AtelectasisNCT03817177
Application of High Flow Nasal Cannula for Prevention of Post-extubation Atelectasis in Children Undergoing Surgery
A study testing high flow nasal cannula oxygenation and nasal prong in people with Atelectasis, run by Seoul National University Hospital at 1 site in South Korea.
Trial summary
postoperative atelectasis observation by ultrasound after application of high flow nasal cannula oxygenation Read more about this study
- Who is it for?
- Ages 1 day to 2 years
- Conditions the study is for
- Atelectasis
- What is being tested?
- high flow nasal cannula oxygenation and nasal prong
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 1 siteSouth Korea
- Study dates
- 2 Mar 2019to 30 Jun 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 1 day to 2 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- general anesthesia
Who cannot join
- preterm
- bronchopulmonary dysplasia
- upper respiratory infection history
- respiratory disease
- cardiac surgery
Trial locations and contacts
1 site in 1 country.
Ji-Hyun Lee, MD, PHd contact
South Korea1 site, 1 recruiting
- Recruiting
Seoul National University Hospital
Seoul
Heesoo Kim
About this study
Official title: Seoul National University Hospital Department of Anesthesiology and Pain Medicine
postoperative atelectasis observation by ultrasound after application of high flow nasal cannula oxygenation
Read the detailed description
After surgery, postoperative atelectasis observation by ultrasound grading comparison between application of conventional nasal prong and high flow nasal cannula device
- Conditions
- Atelectasis
- Being tested
- high flow nasal cannula oxygenation, nasal prong
- Medical subject headings
- Pulmonary Atelectasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
high flow nasal cannula oxygenationProcedure or surgery
high flow nasal cannula application in PACU
nasal prongProcedure or surgery
conventional nasal prong application in PACU
| Study group | Role | What they receive |
|---|---|---|
| nasal prong | Placebo comparator | conventional nasal prong application after the surgery in postanesthetic care unit (PACU) Receives: Procedure: nasal prong |
| high flow nasal cannula oxygenation | Experimental | high flow nasal cannula application after the surgery in postanesthetic care unit (PACU) Receives: Procedure: high flow nasal cannula oxygenation |
What is being measured
The primary outcome is the main question the study is designed to answer.
lung sound score
0: Normal aeration (N): presence of lung sliding with A lines or fewer than two isolated B lines
- Moderate loss of lung aeration: multiple well-defined B lines (B1 lines)
- Severe loss of lung aeration: multiple coalescent B lines (B2 lines)
- Lung consolidation (C): the presence of a tissue pattern characterized by dynamic air
Measured: 30 minutes after arrival of postanesthetic care unit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jan 2019
- Study start2 Mar 2019
- Primary completion30 Jan 2021 (estimated)
- Study completion30 Jun 2021 (estimated)
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 AtelectasisStudies 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
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 80 participants (estimated)
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
- Investigators
- Hee-Soo Kim, Principal investigator, Seoul National University Children's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03817177
- Sponsor's protocol ID
- 1812-111-998
- Status last verified
- Mar 2019
- First submitted
- 23 Jan 2019
- Last updated
- 7 Mar 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Lee JH, Ji SH, Jang YE, Kim EH, Kim JT, Kim HS. Application of a High-Flow Nasal Cannula for Prevention of Postextubation Atelectasis in Children Undergoing Surgery: A Randomized Controlled Trial. Anesth Analg. 2021 Aug 1;133(2):474-482. doi: 10.1213/ANE.0000000000005285.
PubMed 33181560
Study at a glance
From the registry record, last updated by the sponsor on 7 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Seoul National University Hospital Department of Anesthesiology and Pain Medicine
- ClinicalTrials.gov ID
- NCT03817177
- Acronym / sponsor ID
- 1812-111-998
- Conditions
- Atelectasis
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Study start
- 2 Mar 2019 (actual)
- Primary completion
- 30 Jan 2021 (estimated)
- Study completion
- 30 Jun 2021 (estimated)
- First posted
- 25 Jan 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.
postoperative atelectasis observation by ultrasound after application of high flow nasal cannula oxygenation
Detailed description
After surgery, postoperative atelectasis observation by ultrasound grading comparison between application of conventional nasal prong and high flow nasal cannula device
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| nasal prong | Placebo comparator | Procedure: nasal prongconventional nasal prong application after the surgery in postanesthetic care unit (PACU) |
| high flow nasal cannula oxygenation | Experimental | Procedure: high flow nasal cannula oxygenationhigh flow nasal cannula application after the surgery in postanesthetic care unit (PACU) |
Who may qualify
- Ages
- 1 day to 2 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- general anesthesia
Key exclusion criteria (5 listed)
- preterm
- bronchopulmonary dysplasia
- upper respiratory infection history
- respiratory disease
- cardiac 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 cannula oxygenationhigh flow nasal cannula application in PACU | Procedure or surgery | high flow nasal cannula oxygenation |
| nasal prongconventional nasal prong application in PACU | Procedure or surgery | nasal prong |
Primary outcome
lung sound score
Time frame: 30 minutes after arrival of postanesthetic care unit
0: Normal aeration (N): presence of lung sliding with A lines or fewer than two isolated B lines 1. Moderate loss of lung aeration: multiple well-defined B lines (B1 lines) 2. Severe loss of lung aeration: multiple coalescent B lines (B2 lines) 3. Lung consolidation (C): the presence of a tissue pattern characterized by dynamic air
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Mar 2019.
- Derived from this study: PubMed 33181560Lee JH, Ji SH, Jang YE, Kim EH, Kim JT, Kim HS. Application of a High-Flow Nasal Cannula for Prevention of Postextubation Atelectasis in Children Undergoing Surgery: A Randomized Controlled Trial. Anesth Analg. 2021 Aug 1;133(2):474-482. doi: 10.1213/ANE.0000000000005285.
- 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.
Ji-Hyun Lee, MD, PHd contact
Hee-Soo Kim principal investigator
Seoul National University Children's 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 oxygenation and nasal prong in people with Atelectasis, 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 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: status not confirmed, as of the sponsor's last update on 7 Mar 2019. 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. Some participants in this study may receive a placebo. 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 Hee-Soo Kim, MD, Phd (0220723659, dami0605@snu.ac.kr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
lung sound score (time frame: 30 minutes after arrival of postanesthetic care unit). 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 NCT03817177, 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 7 Mar 2019.