Microcirculatory Alteration by a Vascular Occlusion Test Using Near-infrared Spectroscopy in Pediatric Cardiac Surgery
Assessment of Microcirculatory Alteration by a Vascular Occlusion Test Using Near-infrared Spectroscopy in Pediatric Cardiac Surgery:Effect of Cardiopulmonary Bypass
1 other identifier
observational
120
1 country
1
Brief 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 bypass
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Jan 2021
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 18, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 6, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
March 11, 2022
CompletedFirst Submitted
Initial submission to the registry
December 20, 2023
CompletedFirst Posted
Study publicly available on registry
January 5, 2024
CompletedJanuary 5, 2024
December 1, 2023
1.1 years
December 20, 2023
December 20, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
during operation
Interventions
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
Eligibility Criteria
120 pediatric patients scheduled for elective cardiac surgery with CPB were enrolled
You may qualify if:
- Elective cardiac surgery with CPB
You may not qualify if:
- Skin and peripheral vascular disease,
- Taking medicine for vascular disease,
- Emergency procedures
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Mustafa Emre Gurcu
Istanbul, 34865, Turkey (Türkiye)
Related Publications (1)
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.
PMID: 38217402DERIVED
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- PROSPECTIVE
- Target Duration
- 1 Day
- Sponsor Type
- OTHER GOV
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Anesthesiology and reanimation
Study Record Dates
First Submitted
December 20, 2023
First Posted
January 5, 2024
Study Start
January 18, 2021
Primary Completion
March 6, 2022
Study Completion
March 11, 2022
Last Updated
January 5, 2024
Record last verified: 2023-12
Data Sharing
- IPD Sharing
- Will not share