SurgeryNCT03355547
Observation of Atelectasis Using Lung Ultrasonography in Children Undergoing General Anesthesia: the Cohort Study for Evaluation of the Relationship Between the Incidence and Severity of Upper Respiratory Tract Infection and the Magnitude of Anesthesia-induced Atelectasis
An observational study of Surgery, run by Yonsei University at 1 site in South Korea.
Trial summary
Pediatric patients between 6months and 6years old will be included. They are scheduled for elective general or urologic surgery at a single tertiary medical center. Before the operation, the researcher interviews the parents of the pediatric patients to check whether they have the upper respiratory tract infection and… Read more about this study
- Who is it for?
- Ages 6 months to 6 years
- Conditions the study is for
- Surgery
- What is being tested?
- questionnaire about the severity of their symptoms of upper respiratory tract infection
- How many people
- 261 participants
- Where
- 1 siteSouth Korea
- Study dates
- 28 Sep 2017to 1 Feb 2019
- Phase
- Observational
- 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 6 months to 6 years
- All sexes
- No healthy volunteers
- Child
Study population: Pediatric patients between 6months and 6years old scheduled for elective general or urologic surgery at a single thetiary medical center.
Who may be able to join
- Age: Pediatric patients older than 6 months and younger than 6 years
- scheduled for elective pediatric general or urology surgery.
Who cannot join
- undergoing laparoscopic surgery
- pediatric patients with lower respiratory tract infection( pneumonia , bronchiolitis )
- patients with bronchopulmonary dysplasia history
- hemodynamic instability
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Department of Anesthesiology and Pain Medicine Anesthesia and Pain Research Institute Yonsei University College of Medicine
Seoul, 120-752
About this study
Pediatric patients between 6months and 6years old will be included. They are scheduled for elective general or urologic surgery at a single tertiary medical center. Before the operation, the researcher interviews the parents of the pediatric patients to check whether they have the upper respiratory tract infection and asks them to fill out a questionnaire about the severity of their symptoms. The researcher will get the symptom score of the upper respiratory tract infection in the questionnaire. The degree of anesthesia induced atelectasis is measured using lung ultrasound. Pulmonary ultrasound is performed after endotracheal intubation and at the end of the operation dividing the patient's thorax into 12 regions. The investigator grades the degree of atelectasis at each region form 0 to 3 points. After the end of the operation, check whether the respiratory adverse effects occurred during emergence and recovery at the post anesthesia care unit.
- Conditions
- Surgery
- Being tested
- questionnaire about the severity of their symptoms of upper respiratory tract infection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
questionnaire about the severity of their symptoms of upper respiratory tract infectionOther
Before the operation, the researcher interviews the parents of the pediatric patients to check whether they have the upper respiratory tract infection and asks them to fill out a questionnaire about the severity of their symptoms. The questionnaire consists of 8 types of symptom about upper respiratory infections and each symptom was checked from 0 to 3 according to severity by their patients.
| Study group | Role | What they receive |
|---|---|---|
| no URI (upper respiratory tract infection) symptoms | Patients without upper respiratory tract infection symptoms Receives: Other: questionnaire about the severity of their symptoms of upper respiratory tract infection | |
| URI (upper respiratory tract infection) symptoms | Patients with upper respiratory tract infection symptoms Receives: Other: questionnaire about the severity of their symptoms of upper respiratory tract infection |
What is being measured
The primary outcome is the main question the study is designed to answer.
The degree of atelectasis due to general anesthesia using lung ultrasound
Anesthesia induced atelectasis is diagnosed when the ultrasound findings as B-line (appears hyperechoic lines perpendicular to the pleura) and consolidation(loss of pleural line and hypoechoic area) are identified. The chest is divided into 12 regions: three longitudinal lines (parasternal, anterior, and posterior axillary) and two axial lines (above the diaphragm, and 1cm above the nipples) in each hemithorax. The investigator grades the degree of atelectasis at each region form 0 to 3 points. The degree of juxtapleural consolidation was graded: (a0) no consolidation; (a1) minimal juxtapleural consolidation; (a2) small-sized consolidation(<50%); and (a3) large-sized consolidation(>50%). The degree of B-lines was divided into four grades: (b0) fewer than three isolated B-lines; (b1) multiple well-defined B-lines; (b2) multiple coalescent B-lines; and (b3) white lung.
Measured: The investigator will measure the degree of atelectasis using lung ultrasound at 2 minutes after endotracheal intubation and at 5minutes the end of the operation.
Secondary outcomes (2)
Occurrence of respiratory adverse effects after the operation
After the end of the operation, check whether the respiratory adverse effects occurred when the patient is extubated and 10, 30 minutes after extubation at the post anesthesia care unit. Respiratory adverse effects are bronchospasm and laryngospasm. We analyze the symptom score of upper respiratory tract infection in pediatric patients who showed respiratory adverse events and suggest the cut off value of the score with high risk of respiratory adverse events by multivariate logistic regression.
Measured: 10 minutes after extubation at the post anesthesia care unit
Occurrence of respiratory adverse effects after the operation
After the end of the operation, check whether the respiratory adverse effects occurred when the patient is extubated and 10, 30 minutes after extubation at the post anesthesia care unit. Respiratory adverse effects are bronchospasm and laryngospasm. We analyze the symptom score of upper respiratory tract infection in pediatric patients who showed respiratory adverse events and suggest the cut off value of the score with high risk of respiratory adverse events by multivariate logistic regression.
Measured: 30 minutes after extubation at the post anesthesia care unit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Nov 2017
- Study start28 Sep 2017
- Primary completion1 Feb 2019
- Study completion1 Feb 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 SurgeryStudies of the same condition, open and under way.
- More trials run by Yonsei UniversityThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 261 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yonsei University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03355547
- Sponsor's protocol ID
- 4-2017-0766
- Status last verified
- May 2019
- First submitted
- 22 Nov 2017
- Last updated
- 6 May 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Lee HM, Byon HJ, Kim N, Gleich SJ, Flick RP, Lee JR. Effect of upper respiratory infection on anaesthesia induced atelectasis in paediatric patients. Sci Rep. 2021 Mar 16;11(1):5981. doi: 10.1038/s41598-021-85378-0.
PubMed 33727626
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Observation of Atelectasis Using Lung Ultrasonography in Children Undergoing General Anesthesia: the Cohort Study for Evaluation of the Relationship Between the Incidence and Severity of Upper Respiratory Tract Infection and the Magnitude of Anesthesia-induced Atelectasis
- ClinicalTrials.gov ID
- NCT03355547
- Acronym / sponsor ID
- 4-2017-0766
- Conditions
- Surgery
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 261 participants (actual)
- Lead sponsor
- Yonsei UniversityUniversity, hospital or other
- Study start
- 28 Sep 2017 (actual)
- Primary completion
- 1 Feb 2019 (actual)
- Study completion
- 1 Feb 2019 (actual)
- First posted
- 28 Nov 2017 (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.
Pediatric patients between 6months and 6years old will be included. They are scheduled for elective general or urologic surgery at a single tertiary medical center. Before the operation, the researcher interviews the parents of the pediatric patients to check whether they have the upper respiratory tract infection and asks them to fill out a questionnaire about the severity of their symptoms. The researcher will get the symptom score of the upper respiratory tract infection in the questionnaire. The degree of anesthesia induced atelectasis is measured using lung ultrasound. Pulmonary ultrasound is performed after endotracheal intubation and at the end of the operation dividing the patient's thorax into 12 regions. The investigator grades the degree of atelectasis at each region form 0 to 3 points. After the end of the operation, check whether the respiratory adverse effects occurred during emergence and recovery at the post anesthesia care unit.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| no URI (upper respiratory tract infection) symptoms | – | Other: questionnaire about the severity of their symptoms of upper respiratory tract infectionPatients without upper respiratory tract infection symptoms |
| URI (upper respiratory tract infection) symptoms | – | Other: questionnaire about the severity of their symptoms of upper respiratory tract infectionPatients with upper respiratory tract infection symptoms |
Who may qualify
- Ages
- 6 months to 6 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Pediatric patients between 6months and 6years old scheduled for elective general or urologic surgery at a single thetiary medical center.
Key inclusion criteria (2 listed)
- Age: Pediatric patients older than 6 months and younger than 6 years
- scheduled for elective pediatric general or urology surgery.
Key exclusion criteria (4 listed)
- undergoing laparoscopic surgery
- pediatric patients with lower respiratory tract infection( pneumonia , bronchiolitis )
- patients with bronchopulmonary dysplasia history
- hemodynamic instability
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 |
|---|---|---|
| questionnaire about the severity of their symptoms of upper respiratory tract infectionBefore the operation, the researcher interviews the parents of the pediatric patients to check whether they have the upper respiratory tract infection and asks them to fill out a questionnaire about the severity of their symptoms. The questionnaire consists of 8 types of symptom about upper respiratory infections and each symptom was checked from 0 to 3 according to severity by their patients. | Other | URI (upper respiratory tract infection) symptoms, no URI (upper respiratory tract infection) symptoms |
Primary outcome
The degree of atelectasis due to general anesthesia using lung ultrasound
Time frame: The investigator will measure the degree of atelectasis using lung ultrasound at 2 minutes after endotracheal intubation and at 5minutes the end of the operation.
Anesthesia induced atelectasis is diagnosed when the ultrasound findings as B-line (appears hyperechoic lines perpendicular to the pleura) and consolidation(loss of pleural line and hypoechoic area) are identified. The chest is divided into 12 regions: three longitudinal lines (parasternal, anterior, and posterior axillary) and two axial lines (above the diaphragm, and 1cm above the nipples) in each hemithorax. The investigator grades the degree of atelectasis at each region form 0 to 3 points. The degree of juxtapleural consolidation was graded: (a0) no consolidation; (a1) minimal juxtapleural consolidation; (a2) small-sized consolidation(<50%); and (a3) large-sized consolidation(>50%). The degree of B-lines was divided into four grades: (b0) fewer than three isolated B-lines; (b1) multiple well-defined B-lines; (b2) multiple coalescent B-lines; and (b3) white lung.
2 secondary outcomes
Occurrence of respiratory adverse effects after the operation
Time frame: 10 minutes after extubation at the post anesthesia care unit
Occurrence of respiratory adverse effects after the operation
Time frame: 30 minutes after extubation at the post anesthesia care unit
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 6 May 2019.
- Derived from this study: PubMed 33727626Lee HM, Byon HJ, Kim N, Gleich SJ, Flick RP, Lee JR. Effect of upper respiratory infection on anaesthesia induced atelectasis in paediatric patients. Sci Rep. 2021 Mar 16;11(1):5981. doi: 10.1038/s41598-021-85378-0.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Surgery, run by Yonsei University 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 4 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 6 May 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. 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?
The degree of atelectasis due to general anesthesia using lung ultrasound (time frame: The investigator will measure the degree of atelectasis using lung ultrasound at 2 minutes after endotracheal intubation and at 5minutes the end of the operation.). 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 NCT03355547, 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 6 May 2019.