HyperoxiaNCT07859982
Hyperoxemia and Oxygen Reserve Index During Neurointerventional Anesthesia
An observational study of Hyperoxia and Hyperoxemia, run by Fatih Sultan Mehmet Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hyperoxia, Hyperoxemia, Cerebrovascular Disorders
- What is being tested?
- Oxygen Reserve Index Monitoring (Observational)
- How many people
- 100 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- Oct 2026to Apr 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study 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.
Who may be able to join
- 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
- Invasive arterial pressure monitoring and arterial blood gas sampling planned as part of routine clinical care
- Written informed consent obtained from the patient or, when required, the legal representative
Who cannot join
- Refusal to participate
- Emergency neurointerventional procedure
- ASA physical status IV or higher
- Pregnancy
- Mechanical ventilation before the procedure
- Chronic respiratory failure requiring long-term home oxygen therapy
- Severe peripheral circulatory impairment or technical signal failure preventing reliable ORi measurement
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site
University of Health Sciences Fatih Sultan Mehmet Training and Research Hospital Scientific Research
Istanbul, 34000
Cansu Ofluoglu, MD, +905358640564, cansuakin.iu@gmail.com
About this study
Official title: Arterial Hyperoxemia and Oxygen Reserve Index During Elective Neurointerventional Procedures Under General Anesthesia: A Prospective Observational Study
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:
Read more
- 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.
Read the detailed description
Background and rationale:
Oxygen is routinely given during general anesthesia to prevent hypoxemia. However, oxygen given beyond the patient's needs may cause arterial hyperoxemia, which has been linked to vasoconstriction, oxidative stress, and absorption atelectasis. Normobaric hyperoxia has been shown to reduce cerebral blood flow, and cumulative hyperoxemia exposure has been associated with unfavorable outcomes in ventilated patients with aneurysmal subarachnoid hemorrhage. Although these findings come from critically ill populations, they provide a physiological rationale for describing arterial oxygen levels in patients undergoing elective neurointerventional procedures, in whom maintaining cerebral perfusion is essential.
Standard pulse oximetry (SpO2) plateaus at high arterial oxygen levels and cannot detect hyperoxemia. The Oxygen Reserve Index (ORi) is a continuous, non-invasive, dimensionless index (0 to 1) derived from multi-wavelength pulse co-oximetry, reported to reflect oxygenation changes in the moderately hyperoxic range (approximately PaO2 100-200 mmHg). The ORi-PaO2 relationship varies across populations and clinical settings, and it has not been described in stable adults undergoing elective neurointerventional procedures under general anesthesia.
Study design:
This is a single-center, prospective, observational study conducted at the Department of Anesthesiology and Reanimation and the Interventional Radiology Unit of University of Health Sciences Fatih Sultan Mehmet Training and Research Hospital, Istanbul, Türkiye. No randomization, group allocation, or clinical intervention will be performed.
Procedures:
Anesthesia induction and maintenance, ventilator settings, FiO2, fluids, vasoactive drugs, and all other management will follow the attending anesthesiologist's routine practice. In addition to standard monitoring, an ORi-capable pulse co-oximetry sensor will be applied. ORi values will be recorded by the investigator but will not be used for clinical decision-making, and no changes in FiO2, ventilation, or treatment will be made based on ORi.
ORi, SpO2, FiO2, heart rate, mean arterial pressure, end-tidal carbon dioxide, body temperature, perfusion index, and signal quality will be recorded at the following time points: 5 minutes after intubation and initiation of mechanical ventilation (T1), 30 minutes (T2) and 60 minutes (T3) after the start of the procedure, every 60 minutes thereafter starting at 120 minutes if the procedure continues (T4 onward), and at the end of the procedure before FiO2 is increased for emergence (Tend).
Whenever an arterial blood gas sample is drawn by the clinical team for routine care, PaO2, PaCO2, pH, SaO2, hemoglobin, and lactate will be recorded and matched with ORi, SpO2, FiO2, perfusion index, and hemodynamic values recorded at the time of sampling or within 1 minute. No additional blood samples will be drawn for research purposes, and the timing and number of routine samples will not be altered.
Patients without a routine arterial blood gas will remain in the cohort for descriptive analyses; PaO2-based analyses will include all valid matched ORi-PaO2 pairs.
Sample size and statistical analysis:
Assuming an expected hyperoxemia proportion of 50%, a 95% confidence level, and a precision of +/-10%, the minimum required sample size is 96 patients; 100 patients will be enrolled to account for missing data. The proportion of matched measurements with PaO2 >=150 mmHg will be reported with 95% confidence intervals. Repeated measurements will be analyzed with mixed-effects models. The ORi-PaO2 relationship, including possible nonlinearity and plateau behavior, will be evaluated with appropriate regression models. The ability of ORi to discriminate PaO2 >=150 and >=200 mmHg will be explored with ROC analysis, accounting for within-patient clustering. A p value <0.05 will be considered statistically significant.
Data protection:
All data will be de-identified, recorded on study case report forms, and used by the study team for scientific purposes only.
- Being tested
- Oxygen Reserve Index Monitoring (Observational)
- Keywords
- oxygen Reserve Index, ORİ, Arterial Blood Gas, PaO2, Pulse Co-oximetry, Neurointerventional Procedures, Endovascular Procedures, General Anesthesia, Oxygen Therapy, Fraction of Inspired Oxygen
- Medical subject headings
- Hyperoxia, Cerebrovascular Disorders, Intracranial Aneurysm
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oxygen Reserve Index Monitoring (Observational)Other
Non-invasive ORi measurement via multi-wavelength pulse co-oximetry, recorded blinded to the anesthesia team and not used to guide care.
| Study group | Role | What they receive |
|---|---|---|
| Elective Neurointerventional Procedures Under General Anesthesia | Adult patients (ASA I-III) undergoing elective neurointerventional procedures under general anesthesia with routine invasive arterial pressure monitoring. All anesthetic, ventilatory, and oxygen management follows routine clinical practice. An ORi-capable pulse co-oximetry sensor is applied for observational recording only; ORi values are not used for clinical decisions. Routine monitoring data and results of arterial blood gas samples drawn for clinical care are recorded. No additional blood samples are taken for research purposes. Receives: Other: Oxygen Reserve Index Monitoring (Observational) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Intraoperative period, from intubation to the end of the procedure before FiO2 is increased for emergence (approximately 1-4 hours)
Secondary outcomes (7)
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.
Measured: Intraoperative period, from intubation to the end of the procedure before FiO2 is increased for emergence (approximately 1-4 hours)
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.
Measured: Intraoperative period, from intubation to the end of the procedure before FiO2 is increased for emergence (approximately 1-4 hours)
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.
Measured: Intraoperative period, from intubation to the end of the procedure before FiO2 is increased for emergence (approximately 1-4 hours)
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.
Measured: Intraoperative period, from intubation to the end of the procedure before FiO2 is increased for emergence (approximately 1-4 hours)
Relationship Between ORi and PaO2
Association between ORi and PaO2 in matched measurement pairs, evaluated with linear and nonlinear regression models accounting for repeated measurements within patients, including assessment of a possible plateau in ORi at higher PaO2 values.
Measured: Intraoperative period, from intubation to the end of the procedure before FiO2 is increased for emergence (approximately 1-4 hours)
Discriminative Ability of ORi for PaO2 >=150 mmHg and >=200 mmHg
Area under the receiver operating characteristic curve (AUROC) of ORi for detecting PaO2 >=150 mmHg and >=200 mmHg in matched pairs, with optimal cut-off, sensitivity, and specificity. Exploratory analysis accounting for within-patient clustering.
Measured: Intraoperative period, from intubation to the end of the procedure before FiO2 is increased for emergence (approximately 1-4 hours)
Factors Associated With Hyperoxemia
Association of hyperoxemia (PaO2 >=150 mmHg) with patient characteristics (age, sex, body mass index, ASA class, comorbidities), anesthesia characteristics (FiO2, anesthesia duration), and procedure characteristics (procedure type, duration, contrast volume), evaluated with multivariable mixed-effects models.
Measured: Intraoperative period, from intubation to the end of the procedure before FiO2 is increased for emergence (approximately 1-4 hours)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Oct 2026
- Study startOct 2026 (estimated)
- Primary completionApr 2027 (estimated)
- Study completionApr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HyperoxiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fatih Sultan Mehmet Training and Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Cansu Ofluoğlu, Fatih Sultan Mehmet Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07859982
- Sponsor's protocol ID
- FSM-ORİ-ANGİO-2026
- Other IDs
- 2026/09-80
- Status last verified
- Sep 2026
- First submitted
- 30 Sep 2026
- Last updated
- 6 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Arterial Hyperoxemia and Oxygen Reserve Index During Elective Neurointerventional Procedures Under General Anesthesia: A Prospective Observational Study
- ClinicalTrials.gov ID
- NCT07859982
- Acronym / sponsor ID
- FSM-ORİ-ANGİO-2026
- Keywords
- oxygen Reserve Index, ORİ, Arterial Blood Gas, PaO2, Pulse Co-oximetry, Neurointerventional Procedures, Endovascular Procedures, General Anesthesia
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Fatih Sultan Mehmet Training and Research HospitalUniversity, hospital or other
- Study start
- Oct 2026 (estimated)
- Primary completion
- Apr 2027 (estimated)
- Study completion
- Apr 2027 (estimated)
- First posted
- 6 Oct 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Background and rationale:
Oxygen is routinely given during general anesthesia to prevent hypoxemia. However, oxygen given beyond the patient's needs may cause arterial hyperoxemia, which has been linked to vasoconstriction, oxidative stress, and absorption atelectasis. Normobaric hyperoxia has been shown to reduce cerebral blood flow, and cumulative hyperoxemia exposure has been associated with unfavorable outcomes in ventilated patients with aneurysmal subarachnoid hemorrhage. Although these findings come from critically ill populations, they provide a physiological rationale for describing arterial oxygen levels in patients undergoing elective neurointerventional procedures, in whom maintaining cerebral perfusion is essential.
Standard pulse oximetry (SpO2) plateaus at high arterial oxygen levels and cannot detect hyperoxemia. The Oxygen Reserve Index (ORi) is a continuous, non-invasive, dimensionless index (0 to 1) derived from multi-wavelength pulse co-oximetry, reported to reflect oxygenation changes in the moderately hyperoxic range (approximately PaO2 100-200 mmHg). The ORi-PaO2 relationship varies across populations and clinical settings, and it has not been described in stable adults undergoing elective neurointerventional procedures under general anesthesia.
Study design:
This is a single-center, prospective, observational study conducted at the Department of Anesthesiology and Reanimation and the Interventional Radiology Unit of University of Health Sciences Fatih Sultan Mehmet Training and Research Hospital, Istanbul, Türkiye. No randomization, group allocation, or clinical intervention will be performed.
Procedures:
Anesthesia induction and maintenance, ventilator settings, FiO2, fluids, vasoactive drugs, and all other management will follow the attending anesthesiologist's routine practice. In addition to standard monitoring, an ORi-capable pulse co-oximetry sensor will be applied. ORi values will be recorded by the investigator but will not be used for clinical decision-making, and no changes in FiO2, ventilation, or treatment will be made based on ORi.
ORi, SpO2, FiO2, heart rate, mean arterial pressure, end-tidal carbon dioxide, body temperature, perfusion index, and signal quality will be recorded at the following time points: 5 minutes after intubation and initiation of mechanical ventilation (T1), 30 minutes (T2) and 60 minutes (T3) after the start of the procedure, every 60 minutes thereafter starting at 120 minutes if the procedure continues (T4 onward), and at the end of the procedure before FiO2 is increased for emergence (Tend).
Whenever an arterial blood gas sample is drawn by the clinical team for routine care, PaO2, PaCO2, pH, SaO2, hemoglobin, and lactate will be recorded and matched with ORi, SpO2, FiO2, perfusion index, and hemodynamic values recorded at the time of sampling or within 1 minute. No additional blood samples will be drawn for research purposes, and the timing and number of routine samples will not be altered.
Patients without a routine arterial blood gas will remain in the cohort for descriptive analyses; PaO2-based analyses will include all valid matched ORi-PaO2 pairs.
Sample size and statistical analysis:
Assuming an expected hyperoxemia proportion of 50%, a 95% confidence level, and a precision of +/-10%, the minimum required sample size is 96 patients; 100 patients will be enrolled to account for missing data. The proportion of matched measurements with PaO2 >=150 mmHg will be reported with 95% confidence intervals. Repeated measurements will be analyzed with mixed-effects models. The ORi-PaO2 relationship, including possible nonlinearity and plateau behavior, will be evaluated with appropriate regression models. The ability of ORi to discriminate PaO2 >=150 and >=200 mmHg will be explored with ROC analysis, accounting for within-patient clustering. A p value <0.05 will be considered statistically significant.
Data protection:
All data will be de-identified, recorded on study case report forms, and used by the study team for scientific purposes only.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Elective Neurointerventional Procedures Under General Anesthesia | – | Other: Oxygen Reserve Index Monitoring (Observational)Adult patients (ASA I-III) undergoing elective neurointerventional procedures under general anesthesia with routine invasive arterial pressure monitoring. All anesthetic, ventilatory, and oxygen management follows routine clinical practice. An ORi-capable pulse co-oximetry sensor is applied for observational recording only; ORi values are not used for clinical decisions. Routine monitoring data and results of arterial blood gas samples drawn for clinical care are recorded. No additional blood samples are taken for research purposes. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study 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.
Key inclusion criteria (6 listed)
- 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
- Invasive arterial pressure monitoring and arterial blood gas sampling planned as part of routine clinical care
Key exclusion criteria (7 listed)
- Refusal to participate
- Emergency neurointerventional procedure
- ASA physical status IV or higher
- Pregnancy
- Mechanical ventilation before the procedure
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Oxygen Reserve Index Monitoring (Observational)Non-invasive ORi measurement via multi-wavelength pulse co-oximetry, recorded blinded to the anesthesia team and not used to guide care. | Other | Elective Neurointerventional Procedures Under General Anesthesia |
Primary outcome
Proportion of Matched Arterial Blood Gas Measurements With PaO2 >=150 mmHg
Time frame: Intraoperative period, from intubation to the end of the procedure before FiO2 is increased for emergence (approximately 1-4 hours)
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.
7 secondary outcomes
Proportion of Matched Arterial Blood Gas Measurements With PaO2 >=200 mmHg
Time frame: Intraoperative period, from intubation to the end of the procedure before FiO2 is increased for emergence (approximately 1-4 hours)
Proportion of Patients With at Least One PaO2 >=150 mmHg and >=200 mmHg Measurement
Time frame: Intraoperative period, from intubation to the end of the procedure before FiO2 is increased for emergence (approximately 1-4 hours)
Per-Patient Proportion of Hyperoxemic Measurements
Time frame: Intraoperative period, from intubation to the end of the procedure before FiO2 is increased for emergence (approximately 1-4 hours)
Perioperative Changes in ORi, SpO2, FiO2, and Hemodynamic Parameters
Time frame: Intraoperative period, from intubation to the end of the procedure before FiO2 is increased for emergence (approximately 1-4 hours)
Relationship Between ORi and PaO2
Time frame: Intraoperative period, from intubation to the end of the procedure before FiO2 is increased for emergence (approximately 1-4 hours)
Discriminative Ability of ORi for PaO2 >=150 mmHg and >=200 mmHg
Time frame: Intraoperative period, from intubation to the end of the procedure before FiO2 is increased for emergence (approximately 1-4 hours)
Factors Associated With Hyperoxemia
Time frame: Intraoperative period, from intubation to the end of the procedure before FiO2 is increased for emergence (approximately 1-4 hours)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Oct 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hyperoxia and Hyperoxemia, run by Fatih Sultan Mehmet Training and Research Hospital at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 6 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Cansu Ofluoglu, MD (+905358640564, cansuakin.iu@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of Matched Arterial Blood Gas Measurements With PaO2 >=150 mmHg (time frame: Intraoperative period, from intubation to the end of the procedure before FiO2 is increased for emergence (approximately 1-4 hours)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Oct 2026; AzTrials last refreshed its copy on 26 Oct 2026.