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Evaluation of ResQ for Fluid Management and Respiration Monitoring in Mechanically Ventilated Patients

Efficacy and Safety of ResQ measuring Acoustic Variability Index and Respiratory Rate for Fluid Management and Respiration Monitoring in Mechanically Ventilated Patients: Prospective, Single center, Single arm, Exploratory Trial

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
CRIS
Registry ID
KCT0009380
Enrollment
40
Registered
2024-04-26
Start date
2024-02-07
Completion date
Unknown
Last updated
2024-11-14

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

Conditions

None listed

Interventions

None listed

Sponsors

Signal House
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Patients must meet all of the following inclusion criteria for this study 1) Adult at least 19 years of age 2) If female, not pregnant or lactating 3) Scheduled for surgery on a major abdominal organ (e.g., liver, pancreas, colon, bladder, uterus, etc.) 4) ASA class I or II (American Society of Anesthesiologists) - ASA class I - Healthy patients: Patients without any long-term, physiologic, or psychiatric disorders, except for infants and the elderly - ASA class II - Mild systemic disease: Patients with one systemic disease without any functional limitations (well-controlled disease: Controlled hypertension or diabetes without systemic effects, smoking without chronic obstructive pulmonary disease, mild obesity, pregnancy) 5) Patients receiving mechanical ventilation in tidal volume or pressure control mode in the operating room or intensive care unit with tidal volume 6-8 ml/kg (Ideal Body Weight, IBW), respiratory rate 8-14/min, PEEP 0-5cmH2O 6) Patients with a CV catheter, FloTrac Sensor, or Rainbow Sensor in case of intraoperative bleeding 7) Patients who understand the purpose and procedures of the study and are able to communicate clearly with the investigators and staff 8) Patients who voluntarily sign a written informed consent form before participating in this study.

Exclusion criteria

Exclusion criteria: Patients will not be eligible to participate in this study if any of the following criteria apply to them prior to surgery 1) Surgical factors - Emergency or unplanned surgery - High likelihood of reoperation or major bleeding from previous surgery for the same condition 2) Subject factors - History of severe damage to the esophagus, such as esophageal varices or strictures, making it difficult to insert a probe into the esophagus - Inability to catheterize a vein or artery to measure central venous pressure (CVP), single-volume variation (SVV), and pulse pressure variation (PVV) - Fluid loading is not feasible due to suspected pulmonary edema - BMI >30 kg/m2 - Uncontrolled preoperative coagulation disorders - Arrhythmias such as atrial fibrillation/flutter, premature atrial/ventricular contractions (>2/10 sec), and other arrhythmias that would preclude accurate cardiac output measurement9 (e.g., intracardiac shunts) - Other cardiovascular history: intracardiac shunt) - Other subjects judged by the investigator to be unsuitable for participation in this study

Design outcomes

Primary

MeasureTime frame
Acoustic Variability Index (AVI)

Secondary

MeasureTime frame
Central Venous Pressure, CVP;Stroke Volume Variation, SVV;Pulse Pressure Variation, PPV;Pleth Variability Index, PVI;Respiratory Rate, RR

Countries

Korea, Republic of

Contacts

Public ContactEunhee Kim

Asan Medical Center

92dmsgml@gmail.com+82-2-3010-3874

Outcome results

None listed

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