UltrasonographyLUSNCT02535013
Intraoperative Lung Ultrasound in Pediatric Patients
A study testing Lung ultrasound in people with Ultrasonography and Pediatrics, run by Seoul National University Hospital at 1 site in South Korea.
Trial summary
Investigators hypothesized that perioperative lung ultrasound would be beneficial in pediatric patients undergoing cardiac surgery compared to those who did not receive lung ultrasound. Read more about this study
- Who is it for?
- Ages Up to 5 years
- Conditions the study is for
- Ultrasonography, Pediatrics, Perioperative Period
- What is being tested?
- Lung ultrasound
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 122 participants
- Where
- 1 siteSouth Korea
- Study dates
- Aug 2015to Sep 2016
- 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
- Acyanotic congenital heart disease patients undergoing cardiac surgery under general anesthesia
Who cannot join
- History of surgery on the lungs
- Cyanotic congenital heart disease
- Abnormal preoperative chest radiograph findings including atelectasis, pneumothorax, pleural effusion, and pneumonia
- Considered inappropriate by the investigator
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Seoul National University Hospital
Seoul, Seoul, 110-744
About this study
Official title: Benefit of Intraoperative Lung Ultrasound in Pediatric Patients Undergoing Cardiac Surgery
Investigators hypothesized that perioperative lung ultrasound would be beneficial in pediatric patients undergoing cardiac surgery compared to those who did not receive lung ultrasound.
- Being tested
- Lung ultrasound
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lung ultrasoundDevice
Lung ultrasound with appropriate interventions depending on the ultrasound finding
| Study group | Role | What they receive |
|---|---|---|
| Control | Placebo comparator | No intervention during the perioperative period. Perform lung ultrasound twice only for the diagnostic purpose at the end of surgery and 6 to 12 hours after surgery in the intensive care unit. Receives: Device: Lung ultrasound |
| Ultrasound | Active comparator | Perform lung ultrasound three times during the perioperative period; after the induction of general anesthesia, at the end of surgery, and 6 to 12 hours after surgery in the intensive care unit. According to the lung ultrasound finding, conduct appropriate interventions such as, alveolar recruitment maneuver for atelectasis, or chest tube insertion for pneumothorax. Receives: Device: Lung ultrasound |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intraoperative incidence of pulse oximetry (SpO2) ≤ 95% (or 10% below the baseline value)
Measured: from the induction of general anesthesia until the end of the surgery, up to 24 hours
Postoperative incidence of SpO2 ≤ 95% (or 10% below the baseline value)
Measured: within the first day after surgery
Postoperative incidence of respiratory complications
Measured: within the first day after surgery
Secondary outcomes (4)
Intraoperative partial pressure of oxygen in arterial blood (PaO2) from arterial blood gas analysis
Measured: from the induction of general anesthesia until the end of the surgery, up to 24 hours
Postoperative partial pressure of oxygen in arterial blood (PaO2) from arterial blood gas analysis
Measured: within the first day after surgery
Initial SpO2 on arriving at pediatric intensive care unit
Measured: from the end of the surgery until postoperative 1 hour
Days needed to wean from mechanical ventilation
Measured: up to 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2015 (estimated)
- Study startAug 2015
- Primary completionAug 2016
- Study completionSep 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for UltrasonographyStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 122 participants (actual)
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, Principal investigator, Seoul National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02535013
- Sponsor's protocol ID
- 1507-062-687
- Acronym
- LUS
- Status last verified
- Dec 2016
- First submitted
- 24 Aug 2015
- Last updated
- 26 Dec 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
Lutterbey G, Wattjes MP, Doerr D, Fischer NJ, Gieseke J Jr, Schild HH. Atelectasis in children undergoing either propofol infusion or positive pressure ventilation anesthesia for magnetic resonance imaging. Paediatr Anaesth. 2007 Feb;17(2):121-5. doi: 10.1111/j.1460-9592.2006.02045.x.
PubMed 17238882Tusman G, Bohm SH, Tempra A, Melkun F, Garcia E, Turchetto E, Mulder PG, Lachmann B. Effects of recruitment maneuver on atelectasis in anesthetized children. Anesthesiology. 2003 Jan;98(1):14-22. doi: 10.1097/00000542-200301000-00006.
PubMed 12502973Bronicki RA, Chang AC. Management of the postoperative pediatric cardiac surgical patient. Crit Care Med. 2011 Aug;39(8):1974-84. doi: 10.1097/CCM.0b013e31821b82a6.
PubMed 21768801Vitale V, Ricci Z, Cogo P. Lung ultrasonography and pediatric cardiac surgery: first experience with a new tool for postoperative lung complications. Ann Thorac Surg. 2014 Apr;97(4):e121-4. doi: 10.1016/j.athoracsur.2014.01.060.
PubMed 24694455Acosta CM, Maidana GA, Jacovitti D, Belaunzaran A, Cereceda S, Rae E, Molina A, Gonorazky S, Bohm SH, Tusman G. Accuracy of transthoracic lung ultrasound for diagnosing anesthesia-induced atelectasis in children. Anesthesiology. 2014 Jun;120(6):1370-9. doi: 10.1097/ALN.0000000000000231.
PubMed 24662376
Study at a glance
From the registry record, last updated by the sponsor on 26 Dec 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Benefit of Intraoperative Lung Ultrasound in Pediatric Patients Undergoing Cardiac Surgery
- ClinicalTrials.gov ID
- NCT02535013
- Acronym / sponsor ID
- LUS / 1507-062-687
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 122 participants (actual)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Study start
- Aug 2015
- Primary completion
- Aug 2016 (actual)
- Study completion
- Sep 2016 (actual)
- First posted
- 28 Aug 2015 (estimated)
- 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.
Investigators hypothesized that perioperative lung ultrasound would be beneficial in pediatric patients undergoing cardiac surgery compared to those who did not receive lung ultrasound.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | Placebo comparator | Device: Lung ultrasoundNo intervention during the perioperative period. Perform lung ultrasound twice only for the diagnostic purpose at the end of surgery and 6 to 12 hours after surgery in the intensive care unit. |
| Ultrasound | Active comparator | Device: Lung ultrasoundPerform lung ultrasound three times during the perioperative period; after the induction of general anesthesia, at the end of surgery, and 6 to 12 hours after surgery in the intensive care unit. According to the lung ultrasound finding, conduct appropriate interventions such as, alveolar recruitment maneuver for atelectasis, or chest tube insertion for pneumothorax. |
Who may qualify
- Ages
- Up to 5 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Acyanotic congenital heart disease patients undergoing cardiac surgery under general anesthesia
Key exclusion criteria (4 listed)
- History of surgery on the lungs
- Cyanotic congenital heart disease
- Abnormal preoperative chest radiograph findings including atelectasis, pneumothorax, pleural effusion, and pneumonia
- Considered inappropriate by the investigator
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 |
|---|---|---|
| Lung ultrasoundLung ultrasound with appropriate interventions depending on the ultrasound finding | Device | Control, Ultrasound |
Primary outcome
Intraoperative incidence of pulse oximetry (SpO2) ≤ 95% (or 10% below the baseline value)
Time frame: from the induction of general anesthesia until the end of the surgery, up to 24 hours
Postoperative incidence of SpO2 ≤ 95% (or 10% below the baseline value)
Time frame: within the first day after surgery
Postoperative incidence of respiratory complications
Time frame: within the first day after surgery
4 secondary outcomes
Intraoperative partial pressure of oxygen in arterial blood (PaO2) from arterial blood gas analysis
Time frame: from the induction of general anesthesia until the end of the surgery, up to 24 hours
Postoperative partial pressure of oxygen in arterial blood (PaO2) from arterial blood gas analysis
Time frame: within the first day after surgery
Initial SpO2 on arriving at pediatric intensive care unit
Time frame: from the end of the surgery until postoperative 1 hour
Days needed to wean from mechanical ventilation
Time frame: up to 1 month
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 26 Dec 2016.
- Background: PubMed 17238882Lutterbey G, Wattjes MP, Doerr D, Fischer NJ, Gieseke J Jr, Schild HH. Atelectasis in children undergoing either propofol infusion or positive pressure ventilation anesthesia for magnetic resonance imaging. Paediatr Anaesth. 2007 Feb;17(2):121-5. doi: 10.1111/j.1460-9592.2006.02045.x.
- Background: PubMed 12502973Tusman G, Bohm SH, Tempra A, Melkun F, Garcia E, Turchetto E, Mulder PG, Lachmann B. Effects of recruitment maneuver on atelectasis in anesthetized children. Anesthesiology. 2003 Jan;98(1):14-22. doi: 10.1097/00000542-200301000-00006.
- Background: PubMed 21768801Bronicki RA, Chang AC. Management of the postoperative pediatric cardiac surgical patient. Crit Care Med. 2011 Aug;39(8):1974-84. doi: 10.1097/CCM.0b013e31821b82a6.
- Background: PubMed 24694455Vitale V, Ricci Z, Cogo P. Lung ultrasonography and pediatric cardiac surgery: first experience with a new tool for postoperative lung complications. Ann Thorac Surg. 2014 Apr;97(4):e121-4. doi: 10.1016/j.athoracsur.2014.01.060.
- Background: PubMed 24662376Acosta CM, Maidana GA, Jacovitti D, Belaunzaran A, Cereceda S, Rae E, Molina A, Gonorazky S, Bohm SH, Tusman G. Accuracy of transthoracic lung ultrasound for diagnosing anesthesia-induced atelectasis in children. Anesthesiology. 2014 Jun;120(6):1370-9. doi: 10.1097/ALN.0000000000000231.
- 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.
Jin-Tae 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 Lung ultrasound in people with Ultrasonography and Pediatrics, 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 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 26 Dec 2016. 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?
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?
Intraoperative incidence of pulse oximetry (SpO2) ≤ 95% (or 10% below the baseline value) (time frame: from the induction of general anesthesia until the end of the surgery, up to 24 hours). The study lists 3 primary outcomes in all. 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 NCT02535013, which also lists 5 linked publications.
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 26 Dec 2016.