Pediatric Cardiac SurgeryNCT04208906
Masimo O3 Regional Oximetry Device in Pediatric Patients Undergoing Cardiac Surgery
A study testing Masimo O3 in people with Pediatric Cardiac Surgery, run by Seoul National University Hospital at 1 site in South Korea.
Trial summary
We evaluate the relationship between the regional tissue oxygenation value (ScO2 - cerebral, StO2 - lower limb) and mixed venous saturation (SvO2) and arterial oxygen saturation (SaO2) measured before and after correction surgery in pediatric patients undergoing cardiac surgery. Read more about this study
- Who is it for?
- Ages Up to 6 years
- Conditions the study is for
- Pediatric Cardiac Surgery
- What is being tested?
- Masimo O3
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteSouth Korea
- Study dates
- 16 Jan 2020to 5 Oct 2021
- 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 6 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- children under 7 years old
Who cannot join
- Hyperbilirubinemia
- Skin disease at sensor attachment site
- Single ventricle physiology
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Validation of Masimo O3 Regional Oximetry Device in Pediatric Patients Undergoing Cardiac Surgery
We evaluate the relationship between the regional tissue oxygenation value (ScO2 - cerebral, StO2 - lower limb) and mixed venous saturation (SvO2) and arterial oxygen saturation (SaO2) measured before and after correction surgery in pediatric patients undergoing cardiac surgery.
In addition, we compared the sCO2 and sTO2 with reference value which is calculated using SvO2 and SaO2.
- Conditions
- Pediatric Cardiac Surgery
- Being tested
- Masimo O3
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Masimo O3Device
After anesthesia induction, a masimo O3 sensors are attached to the forehead (ScO2) and the sole of the foot (StO2). About 0.4 ml blood samples are obtained from arterial line and central venous line at three epochs before and after cardiopulmonary bypass (total 6 times)
- T1: before cardiopulmonary bypass (CPB), fraction of inspired oxygen (FiO2) 0.2
- T2: before CPB, FiO2 0.5
- T3: before CPB, FiO2 0.8
- T4: after CPB, FiO2 0.8
- T5: after CPB, FiO2 0.5
- T6: after CPB, FiO2 0.2
Hemoglobin oxygen saturation values are confirmed in each sample (arterial sample: SaO2, venous sample: SvO2). Each O3 values (ScO2 and StO2) are compared to the values of SvO2, 0.7 × SvO2 + 0.3 × SaO2.
| Study group | Role | What they receive |
|---|---|---|
| Children with congenital cardiac disease | Experimental | Pediatric patients aged < 7 years undergoing cardiac surgery Receives: Device: Masimo O3 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Validation of Masimo O3 value
Comparison of ScO2 and StO2 to reference level (SvO2, 0.7×SvO2 + 0.3×SaO2)
Measured: During surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Dec 2019
- Study start16 Jan 2020
- Primary completion30 Sep 2021
- Study completion5 Oct 2021
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 Pediatric Cardiac SurgeryStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 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
- NCT04208906
- Sponsor's protocol ID
- H1911-099-1081
- Status last verified
- Oct 2021
- First submitted
- 20 Dec 2019
- Last updated
- 25 Oct 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Lee JH, Song IS, Kang P, Ji SH, Jang YE, Kim EH, Kim HS, Kim JT. Validation of the Masimo O3 regional oximetry device in pediatric patients undergoing cardiac surgery. J Clin Monit Comput. 2022 Dec;36(6):1703-1709. doi: 10.1007/s10877-022-00815-3. Epub 2022 Feb 15.
PubMed 35169968
Study at a glance
From the registry record, last updated by the sponsor on 25 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validation of Masimo O3 Regional Oximetry Device in Pediatric Patients Undergoing Cardiac Surgery
- ClinicalTrials.gov ID
- NCT04208906
- Acronym / sponsor ID
- H1911-099-1081
- Conditions
- Pediatric Cardiac Surgery
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Study start
- 16 Jan 2020 (actual)
- Primary completion
- 30 Sep 2021 (actual)
- Study completion
- 5 Oct 2021 (actual)
- First posted
- 23 Dec 2019 (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.
We evaluate the relationship between the regional tissue oxygenation value (ScO2 - cerebral, StO2 - lower limb) and mixed venous saturation (SvO2) and arterial oxygen saturation (SaO2) measured before and after correction surgery in pediatric patients undergoing cardiac surgery.
In addition, we compared the sCO2 and sTO2 with reference value which is calculated using SvO2 and SaO2.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Children with congenital cardiac disease | Experimental | Device: Masimo O3Pediatric patients aged < 7 years undergoing cardiac surgery |
Who may qualify
- Ages
- Up to 6 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- children under 7 years old
Key exclusion criteria (3 listed)
- Hyperbilirubinemia
- Skin disease at sensor attachment site
- Single ventricle physiology
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 |
|---|---|---|
| Masimo O3After anesthesia induction, a masimo O3 sensors are attached to the forehead (ScO2) and the sole of the foot (StO2). About 0.4 ml blood samples are obtained from arterial line and central venous line at three epochs before and after cardiopulmonary bypass (total 6 times) * T1: before cardiopulmonary bypass (CPB), fraction of inspired oxygen (FiO2) 0.2 * T2: before CPB, FiO2 0.5 * T3: before CPB, FiO2 0.8 * T4: after CPB, FiO2 0.8 * T5: after CPB, FiO2 0.5 * T6: after CPB, FiO2 0.2 Hemoglobin oxygen saturation values are confirmed in each sample (arterial sample: SaO2, venous sample: SvO2). Each O3 values (ScO2 and StO2) are compared to the values of SvO2, 0.7 × SvO2 + 0.3 × SaO2. | Device | Children with congenital cardiac disease |
Primary outcome
Validation of Masimo O3 value
Time frame: During surgery
Comparison of ScO2 and StO2 to reference level (SvO2, 0.7×SvO2 + 0.3×SaO2)
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 25 Oct 2021.
- Derived from this study: PubMed 35169968Lee JH, Song IS, Kang P, Ji SH, Jang YE, Kim EH, Kim HS, Kim JT. Validation of the Masimo O3 regional oximetry device in pediatric patients undergoing cardiac surgery. J Clin Monit Comput. 2022 Dec;36(6):1703-1709. doi: 10.1007/s10877-022-00815-3. Epub 2022 Feb 15.
Related trials for Pediatric Cardiac Surgery
Not yet recruiting
Starry-Sky Projection and Maternal Voice for Sleep After Pediatric Cardiac Surgery
Congenital Heart Disease (CHD), Postoperative Sleep
Active, not recruitingPhase 2/3
Equivalence of Oral Melatonin and Oral Midazolam in Preoperative Anxiolysis for Pediatric Fast-Track Cardiac Surgery
Comparative Effectiveness
Not yet recruiting
Recurrent Laryngeal Nerve Monitoring During Pediatric Aerodigestive Tract and Cardiac Surgery
Unilateral Vocal Cord Paralysis, Unilateral Vocal Cord Paresis
Not yet recruiting
Boyle-Davis Mouth Gag Timing in Pediatric Tonsil Surgery
Tonsillectomy and Adenotonsillectomy in Children
Active, not recruiting
Handheld US Device to Verify Vascular Cannulation
Surgery
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 Masimo O3 in people with Pediatric Cardiac Surgery, 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: finished, as of the sponsor's last update on 25 Oct 2021. 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?
Validation of Masimo O3 value (time frame: During surgery). 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 NCT04208906, 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 25 Oct 2021.