Anesthesia, GeneralNCT03156764
Qp/Qs Ratio by Noninvasive Methods in Children With Shunt Dependent Pulmonary Circulation
An observational study of Anesthesia, General and Congenital Heart Disease, run by Seoul National University Hospital at 1 site in South Korea.
Trial summary
In pediatric cardiac patients with shunt dependent pulmonary circulation, Qp/Qs ratio is a important parameter indicating the balance of pulmonaty and systemic circulation. This study will calculate Qp/Qs using variables measured using non-invasive monitors (cerebral oximeter and pulse oximeter). Read more about this study
- Who is it for?
- Ages Up to 18 years
- Conditions the study is for
- Anesthesia, General, Congenital Heart Disease, Blood Gas Monitoring, Transcutaneous
- What is being tested?
- Qp/Qs ratio monitoring
- How many people
- 29 participants
- Where
- 1 siteSouth Korea
- Study dates
- 23 May 2017to 21 Jul 2020
- 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 Up to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: pediatric cardiac patients scheduled to cardiac operation (shunt dependent pulmonary circulation)
Who may be able to join
- pediatric cardiac patients scheduled to cardiac operation (shunt dependent pulmonary circulation)
- preoperative SpO2<97%
Who cannot join
- unable to measure pulse oximeter or cerebral oximeter signal
- unable to measure SaO2 or SmvO2
- unstable vital sign
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Accuracy of Qp/Qs Calculated by Noninvasive Methods in Children With Shunt Dependent Pulmonary Circulation
In pediatric cardiac patients with shunt dependent pulmonary circulation, Qp/Qs ratio is a important parameter indicating the balance of pulmonaty and systemic circulation.
This study will calculate Qp/Qs using variables measured using non-invasive monitors (cerebral oximeter and pulse oximeter). This value will be compared with Qp/Qs calculated using variables obtained from blood sample.
Read the detailed description
Blood sampling will be performed in both arterial and central venous lines.
- Conditions
- Anesthesia, General, Congenital Heart Disease, Blood Gas Monitoring, Transcutaneous, Blood Gas Analysis
- Being tested
- Qp/Qs ratio monitoring
- Keywords
- Qp/Qs ratio, Pediatric congenital heart disease
- Medical subject headings
- Heart Defects, Congenital
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Qp/Qs ratio monitoringOther
Op/Qs -monitor will be calculated using SpO2 and cerebral oximetry Op/Qs -blood will be calculated using ABGA and VBGA
| Study group | Role | What they receive |
|---|---|---|
| Qp/Qs ratio monitoring | Qp/Qs ratio monitoring Receives: Other: Qp/Qs ratio monitoring |
What is being measured
The primary outcome is the main question the study is designed to answer.
the difference between Qp/Qs-monitor and Qp/Qs-blood
the difference between Qp/Qs-monitor (measure by pulse oximeter and NIRS) and Qp/Qs-blood (measured by blood gas analysis)
Measured: within 1 week after surgery
Secondary outcomes (2)
the difference between SpO2 and SaO2
the difference between SpO2 (measure by pulse oximeter)and SaO2 (measured by blood gas analysis)
Measured: within 1 week after surgery
the difference between cerebral oximeter score and and SmvO2
the difference between cerebral oximeter (measure by NIRS)and SmvO2 (measured by blood gas analysis)
Measured: within 1 week after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 May 2017
- Study start23 May 2017
- Primary completion21 Jul 2020
- Study completion21 Jul 2020
Why it stopped: More than 100 invasive and non-invasive QpQs data were collected
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anesthesia, GeneralStudies 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
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 29 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
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03156764
- Sponsor's protocol ID
- 2017-1046
- Status last verified
- Mar 2021
- First submitted
- 10 May 2017
- Last updated
- 17 Mar 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Accuracy of Qp/Qs Calculated by Noninvasive Methods in Children With Shunt Dependent Pulmonary Circulation
- ClinicalTrials.gov ID
- NCT03156764
- Acronym / sponsor ID
- 2017-1046
- Conditions
- Anesthesia, General, Congenital Heart Disease, Blood Gas Monitoring, Transcutaneous, Blood Gas Analysis
- Keywords
- Qp/Qs ratio, Pediatric congenital heart disease
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: More than 100 invasive and non-invasive QpQs data were collected
- Enrolment
- 29 participants (actual)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Study start
- 23 May 2017 (actual)
- Primary completion
- 21 Jul 2020 (actual)
- Study completion
- 21 Jul 2020 (actual)
- First posted
- 17 May 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.
In pediatric cardiac patients with shunt dependent pulmonary circulation, Qp/Qs ratio is a important parameter indicating the balance of pulmonaty and systemic circulation.
This study will calculate Qp/Qs using variables measured using non-invasive monitors (cerebral oximeter and pulse oximeter). This value will be compared with Qp/Qs calculated using variables obtained from blood sample.
Detailed description
Blood sampling will be performed in both arterial and central venous lines.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Qp/Qs ratio monitoring | – | Other: Qp/Qs ratio monitoringQp/Qs ratio monitoring |
Who may qualify
- Ages
- Up to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- pediatric cardiac patients scheduled to cardiac operation (shunt dependent pulmonary circulation)
Key inclusion criteria (2 listed)
- pediatric cardiac patients scheduled to cardiac operation (shunt dependent pulmonary circulation)
- preoperative SpO2<97%
Key exclusion criteria (3 listed)
- unable to measure pulse oximeter or cerebral oximeter signal
- unable to measure SaO2 or SmvO2
- unstable vital sign
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 |
|---|---|---|
| Qp/Qs ratio monitoringOp/Qs -monitor will be calculated using SpO2 and cerebral oximetry Op/Qs -blood will be calculated using ABGA and VBGA | Other | Qp/Qs ratio monitoring |
Primary outcome
the difference between Qp/Qs-monitor and Qp/Qs-blood
Time frame: within 1 week after surgery
the difference between Qp/Qs-monitor (measure by pulse oximeter and NIRS) and Qp/Qs-blood (measured by blood gas analysis)
2 secondary outcomes
the difference between SpO2 and SaO2
Time frame: within 1 week after surgery
the difference between cerebral oximeter score and and SmvO2
Time frame: within 1 week after surgery
Results and safety
The study was stopped early (reason given: More than 100 invasive and non-invasive QpQs data were collected). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Mar 2021.
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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 Anesthesia, General and Congenital Heart Disease, 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 2 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: stopped early, as of the sponsor's last update on 17 Mar 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 was stopped early (reason given: More than 100 invasive and non-invasive QpQs data were collected). Results are not available in the source record.
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 difference between Qp/Qs-monitor and Qp/Qs-blood (time frame: within 1 week after surgery). 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 17 Mar 2021.