Atelectasis, Postoperative PulmonaryNCT05821114
End-Expiratory Lung Volume in Children Awakening From Propofol Anesthesia
A study testing Head elevation_H, Supine_H and Head elevation_L in people with Atelectasis, Postoperative Pulmonary, run by Seoul National University Hospital at 1 site in South Korea.
Trial summary
The goal of this pilot randomized clinical trial is to test the effects of high flow nasal oxygen and head elevation during awakening from propofol anesthesia in pediatric patients undergoing airway surgery. Read more about this study
- Who is it for?
- Ages 1 month to 7 years
- Conditions the study is for
- Atelectasis, Postoperative Pulmonary
- What is being tested?
- Head elevation_H, Supine_H and Head elevation_L
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 52 participants
- Where
- 1 siteSouth Korea
- Study dates
- 7 Apr 2023to 31 Dec 2024
- 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 month to 7 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Pediatric patients undergoing airway surgery with high flow nasal oxygen
Who cannot join
- Loss of spontaneous ventilation during surgery
- less than 1 months
- cyanotic patients
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Hee-Soo Kim
Seoul, 03080
Hee-Soo Kim, MD.PhD, 08201052878006, dami0605@snu.ac.kr
Eun-hee Kim, MD. PhD, 82-2-2072-3661, beloveun@snu.ac.kr
About this study
Official title: The Effects of High-Flow Nasal Cannula and Body Position On Atelectasis Using Electric Impedance Tomography in Children Awakening From Propofol Anesthesia: A Pilot Randomized Controlled Trial.
The goal of this pilot randomized clinical trial is to test the effects of high flow nasal oxygen and head elevation during awakening from propofol anesthesia in pediatric patients undergoing airway surgery.
The main question[s] it aims to answer are:
Read more
- High flow oxygen can decrease the occurence of atelectasis during awakening from propofol anesthesia in pediatric patients?
- Head elevation can decrease the occurence of atelectasis during awakening from propofol anesthesia in pediatric patients?
Researchers will compare high flow oxygen vs low flow oxygen group to see if the use of high flow oxygen decrease the occurence of atelectasis during awakening from propofol anesthesia.
And in each group, the patients will be assigned to supine position vs head elevation position to compare the effects of head elevation during awakening from propofol anesthesia.
- Conditions
- Atelectasis, Postoperative Pulmonary
- Being tested
- Head elevation_H, Supine_H, Head elevation_L, Supine_L
- Medical subject headings
- Pulmonary Atelectasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Head elevation_HOther
High flow_Head-elevation
Supine_HOther
High flow_Supine
Head elevation_LOther
Low flow_head elevation
Supine_LOther
Low flow_supine
| Study group | Role | What they receive |
|---|---|---|
| high flow oxygen | Experimental | Oxygen supply (2L/kg/min.) during awakening from propofol anesthesia Receives: Other: Head elevation_H; Other: Supine_H |
| Low flow oxygen | Active comparator | Oxygen supply (0.3L/kg/min.) during awakening from propofol anesthesia Receives: Other: Head elevation_L; Other: Supine_L |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in Electric Impedance Tomography parameter
Measured: from induction of anesthesia to end of operation, about 3 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Apr 2023
- Study start7 Apr 2023
- Primary completion31 Dec 2024 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atelectasis, Postoperative PulmonaryStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 52 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
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05821114
- Sponsor's protocol ID
- 2302-129-1408
- Status last verified
- Apr 2023
- First submitted
- 7 Apr 2023
- Last updated
- 20 Apr 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 20 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of High-Flow Nasal Cannula and Body Position On Atelectasis Using Electric Impedance Tomography in Children Awakening From Propofol Anesthesia: A Pilot Randomized Controlled Trial.
- ClinicalTrials.gov ID
- NCT05821114
- Acronym / sponsor ID
- 2302-129-1408
- Conditions
- Atelectasis, Postoperative Pulmonary
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 52 participants (estimated)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Study start
- 7 Apr 2023 (actual)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 20 Apr 2023 (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.
The goal of this pilot randomized clinical trial is to test the effects of high flow nasal oxygen and head elevation during awakening from propofol anesthesia in pediatric patients undergoing airway surgery.
The main question[s] it aims to answer are:
- High flow oxygen can decrease the occurence of atelectasis during awakening from propofol anesthesia in pediatric patients?
- Head elevation can decrease the occurence of atelectasis during awakening from propofol anesthesia in pediatric patients?
Researchers will compare high flow oxygen vs low flow oxygen group to see if the use of high flow oxygen decrease the occurence of atelectasis during awakening from propofol anesthesia.
And in each group, the patients will be assigned to supine position vs head elevation position to compare the effects of head elevation during awakening from propofol anesthesia.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| high flow oxygen | Experimental | Other: Head elevation_H, Other: Supine_HOxygen supply (2L/kg/min.) during awakening from propofol anesthesia |
| Low flow oxygen | Active comparator | Other: Head elevation_L, Other: Supine_LOxygen supply (0.3L/kg/min.) during awakening from propofol anesthesia |
Who may qualify
- Ages
- 1 month to 7 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Pediatric patients undergoing airway surgery with high flow nasal oxygen
Key exclusion criteria (3 listed)
- Loss of spontaneous ventilation during surgery
- less than 1 months
- cyanotic patients
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 |
|---|---|---|
| Head elevation_HHigh flow_Head-elevation | Other | high flow oxygen |
| Supine_HHigh flow_Supine | Other | high flow oxygen |
| Head elevation_LLow flow_head elevation | Other | Low flow oxygen |
| Supine_LLow flow_supine | Other | Low flow oxygen |
Primary outcome
Changes in Electric Impedance Tomography parameter
Time frame: from induction of anesthesia to end of operation, about 3 hours
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Apr 2023.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Head elevation_H, Supine_H and Head elevation_L in people with Atelectasis, Postoperative Pulmonary, 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 3 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 20 Apr 2023. 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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in Electric Impedance Tomography parameter (time frame: from induction of anesthesia to end of operation, about 3 hours). 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 20 Apr 2023; AzTrials last refreshed its copy on 7 Nov 2026.