Comparison of the Effects of High, Low and Minimal Flow Anesthesia Managements on ORI and Partial Oxygen Pressure

NCT05329233 | Completed

• 1 other identifier: KAEK-2020/1/1
• Study Type: observational
• Target: 90
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of our study is to show that continuous oxygen reserve index monitoring is a non-invasive monitoring method that can be used as a supporting parameter to PaO2 in blood gas in hypoxia and hyperoxia monitoring when different fresh gas flow is used in general anesthesia.

Conditions

General Anesthetic

Keywords

low flow anesthesia; oxygen reserve index; arterial oxygen pressure

Outcome Measures

Primary Outcomes (1)

• The use of continuous ORI monitoring as a supporting parameter to PaO2 in blood gasses during hypoxia and hyperoxia

  To show that continuous ORI monitoring is non-invasive monitoring that can be used as a supporting parameter for PaO2 in blood gas in hypoxia and hyperoxia monitoring when different fresh gas flows (4, 1, 0.5 L/min) are used in general anesthesia practice.

  intraoperative period

Secondary Outcomes (1)

• The use of continuous ORI monitoring as a supporting parameter to PaO2 in blood gasses during hypoxia and hyperoxia

  İntraoperative period

Study Arms (3)

minimal flow

For minimal-flow anesthesia, oxygen 0.3 L/min and medical air 0.2 L/min (FGF 0.5 L/min, FiO2 68%) were administered to patients in group M.

Device: Masimo Radical-7 Pulse CO-Oximeter

low flow

For low-flow anesthesia, oxygen 0.37 L/min and medical air 0.63 L/min (FGF 1 L/min, FiO2 50%) were administered to patients in group L.

Device: Masimo Radical-7 Pulse CO-Oximeter

high flow

For high-flow anesthesia, oxygen 1 L/min and medical air 3 L/min (FGF 4 L/min, FiO2 40%) were administered to patients in group H.

Device: Masimo Radical-7 Pulse CO-Oximeter

Interventions

Masimo Radical-7 Pulse CO-Oximeter DEVICE

The Masimo Radical-7 Pulse CO-Oximeter is a device for the measurement of pulse oximetry, oxygen reserve index (ORi), perfusion index (PI), and pleth variability index (PVI). The device is the product of a company called Masimo Inc, Irvine, CA, USA

high flow; low flow; minimal flow

Eligibility Criteria

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

Study Population

ASA II and III patients aged between 18-75 years, who were scheduled to undergo elective open abdominal surgery lasting \<60 minutes under general anesthesia

You may qualify if:

• ASA II and III patients,
• Aged between 18-75 years,
• who were scheduled to undergo elective open abdominal surgery lasting \<60 minutes under general anesthesia

You may not qualify if:

• inability to use the sensor due to finger deformation or hypoperfusion,
• having a history of malignant hyperthermia,
• presence of clinically significant anemia, morbid obesity, alcohol or drug addiction, having a severe cardiac, renal or hepatic impairment,
• having a history of cerebrovascular disease,
• being a pregnant or presently lactating and having local anesthetic or opioid sensitivity

Sponsors & Collaborators

• Samsun Education and Research Hospital: lead

Study Sites (1)

Samsun Research and Education Hospital

Samsun, 55090, Turkey (Türkiye)

Location

Related Publications (3)

• Baxter AD. Low and minimal flow inhalational anaesthesia. Can J Anaesth. 1997 Jun;44(6):643-52; quiz 652-3. doi: 10.1007/BF03015449.

  PMID: 9187785 RESULT

• Vos JJ, Willems CH, van Amsterdam K, van den Berg JP, Spanjersberg R, Struys MMRF, Scheeren TWL. Oxygen Reserve Index: Validation of a New Variable. Anesth Analg. 2019 Aug;129(2):409-415. doi: 10.1213/ANE.0000000000003706.

  PMID: 30138170 RESULT

• Scheeren TWL, Belda FJ, Perel A. The oxygen reserve index (ORI): a new tool to monitor oxygen therapy. J Clin Monit Comput. 2018 Jun;32(3):379-389. doi: 10.1007/s10877-017-0049-4. Epub 2017 Aug 8.

  PMID: 28791567 RESULT

Study Officials

• Zahide Doganay, Professor

  Samsun Research and Education Hospital

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Day
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Anesthesiologist

Study Record Dates

• First Submitted: April 7, 2022
• First Posted: April 14, 2022
• Study Start: January 1, 2020
• Primary Completion: June 1, 2020
• Study Completion: September 1, 2020
• Last Updated: April 22, 2022

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: The data will be available after the publication of our data upon request from the researchers.
• Access Criteria: There is no internet website to obtain data but the researchers can contact Dr. Naci Murat, Ondokuz Mayis University, Samsun, Turkey.

Locations

TU (1)