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Evaluation of Oxygen Reserve Index According to Glasgow Coma Scale in Providing Oxygenation in Intracranial Surgery

Sponsor
Trakya University (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT05953493
Collaborator
(none)
150
Enrollment
1
Location
31
Anticipated Duration (Months)
4.8
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Evaluation of oxygen reserve index according to Glasgow Coma Scale in providing oxygenation in intracranial surgery

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    Peroperative oxygenation is one of the most important parameters in providing cerebral blood flow in intracranial surgeries. SpO2, which is included in standard monitoring, is used to show perioperative hypoxia. Although blood gas analysis used in the evaluation of hypoxia is the gold standard for measurement of oxygenation, it is invasive and impractical. For these reasons, oxygen reserve index (ORI) monitoring, which can detect hypoxia earlier than Spo2 measurement and does not require invasive procedures, is a valuable parameter. Patients with different Glasgow Coma Scale (GCS) values may also have different susceptibility to hypoxia. This study aims to evaluate the effectiveness of ORI monitoring in detecting hypoxia and its correlation with SPO2 in providing oxygenation in patients with different GCS values in intracranial surgery.

    Method: 150 patients in the ASA I-II-III risk group between the ages of 18-80 who will undergo intracranial surgery by Brain and Nerve Surgery at Trakya University Medical Faculty Hospital will be included in the study. Patients who cannot insert a sensor due to finger deformity or hypoperfusion, intubation difficulty, who have cardiac or pulmonary disease, and preoperative anemia due to hemoglobinopathies will be excluded from the study. When the patients are taken to the operating table, they will be monitored and the input values will be recorded, and they will be divided into two different patient groups as GCS values (9-12) and (13-15). During intracranial surgery; ORI, blood gas, and SPO2 measurements will be recorded during baseline, induction, intubation, pin application, skin incision, craniotomy, dural opening, aneurysm clipping, bleeding control, pin removal, and skin closure. All hemodynamic parameters of the patients such as blood pressure, heart rate, SpO2, ORI, BIS (Bispectral index) values, oxygen saturation, Et CO2, SpO2;% during anesthesia, operation type, operation time, amounts of used anesthetic and analgesic agents, from anesthesia document, will be saved from files and monitors. Postoperative recovery scores (Modified Alderate scoring), VAS values on the first day (1, 2, 4, 6, 12, 24 hours) and analgesics used, time of first postoperative analgesia use and developing complications will be recorded.

    Statistics: The suitability of the data to the normal distribution will be examined with the one-sample Kolmogorov Smirnov Test. Student's t-test will be used to compare the quantitative values with normal distribution between the groups, and the Mann-Whitney U test will be used to compare those that do not show normal distribution.

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    150 participants
    Observational Model:
    Case-Control
    Time Perspective:
    Prospective
    Official Title:
    Evaluation of Oxygen Reserve Index According to Glasgow Coma Scale in Providing Oxygenation in Intracranial Surgery
    Actual Study Start Date :
    Mar 1, 2022
    Anticipated Primary Completion Date :
    Jun 1, 2024
    Anticipated Study Completion Date :
    Oct 1, 2024

    Arms and Interventions

    Arm Intervention/Treatment
    GKS1

    Patients with a Glasgow coma scale between 9 and 12
    GKS2

    Patients with a Glasgow coma scale between 13 and 15

    Outcome Measures

    Primary Outcome Measures

    1. ORI values [March 1, 2022-October 1, 2024]

      Comparison of ori values according to the glaskow coma scale

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 80 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:
    • 150 patients in the ASA I-II-III risk group between the ages of 18-80 who will undergo intracranial surgery by Brain and Nerve Surgery at Trakya University Medical Faculty Hospital will be included in the study
    Exclusion Criteria:
    • Patients who cannot insert a sensor due to finger deformity or hypoperfusion, intubation difficulty, who have cardiac or pulmonary disease, and preoperative anemia due to hemoglobinopathies will be excluded from the study

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Trakya Universiy Edirne Turkey

    Sponsors and Collaborators

    • Trakya University

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Ars Gor Dr Burak Akpinar, Research Assistant Doctor, Trakya University
    ClinicalTrials.gov Identifier:
    NCT05953493
    Other Study ID Numbers:
    • Trakya University
    First Posted:
    Jul 20, 2023
    Last Update Posted:
    Jul 20, 2023
    Last Verified:
    Jul 1, 2023
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No

    Study Results

    No Results Posted as of Jul 20, 2023