MicrocirculationNCT06191913
Microcirculatory Alteration by a Vascular Occlusion Test Using Near-infrared Spectroscopy in Pediatric Cardiac Surgery
An observational study of Microcirculation, run by Kartal Kosuyolu Yuksek Ihtisas Education and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
Cardiopulmonary bypass cause microcirculatory alterations. Near infrared spectroscopic measurement of tissue oxygen saturation and vascular occlusion test are novel technologies for assessing the microcirculatory function of peripheral tissue specifically in patients undergoing cardiac surgery with cardiopulmonary… Read more about this study
- Who is it for?
- Ages 3 months to 3 years
- Conditions the study is for
- Microcirculation
- What is being tested?
- Near-infrared spectroscop
- Type of treatment
- Medical device
- How many people
- 120 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 18 Jan 2021to 11 Mar 2022
- How long will I take part?
- 1 Day
- 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 3 months to 3 years
- All sexes
- Child
Study population: 120 pediatric patients scheduled for elective cardiac surgery with CPB were enrolled
Who may be able to join
- Elective cardiac surgery with CPB
Who cannot join
- Skin and peripheral vascular disease,
- Taking medicine for vascular disease,
- Emergency procedures
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Assessment of Microcirculatory Alteration by a Vascular Occlusion Test Using Near-infrared Spectroscopy in Pediatric Cardiac Surgery:Effect of Cardiopulmonary Bypass
Cardiopulmonary bypass cause microcirculatory alterations. Near infrared spectroscopic measurement of tissue oxygen saturation and vascular occlusion test are novel technologies for assessing the microcirculatory function of peripheral tissue specifically in patients undergoing cardiac surgery with cardiopulmonary bypass
Read the detailed description
Cardiac surgery and cardiopulmonary bypass (CPB) procedures cause microcirculatory alterations, and microvascular alterations and the impairment of tissue oxygen saturation (StO2) after cardiac surgery with CPB have been associated with adverse patient outcomes. It has been shown that contact with foreign surfaces causes transient microcirculatory dysfunction and activation of the inflammatory and hemostatic systems and that tissue trauma and anesthesia also affect microcirculation. Although microcirculation is affected by surgery with CPB, monitoring of the microcirculatory function is still not part of routine practice. Continuous real-time monitoring may aid in the early detection of tissue malperfusion.
StO2 measurement using NIRS and vascular occlusion testing (VOT) are novel techniques for assessing the microcirculatory function of peripheral tissue, specifically in patients undergoing cardiac surgery with CPB. The level of StO2 is determined by the amount of oxygen delivered and consumed. The deoxygenation rate, minimum rSO2, and reoxygenation rate measured using VOT may indicate tissue perfusion, the local metabolic rate, the oxygen reserve, and microvascular reactivity. It has been shown that prolonged exposure to CPB is associated with abnormal vasomotor responses and end-organ dysfunction. Although the INVOS system is not commonly used for VOT in children undergoing cardiac surgery with CPB, we hypothesized that using this noninvasive method to measure StO2 would allow detection of the local metabolic rate and local tissue perfusion adequacy change and that StO2 changes would reflect the preexisting cardiovascular reserve.
- Conditions
- Microcirculation
- Being tested
- Near-infrared spectroscop
- Keywords
- Microcirculation, Vascular occlusion test, Near-infrared spectroscopy, Pediatric cardiopulmonary bypass, Congenital cardiac surgery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Near-infrared spectroscopDevice
Also called INVOS pediatric SomaSensor probe (Coviden, Dublin, Ireland)
Before the induction of anesthesia, INVOS pediatric SomaSensor probe (Coviden, Dublin, Ireland) was placed on the patient's forearm and then connected to a monitor, which was used to continuously measure and assess the dynamic changes in the StO2
What is being measured
The primary outcome is the main question the study is designed to answer.
Dynamic changes in the StO2
The following VOT parameters were calculated: baseline StO2 (%), occlusion slope (%/min) from baseline until nadir, minimum StO2 (%), reperfusion slope (%/min) from the minimum value to the maximum value, reperfusion time (min) from cuff release to the maximum value, and maximum StO2 (%). VOT was performed five times: before induction of anesthesia (T1), after induction of anesthesia (T2), during the CPB with full flow (T3), after the termination of the CPB (T4), and after sternum closure (T5
Measured: during operation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jan 2024
- Study start18 Jan 2021
- Primary completion6 Mar 2022
- Study completion11 Mar 2022
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 MicrocirculationStudies of the same condition, open and under way.
- 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 120 participants (actual)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Kartal Kosuyolu Yuksek Ihtisas Education and Research Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, mustafa emre gürcü, Kartal Kosuyolu Yuksek Ihtisas Education and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06191913
- Sponsor's protocol ID
- 2020/10/364
- Status last verified
- Dec 2023
- First submitted
- 20 Dec 2023
- Last updated
- 5 Jan 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Savluk OF, Yilmaz AA, Yavuz Y, Arisut S, Ukil Isildak F, Turkmen Karaagac A, Ozbek B, Cine N, Tuncer E, Ceyran H. Assessment of microcirculatory alteration by a vascular occlusion test using near-infrared spectroscopy in pediatric cardiac surgery: effect of cardiopulmonary bypass. Expert Rev Med Devices. 2024 Mar;21(3):249-255. doi: 10.1080/17434440.2024.2306155. Epub 2024 Jan 19.
PubMed 38217402
Study at a glance
From the registry record, last updated by the sponsor on 5 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Microcirculatory Alteration by a Vascular Occlusion Test Using Near-infrared Spectroscopy in Pediatric Cardiac Surgery:Effect of Cardiopulmonary Bypass
- ClinicalTrials.gov ID
- NCT06191913
- Acronym / sponsor ID
- 2020/10/364
- Conditions
- Microcirculation
- Keywords
- Microcirculation, Vascular occlusion test, Near-infrared spectroscopy, Pediatric cardiopulmonary bypass, Congenital cardiac surgery
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Kartal Kosuyolu Yuksek Ihtisas Education and Research HospitalOther government
- Study start
- 18 Jan 2021 (actual)
- Primary completion
- 6 Mar 2022 (actual)
- Study completion
- 11 Mar 2022 (actual)
- First posted
- 5 Jan 2024 (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.
Cardiopulmonary bypass cause microcirculatory alterations. Near infrared spectroscopic measurement of tissue oxygen saturation and vascular occlusion test are novel technologies for assessing the microcirculatory function of peripheral tissue specifically in patients undergoing cardiac surgery with cardiopulmonary bypass
Detailed description
Cardiac surgery and cardiopulmonary bypass (CPB) procedures cause microcirculatory alterations, and microvascular alterations and the impairment of tissue oxygen saturation (StO2) after cardiac surgery with CPB have been associated with adverse patient outcomes. It has been shown that contact with foreign surfaces causes transient microcirculatory dysfunction and activation of the inflammatory and hemostatic systems and that tissue trauma and anesthesia also affect microcirculation. Although microcirculation is affected by surgery with CPB, monitoring of the microcirculatory function is still not part of routine practice. Continuous real-time monitoring may aid in the early detection of tissue malperfusion.
StO2 measurement using NIRS and vascular occlusion testing (VOT) are novel techniques for assessing the microcirculatory function of peripheral tissue, specifically in patients undergoing cardiac surgery with CPB. The level of StO2 is determined by the amount of oxygen delivered and consumed. The deoxygenation rate, minimum rSO2, and reoxygenation rate measured using VOT may indicate tissue perfusion, the local metabolic rate, the oxygen reserve, and microvascular reactivity. It has been shown that prolonged exposure to CPB is associated with abnormal vasomotor responses and end-organ dysfunction. Although the INVOS system is not commonly used for VOT in children undergoing cardiac surgery with CPB, we hypothesized that using this noninvasive method to measure StO2 would allow detection of the local metabolic rate and local tissue perfusion adequacy change and that StO2 changes would reflect the preexisting cardiovascular reserve.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Target follow-up
- 1 Day
Who may qualify
- Ages
- 3 months to 3 years
- Sex
- All
- Age groups
- Child
- Study population
- 120 pediatric patients scheduled for elective cardiac surgery with CPB were enrolled
Key inclusion criteria (1 listed)
- Elective cardiac surgery with CPB
Key exclusion criteria (3 listed)
- Skin and peripheral vascular disease,
- Taking medicine for vascular disease,
- Emergency procedures
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 |
|---|---|---|
| Near-infrared spectroscopAlso: INVOS pediatric SomaSensor probe (Coviden, Dublin, Ireland)Before the induction of anesthesia, INVOS pediatric SomaSensor probe (Coviden, Dublin, Ireland) was placed on the patient's forearm and then connected to a monitor, which was used to continuously measure and assess the dynamic changes in the StO2 | Device | – |
Primary outcome
Dynamic changes in the StO2
Time frame: during operation
The following VOT parameters were calculated: baseline StO2 (%), occlusion slope (%/min) from baseline until nadir, minimum StO2 (%), reperfusion slope (%/min) from the minimum value to the maximum value, reperfusion time (min) from cuff release to the maximum value, and maximum StO2 (%). VOT was performed five times: before induction of anesthesia (T1), after induction of anesthesia (T2), during the CPB with full flow (T3), after the termination of the CPB (T4), and after sternum closure (T5
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 5 Jan 2024.
- Derived from this study: PubMed 38217402Savluk OF, Yilmaz AA, Yavuz Y, Arisut S, Ukil Isildak F, Turkmen Karaagac A, Ozbek B, Cine N, Tuncer E, Ceyran H. Assessment of microcirculatory alteration by a vascular occlusion test using near-infrared spectroscopy in pediatric cardiac surgery: effect of cardiopulmonary bypass. Expert Rev Med Devices. 2024 Mar;21(3):249-255. doi: 10.1080/17434440.2024.2306155. Epub 2024 Jan 19.
- 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 Microcirculation, run by Kartal Kosuyolu Yuksek Ihtisas Education and Research Hospital at 1 site in Turkey (Türkiye).
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 5 Jan 2024. 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 Turkey (Türkiye). 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?
Dynamic changes in the StO2 (time frame: during 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 NCT06191913, 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 5 Jan 2024.