshed its copy on 6 Nov 2026.