Pulmonary ComplicationNCT03527862
Perioperative Lung Ultrasonography for Fast-track Cardiac Surgery
A study testing Treatment according to lung ultrasonography in people with Pulmonary Complication, run by Seoul National University Hospital at 1 site in South Korea.
Trial summary
The investigators evaluate the usefulness of lung ultrasonography in the perioperative period for postoperative outcomes in children undergoing fast track cardiac surgery. Read more about this study
- Who is it for?
- Ages Up to 5 years
- Conditions the study is for
- Pulmonary Complication
- What is being tested?
- Treatment according to lung ultrasonography
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 1 siteSouth Korea
- Study dates
- 8 May 2018to 20 Dec 2022
- 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 5 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Children receiving fast track cardiac surgery protocol
- = or < 5 years old
- Children with acyanotic heart disease
Who cannot join
- Previous history of lung resection surgery
- Preoperative chest x-ray abnormalities
- Postoperative cyanosis
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Seoul National University Hospital
Seoul, 03080
Jin-Tae Kim, Ph.D., +82-2-2072-3295, jintae73@gmail.com
About this study
Official title: The Effect of Perioperative Lung Ultrasonography on Postoperative Outcomes in Children Undergoing Fast-track Cardiac Surgery
The investigators evaluate the usefulness of lung ultrasonography in the perioperative period for postoperative outcomes in children undergoing fast track cardiac surgery.
Read the detailed description
Some appropriate intervention such as recruitment maneuver, chest tube insertion, or diuretics will be applied depending on lung ultrasound findings.
- Conditions
- Pulmonary Complication
- Being tested
- Treatment according to lung ultrasonography
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Treatment according to lung ultrasonographyOther
Appropriate treatment for atelectasis, pleural effusion, pulmonary edema, pneumothorax or pneumonia which are confirmed by lung ultrasonography
| Study group | Role | What they receive |
|---|---|---|
| Control group | No intervention | No intervention is performed. Lung ultrasonography is performed within 4 hours after surgery for diagnostic purpose. |
| lung ultrasonography group | Experimental | Lung ultrasonography is performed three times; after tracheal intubation, before surgery end, and within 4 hours after surgery. In this group, respiratory management is performed according to diagnosis. Receives: Other: Treatment according to lung ultrasonography |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative pulmonary complications
Pleural effusion, atelectasis, diaphragmatic dysfunction, pulmonary infection, embolism, respiratory failure, aspiration, pneumothorax, chylothorax, bronchospasm
Measured: Up to postoperative day 5
Secondary outcomes (5)
Duration of the use of inotropes
Duration of the use of inotropes
Measured: Up to postoperative day 5
Length of intensive care unit stay
Length of intensive care unit stay
Measured: up to postoperative day 5
Lung ultrasonography findings
Diagnostic lung ultrasonography
Measured: until 4 hours after surgery
ABGA result
arterial blood gas analysis results
Measured: within 4 hours after extubation
Duration of oxygen therapy
Measured: Up to postoperative day 5
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 May 2018
- Study start8 May 2018
- Primary completion20 Dec 2022 (estimated)
- Study completion20 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pulmonary ComplicationStudies 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
- 35 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
- NCT03527862
- Sponsor's protocol ID
- H1803-123-932
- Status last verified
- May 2022
- First submitted
- 24 Apr 2018
- Last updated
- 9 May 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Perioperative Lung Ultrasonography on Postoperative Outcomes in Children Undergoing Fast-track Cardiac Surgery
- ClinicalTrials.gov ID
- NCT03527862
- Acronym / sponsor ID
- H1803-123-932
- Conditions
- Pulmonary Complication
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 35 participants (estimated)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Study start
- 8 May 2018 (actual)
- Primary completion
- 20 Dec 2022 (estimated)
- Study completion
- 20 Dec 2022 (estimated)
- First posted
- 17 May 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.
The investigators evaluate the usefulness of lung ultrasonography in the perioperative period for postoperative outcomes in children undergoing fast track cardiac surgery.
Detailed description
Some appropriate intervention such as recruitment maneuver, chest tube insertion, or diuretics will be applied depending on lung ultrasound findings.
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 | –No intervention is performed. Lung ultrasonography is performed within 4 hours after surgery for diagnostic purpose. |
| lung ultrasonography group | Experimental | Other: Treatment according to lung ultrasonographyLung ultrasonography is performed three times; after tracheal intubation, before surgery end, and within 4 hours after surgery. In this group, respiratory management is performed according to diagnosis. |
Who may qualify
- Ages
- Up to 5 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Children receiving fast track cardiac surgery protocol
- = or < 5 years old
- Children with acyanotic heart disease
Key exclusion criteria (3 listed)
- Previous history of lung resection surgery
- Preoperative chest x-ray abnormalities
- Postoperative cyanosis
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 |
|---|---|---|
| Treatment according to lung ultrasonographyAppropriate treatment for atelectasis, pleural effusion, pulmonary edema, pneumothorax or pneumonia which are confirmed by lung ultrasonography | Other | lung ultrasonography group |
Primary outcome
Postoperative pulmonary complications
Time frame: Up to postoperative day 5
Pleural effusion, atelectasis, diaphragmatic dysfunction, pulmonary infection, embolism, respiratory failure, aspiration, pneumothorax, chylothorax, bronchospasm
5 secondary outcomes
Duration of the use of inotropes
Time frame: Up to postoperative day 5
Length of intensive care unit stay
Time frame: up to postoperative day 5
Lung ultrasonography findings
Time frame: until 4 hours after surgery
ABGA result
Time frame: within 4 hours after extubation
Duration of oxygen therapy
Time frame: Up to postoperative day 5
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 May 2022.
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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 Treatment according to lung ultrasonography in people with Pulmonary Complication, 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 3 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 9 May 2022. 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 (82-2-2072-3592, jintae73@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postoperative pulmonary complications (time frame: Up to postoperative day 5). 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 9 May 2022.