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Is Regional Oxygen Saturation Effective in Predicting Perfusion Parameters and Patient Outcomes in Liver Resection

NCT05077397 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2021-12-17

No results posted yet for this study

Summary

Sudden hypotension, which may develop during liver resection operations performed under general anesthesia, can affect the patient satisfaction at a high rate by causing complications during and after the operation as a result of disrupting the blood supply of the tissues. Although there are standard monitoring methods such as blood pressure, heart rate, and oxygen status that show unwanted hypotension during anesthesia, it is possible to show hypotension in the early period with new generation methods. Although there are many clinical studies proving the effectiveness of these methods, these methods have not yet been included in the standard monitoring methods.

Our prediction in this study is that the development of intraoperative and postoperative complications in patients who will undergo liver surgery, in whom tissue blood flow is monitored with the help of devices, will be less than in patients who are followed up with traditional methods.

If an individual participate in this study, he will not be subjected to any additional procedures other than routine practice during the participant's operation. Before standard general anesthesia for his surgery, heart rate, oxygenation status, blood pressure parameters will be monitored. After the initiation of general anesthesia, the procedures performed in each liver surgery will be applied. In addition, he will be followed by using a probe that allows monitoring of tissue blood flow and reflects a value to the screen, to which it is attached, by simply sticking to his skin.

Conditions

  • Tissue Injury
  • Surgery
  • Absorption; Disorder

Interventions

DEVICE

StO2

InSpectra Tissue Spectrometer Model 1615 probe (Hutchinson Technology Inc. Hutchinson, MN, USA) probes will be placed on the skin area corresponding to the patients' liver lodge prior to induction of anesthesia. In addition, the probes of both devices will be placed in the renal site on the same side. Basal values will be measured with both devices and StO2 values in the devices will be recorded every 15 minutes. Probes will not be removed during surgery and for 24 hours postoperatively.

DEVICE

O3

O3TM Regional Oximeter System (O3 System, Masimo Corporation, Irvine, CA) probes will be placed on the skin area corresponding to the patients' liver lodge prior to induction of anesthesia. In addition, the probes of both devices will be placed in the renal site on the same side. Basal values will be measured with both devices will be recorded every 15 minutes. Probes will not be removed during surgery and for 24 hours postoperatively.

Sponsors & Collaborators

  • Marmara University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-12-16
Primary Completion
2022-03-15
Completion
2022-03-20
FDA Device
Yes

Countries

  • Turkey (Türkiye)

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05077397 on ClinicalTrials.gov