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Hemodynamic management using noninvasive oximetric sensor in cardiac surgery

NIRS-ScvO2 guided noninvasive hemodynamic management in cardiac surgery: a randomized pilot feasibility trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CRIS
Registry ID
KCT0009546
Enrollment
60
Registered
2024-06-18
Start date
2024-05-01
Completion date
Unknown
Last updated
2024-06-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Procedure/Surgery : Following induction of anesthesia, patients are monitored according to the institution's standard patient monitoring protocol, which includes transesophageal echocardiography, arte

Sponsors

Asan Medical Center
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Patients aged =19 and <80 years old. 2. Elective cardiac surgery involving cardiopulmonary bypass. 3. Individuals who have consented to participate in the study.

Exclusion criteria

Exclusion criteria: 1. Pregnancy 2. Patients with cognitive impairment or other conditions that may hinder understanding of the study content. 3. Patients unsuitable for NIRS-ScvO2 monitoring (e.g., body mass index >35 kg/m2, preoperative CT scan showing internal jugular vein depth exceeding 2 cm, preoperative CT scan showing internal jugular vein thrombosis or occlusion, internal jugular vein diameter less than 8 mm, anatomical or dermatological abnormalities at the sensor attachment site). 4. Patients with existing shunts such as arteriovenous fistulas, atrial or ventricular septal defects. 5. Patients requiring unilateral lung ventilation. 6. Patients with left bundle branch block on electrocardiogram. 7. Other conditions deemed unsuitable for the study (determined by researcher)

Design outcomes

Primary

MeasureTime frame
Informed consent acquisition rate of 40% or higher;The proportion of patients excluded due to unsuitability for NIRS-ScvO2 monitoring is less than 30%.;Success of the protocol achieved over 90% of subjects in experimental group; defined as maintaining NIRS-ScvO2 values above the threshold (80% or more of baseline) for more than 50% of the pre- and post-cardiopulmonary bypass periods.

Secondary

MeasureTime frame
Achievement rate (time) of the thresholds of primary hemodynamic parameters (SvO2 or NIRS-ScvO2) ;Time ratio with SvO2 <65%.;Time-weighted average of SvO2;Nadir of SvO2;Zenith of SvO2;Rate of ScvO2 <70%;Lactate;Other hemodynamic variables (arterial pressure, pulmonary artery pressure, central venous pressure, cardiac output);Vasopressor Inotropic Score;Fluid intake;Amount of transfusion;Mortality (death within the hospitalization period or within 30 days of surgery);Type 5 myocardial infarction;Atrial fibrillation;Stroke;Delirium;Acute kidney injury;Hemodialysis;Mechanical circulatory support;Delayed extubation or re-intubation;Length of ICU stay;Length of hospital stay

Countries

Korea, Republic of

Contacts

Public ContactJaesik Nam

Asan Medical Center

jaesik_nam@naver.com+82-2-3010-3868

Outcome results

None listed

Source: CRIS (via WHO ICTRP) · Data processed: Feb 4, 2026