AtelectasisNCT03739697
Effect of Spontaneous Breathing on Atelectasis During Induction of General Anesthesia in Patients in Infants
A study testing spontaneous breathing in people with Atelectasis, run by Seoul National University Hospital at 1 site in South Korea.
Trial summary
spontaneous breathing on occurrence of atelectsis in infants Read more about this study
- Who is it for?
- Ages 1 month to 12 months
- Conditions the study is for
- Atelectasis
- What is being tested?
- spontaneous breathing
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteSouth Korea
- Study dates
- 1 Dec 2018to 16 Dec 2019
- 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 12 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- general anesthesia
Who cannot join
- heart or lung problems
- prematurity
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Seoul National University Children's Hospital
spontaneous breathing on occurrence of atelectsis in infants
Read the detailed description
Keeping the spontaneous breathing during the anesthesia for 5 minutes and occurrence of atelectasis
- Conditions
- Atelectasis
- Being tested
- spontaneous breathing
- Medical subject headings
- Pulmonary Atelectasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
spontaneous breathingOther
spontaneous breathing during induction of anesthesia in infants
| Study group | Role | What they receive |
|---|---|---|
| spontaneous breathing | Active comparator | spontaneous breathing after adminitration of anesthetics Receives: Other: spontaneous breathing |
| mechanical ventilation | No intervention | mechanical ventilation after adminitration of anesthetics and neuromuscula blockade |
What is being measured
The primary outcome is the main question the study is designed to answer.
occurrence of atelectasis
ateletasis grada (> 2)
Measured: 5 minutes after administration of anesthetics
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Nov 2018
- Study start1 Dec 2018
- Primary completion16 Dec 2019
- Study completion16 Dec 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 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
- Single blind
- Who is masked
- Investigator
- Enrolment
- 60 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
- Investigators
- Hee-Soo Kim, Principal investigator, Seoul National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03739697
- Sponsor's protocol ID
- 1810-076-979
- Status last verified
- Apr 2020
- First submitted
- 9 Nov 2018
- Last updated
- 14 Apr 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Ji SH, Jang HS, Jang YE, Kim EH, Lee JH, Kim JT, Kim HS. Effect of spontaneous breathing on atelectasis during induction of general anaesthesia in infants: A prospective randomised controlled trial. Eur J Anaesthesiol. 2020 Dec;37(12):1150-1156. doi: 10.1097/EJA.0000000000001327.
PubMed 33009186
Study at a glance
From the registry record, last updated by the sponsor on 14 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Seoul National University Children's Hospital
- ClinicalTrials.gov ID
- NCT03739697
- Acronym / sponsor ID
- 1810-076-979
- Conditions
- Atelectasis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Study start
- 1 Dec 2018 (actual)
- Primary completion
- 16 Dec 2019 (actual)
- Study completion
- 16 Dec 2019 (actual)
- First posted
- 14 Nov 2018 (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.
spontaneous breathing on occurrence of atelectsis in infants
Detailed description
Keeping the spontaneous breathing during the anesthesia for 5 minutes and occurrence of atelectasis
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| spontaneous breathing | Active comparator | Other: spontaneous breathingspontaneous breathing after adminitration of anesthetics |
| mechanical ventilation | No intervention | –mechanical ventilation after adminitration of anesthetics and neuromuscula blockade |
Who may qualify
- Ages
- 1 month to 12 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- general anesthesia
Key exclusion criteria (2 listed)
- heart or lung problems
- prematurity
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 |
|---|---|---|
| spontaneous breathingspontaneous breathing during induction of anesthesia in infants | Other | spontaneous breathing |
Primary outcome
occurrence of atelectasis
Time frame: 5 minutes after administration of anesthetics
ateletasis grada (> 2)
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 14 Apr 2020.
- Derived from this study: PubMed 33009186Ji SH, Jang HS, Jang YE, Kim EH, Lee JH, Kim JT, Kim HS. Effect of spontaneous breathing on atelectasis during induction of general anaesthesia in infants: A prospective randomised controlled trial. Eur J Anaesthesiol. 2020 Dec;37(12):1150-1156. doi: 10.1097/EJA.0000000000001327.
- Individual participant dataSharing planned: No
Related trials for Atelectasis
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Surfactant, Respiratory Distress Syndrome (Neonatal)
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Stepwise PEEP vs Sustained Inflation in Bariatric Surgery Patients
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Bedside Assessment of Right Ventricular Output Lying in Prone Or Supine
Right Ventricular Function, Prone Position
Recruiting
Bronchoscopic Airway Clearance for Improving Lung Aeration in Mechanically Ventilated Patients With Atelectasis
Atelectasis, Mechanical Ventilation
Not yet recruitingObservational study
Chest Ultrasound as Diagnostic and Prognostic Tool in Neonatal RDS
Respiratory Distress Syndrome, Newborn, Neonatal Respiratory Distress
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.
Hee-Soo Kim 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 spontaneous breathing 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 2 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 14 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?
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?
occurrence of atelectasis (time frame: 5 minutes after administration of anesthetics). 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 NCT03739697, 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 14 Apr 2020.