DesaturationNCT04152733
Effect of High Flow Nasal Cannula on Oxygenation During Urodynamic Study in Pediatric Population
A study testing High flow nasal cannula in people with Desaturation, run by Seoul National University Hospital at 1 site in South Korea.
Trial summary
To evaluate the effect of high flow nasal cannula for prevention of hypoxia during deep sedation in pediatric population Read more about this study
- Who is it for?
- Ages Up to 6 years
- Conditions the study is for
- Desaturation
- What is being tested?
- High flow nasal cannula
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 82 participants
- Where
- 1 siteSouth Korea
- Study dates
- 23 Mar 2020to 30 Dec 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 Up to 6 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Children aged <7 years
- ASA class I, II
Who cannot join
- Respiratory disease
- Pneumothorax
- Increased ICP
- Nasal bleeding
- Previous airway surgery
- Trauma
- Pulmonary hypertension
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Seoul National University Hospital
Seoul, 110-744
Jin-Tae Kim, Pf., +82-2-2072-3295, jintae73@gmail.com
About this study
To evaluate the effect of high flow nasal cannula for prevention of hypoxia during deep sedation in pediatric population
- Conditions
- Desaturation
- Being tested
- High flow nasal cannula
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High flow nasal cannulaDevice
Oxygen is supplied via high flow nasal cannula. Heated air (2L/kg/min) is administered using Optiflow device (Fisher and Paykel Healthcare, Auckland, New Zealand).
| Study group | Role | What they receive |
|---|---|---|
| Control group | No intervention | Children in the control group receive oxygen via conventional nasal cannula during deep sedation. Oxygen flow is determined to set the fraction of inspired oxygen of 50%. |
| High flow (HF) group | Experimental | Children in the HF group receive oxygen via high flow nasal cannula during deep sedation. Fraction of inspired oxygen is set to 50%. Receives: Device: High flow nasal cannula |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of desaturation
Incidence of peripheral pulse oximeter value lower than 95%
Measured: During deep sedation (during approximately 1 hour after propofol infusion)
Secondary outcomes (6)
Minimum pulse oximeter value
Measured: During deep sedation (during approximately 1 hour after propofol infusion)
Incidence of peripheral pulse oximeter value lower than 90%
Measured: During deep sedation (during approximately 1 hour after propofol infusion)
Incidence of changes in oxygen flow (control group) or FiO2 (HF group)
Measured: During deep sedation (during approximately 1 hour after propofol infusion)
percutaneous CO2 value
Measured: During deep sedation (during approximately 1 hour after propofol infusion)
Oxygen reserve index value
Measured: During deep sedation (during approximately 1 hour after propofol infusion)
Incidence of manual ventilation
Measured: During deep sedation (during approximately 1 hour after propofol infusion)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Nov 2019
- Study start23 Mar 2020
- Primary completion20 Nov 2021 (estimated)
- Study completion30 Dec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DesaturationStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 82 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jin-Tae Kim, Seoul National University Hospital
- Investigators
- Jin-Tae Kim, MD, PhD, Principal investigator, Seoul National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04152733
- Sponsor's protocol ID
- H1910-038-1068
- Status last verified
- Apr 2020
- First submitted
- 3 Nov 2019
- Last updated
- 22 Apr 2020
- Results posted
- No
- 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 22 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of High Flow Nasal Cannula on Oxygenation During Urodynamic Study in Pediatric Population
- ClinicalTrials.gov ID
- NCT04152733
- Acronym / sponsor ID
- H1910-038-1068
- Conditions
- Desaturation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 82 participants (estimated)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Study start
- 23 Mar 2020 (actual)
- Primary completion
- 20 Nov 2021 (estimated)
- Study completion
- 30 Dec 2021 (estimated)
- First posted
- 5 Nov 2019 (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.
To evaluate the effect of high flow nasal cannula for prevention of hypoxia during deep sedation in pediatric population
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control group | No intervention | –Children in the control group receive oxygen via conventional nasal cannula during deep sedation. Oxygen flow is determined to set the fraction of inspired oxygen of 50%. |
| High flow (HF) group | Experimental | Device: High flow nasal cannulaChildren in the HF group receive oxygen via high flow nasal cannula during deep sedation. Fraction of inspired oxygen is set to 50%. |
Who may qualify
- Ages
- Up to 6 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Children aged <7 years
- ASA class I, II
Key exclusion criteria (7 listed)
- Respiratory disease
- Pneumothorax
- Increased ICP
- Nasal bleeding
- Previous airway surgery
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 |
|---|---|---|
| High flow nasal cannulaOxygen is supplied via high flow nasal cannula. Heated air (2L/kg/min) is administered using Optiflow device (Fisher and Paykel Healthcare, Auckland, New Zealand). | Device | High flow (HF) group |
Primary outcome
Incidence of desaturation
Time frame: During deep sedation (during approximately 1 hour after propofol infusion)
Incidence of peripheral pulse oximeter value lower than 95%
6 secondary outcomes
Minimum pulse oximeter value
Time frame: During deep sedation (during approximately 1 hour after propofol infusion)
Incidence of peripheral pulse oximeter value lower than 90%
Time frame: During deep sedation (during approximately 1 hour after propofol infusion)
Incidence of changes in oxygen flow (control group) or FiO2 (HF group)
Time frame: During deep sedation (during approximately 1 hour after propofol infusion)
percutaneous CO2 value
Time frame: During deep sedation (during approximately 1 hour after propofol infusion)
Oxygen reserve index value
Time frame: During deep sedation (during approximately 1 hour after propofol infusion)
Incidence of manual ventilation
Time frame: During deep sedation (during approximately 1 hour after propofol infusion)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Apr 2020.
- Individual participant dataSharing planned: No
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PAH-SDB: Sleep-Disordered Breathing and Outcomes in Pulmonary Arterial Hypertension
Pulmonary Arterial Hypertension (PAH), Sleep-disordered Breathing (SDB)
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Cerebral Oximetry During Awake Carotid Endarterectomy
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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.
Jin-Tae Kim, MD, PhD principal investigator
Seoul National University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing High flow nasal cannula in people with Desaturation, 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 2 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 22 Apr 2020. 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 Jin-Tae Kim, MD, PhD (82-2-2072-3661, jintae73@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of desaturation (time frame: During deep sedation (during approximately 1 hour after propofol infusion)). 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 22 Apr 2020.