Microcirculatory Alteration by a Vascular Occlusion Test Using Near-infrared Spectroscopy in Pediatric Cardiac Surgery

NCT ID: NCT06191913

Last Updated: 2024-01-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

120 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-01-18

Study Completion Date

2022-03-11

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

See the medical conditions and disease areas that this research is targeting or investigating.

Microcirculation

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Near-infrared spectroscop

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

Intervention Type DEVICE

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

INVOS pediatric SomaSensor probe (Coviden, Dublin, Ireland)

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

Elective cardiac surgery with CPB

Exclusion Criteria

* Skin and peripheral vascular disease,
* Taking medicine for vascular disease,
* Emergency procedures
Minimum Eligible Age

3 Months

Maximum Eligible Age

3 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Kartal Kosuyolu Yuksek Ihtisas Education and Research Hospital

OTHER_GOV

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

mustafa emre gürcü

Anesthesiology and reanimation

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Mustafa Emre Gurcu

Istanbul, , Turkey (Türkiye)

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Turkey (Türkiye)

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type DERIVED
PMID: 38217402 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

2020/10/364

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.