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

NCT05077397 | Unknown FDA Device

• 1 other identifier: 2021.03.17
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

liver; tissue oxygenation; near infrared spectroscopy; resection

Outcome Measures

Primary Outcomes (3)

• Hepatic and renal tissue oxygenation

  we will evaluate the effects of hepatic and renal StO2 measurement on early hypoperfusion and postoperative survival in hepatectomy cases, and peripheral tissue oxygen saturation measurement with StO2 InSpectra Tissue Spectrometer Model 1615 probe (Hutchinson Technology Inc. Hutchinson, MN, USA) and O3TM Regional Oximeter System ( We aimed to observe by doing it with O3 System, Masimo Corporation, Irvine, CA) devices.

  baseline STO2 and O3 measurements at the beginning of the operation

• Hepatic and renal tissue oxygenation

  we will evaluate the effects of hepatic and renal StO2 measurement on early hypoperfusion and postoperative survival in hepatectomy cases, and peripheral tissue oxygen saturation measurement with StO2 InSpectra Tissue Spectrometer Model 1615 probe (Hutchinson Technology Inc. Hutchinson, MN, USA) and O3TM Regional Oximeter System ( We aimed to observe by doing it with O3 System, Masimo Corporation, Irvine, CA) devices.

  STO2 and O3 measurements at the end of the operation

• Hepatic and renal tissue oxygenation

  we will evaluate the effects of hepatic and renal StO2 measurement on early hypoperfusion and postoperative survival in hepatectomy cases, and peripheral tissue oxygen saturation measurement with StO2 InSpectra Tissue Spectrometer Model 1615 probe (Hutchinson Technology Inc. Hutchinson, MN, USA) and O3TM Regional Oximeter System ( We aimed to observe by doing it with O3 System, Masimo Corporation, Irvine, CA) devices.

  STO2 and O3 measurements at 24th hour postoperatively

Secondary Outcomes (3)

• age

  at 24th hour postoperatively

• ASA status

  at 24th hour postoperatively

• Vascular clamp duration

  İntraoperative duration of vascular clamp (minute)

Study Arms (3)

Group 1

ACTIVE COMPARATOR

After the approval of the local ethics committee and written informed consent, 60 ASA I-III patients aged 18-75 years who will undergo liver resection will be included in the study. Patients of Group 1 will be monitored by the InSpectra Tissue Spectrometer, StO2, added to standard ASA monitorisation.

Device: StO2

Group 2

ACTIVE COMPARATOR

After the approval of the local ethics committee and written informed consent, 60 ASA I-III patients aged 18-75 years who will undergo liver resection will be included in the study. Patients of Group 2 will be monitored by O3TM Regional Oximeter System, added to standard ASA monitorisation.

Device: O3

Group 3

NO INTERVENTION

After the approval of the local ethics committee and written informed consent, 60 ASA I-III patients aged 18-75 years who will undergo liver resection will be included in the study. Patients of Group 2 will be monitored by standard ASA monitorisation.

Interventions

StO2 DEVICE

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.

Group 1

O3 DEVICE

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.

Group 2

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \- patients with ASA I-III physical status
• patients between the ages of 18-75
• patients who will undergo liver resection

You may not qualify if:

• \- patients with ASA physical status of IV
• patients with clinically significant cardiovascular, respiratory, renal or metabolic disease, ischemic cerebrovascular disease
• Patients who have BMI \>30
• Patients who aged \>75 years
• Patients with intellectual disability
• Patients who will have intraoperative surgical complications
• Patients who will need for postoperative ventilation
• Patients who have methemoglobinemia after intravascular dye injection

Sponsors & Collaborators

• Marmara University: lead

Study Sites (1)

Marmara University

Istanbul, Turkey (Türkiye)

RECRUITING

Related Publications (2)

• Brazy JE, Lewis DV, Mitnick MH, Jobsis vander Vliet FF. Noninvasive monitoring of cerebral oxygenation in preterm infants: preliminary observations. Pediatrics. 1985 Feb;75(2):217-25.

  PMID: 2982128 BACKGROUND

• Nardi O, Zavala E, Martin C, Nanas S, Scheeren T, Polito A, Borrat X, Annane D. Targeting skeletal muscle tissue oxygenation (StO2) in adults with severe sepsis and septic shock: a randomised controlled trial (OTO-StS Study). BMJ Open. 2018 Mar 19;8(3):e017581. doi: 10.1136/bmjopen-2017-017581.

  PMID: 29555789 BACKGROUND

Central Study Contacts

Gul Cakmak, MD

CONTACT

+905074694100; drgulcakmak@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: September 12, 2021
• First Posted: October 14, 2021
• Study Start: December 16, 2021
• Primary Completion: March 15, 2022
• Study Completion: March 20, 2022
• Last Updated: December 17, 2021

Record last verified: 2021-12

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)