Hyperoxemia and Oxygen Reserve Index During Neurointerventional Anesthesia
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorFatih Sultan Mehmet Training and Research Hospital
About this trial
The goal of this observational study is to learn how often high blood oxygen levels (hyperoxemia) occur in adults receiving general anesthesia for planned (elective) neurointerventional procedures, such as brain aneurysm coiling or other catheter-based treatments of brain vessels. It will also look at how well a non-invasive finger sensor measurement called the Oxygen Reserve Index (ORi) reflects arterial oxygen levels.
The main questions it aims to answer are:
* How often is the arterial oxygen pressure (PaO2) 150 mmHg or higher in blood gas samples taken as part of routine care during these procedures? * How does ORi relate to PaO2, and can ORi help identify high oxygen levels?
Participants will:
* Receive anesthesia and their procedure exactly as planned by their care team; the study does not change any treatment, oxygen setting, or ventilator setting. * Have a painless ORi sensor placed on a finger, similar to a standard pulse oximeter, during anesthesia. * Have their routine monitoring values and the results of arterial blood gas samples taken for routine clinical care recorded.
No extra blood samples will be taken for the study, and ORi values will not be used to guide care.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age 18 years or older
American Society of Anesthesiologists (ASA) physical status I-III
Scheduled for an elective neurointerventional procedure
Procedure performed under general anesthesia
Disqualifiers
Refusal to participate
Emergency neurointerventional procedure
ASA physical status IV or higher
Pregnancy
Trial population
Adult patients (ASA I-III) scheduled for elective neurointerventional procedures under general anesthesia with routine invasive arterial monitoring at the Interventional Radiology Unit of University of Health Sciences Fatih Sultan Mehmet Training and Research Hospital, Istanbul, Türkiye. Eligible patients will be enrolled consecutively.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Oxygen Reserve Index Monitoring (Observational)
Other interventionNon-invasive ORi measurement via multi-wavelength pulse co-oximetry, recorded blinded to the anesthesia team and not used to guide care.
Treatment groups
100 Participants
are divided into 1 treatment groupGroup A: Elective Neurointerventional Procedures Under General Anesthesia1 intervention
Trial outcomes
Primary outcomes
1
Proportion of Matched Arterial Blood Gas Measurements With PaO2 >=150 mmHg
Number of valid matched ORi-PaO2 measurement pairs with PaO2 \>=150 mmHg divided by the total number of valid matched pairs, multiplied by 100. Only arterial blood gas samples drawn for routine clinical care and matched to a valid ORi value recorded at the time of sampling or within 1 minute are included. Reported with 95% confidence interval.
Time frame
Intraoperative period, from intubation to the end of the procedure before FiO2 is increased for emergence (approximately 1-4 hours)Secondary outcomes
1
Proportion of Matched Arterial Blood Gas Measurements With PaO2 >=200 mmHg
Number of valid matched ORi-PaO2 pairs with PaO2 \>=200 mmHg divided by the total number of valid matched pairs, multiplied by 100, reported with 95% confidence interval.
Time frame
Intraoperative period, from intubation to the end of the procedure before FiO2 is increased for emergence (approximately 1-4 hours)2
Proportion of Patients With at Least One PaO2 >=150 mmHg and >=200 mmHg Measurement
Percentage of patients with at least one valid matched arterial blood gas measurement showing PaO2 \>=150 mmHg, and separately \>=200 mmHg, among patients with at least one valid matched measurement.
Time frame
Intraoperative period, from intubation to the end of the procedure before FiO2 is increased for emergence (approximately 1-4 hours)3
Per-Patient Proportion of Hyperoxemic Measurements
For each patient, the number of matched measurements with PaO2 \>=150 mmHg (and \>=200 mmHg) divided by that patient's total number of matched measurements, summarized across patients.
Time frame
Intraoperative period, from intubation to the end of the procedure before FiO2 is increased for emergence (approximately 1-4 hours)4
Perioperative Changes in ORi, SpO2, FiO2, and Hemodynamic Parameters
ORi (dimensionless, 0-1), SpO2 (%), FiO2 (%), heart rate (beats/min), mean arterial pressure (mmHg), end-tidal CO2 (mmHg), body temperature (degrees C), and perfusion index recorded at T1 (5 min after intubation), T2 (30 min), T3 (60 min), every 60 min thereafter from 120 min, and Tend (end of procedure before FiO2 increase). Changes over time analyzed with mixed-effects models.
Time frame
Intraoperative period, from intubation to the end of the procedure before FiO2 is increased for emergence (approximately 1-4 hours)Sponsors and contacts
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Source ClinicalTrials.gov
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