Oxygen Reserve Index ValuesNCT05953493
Evaluation of Oxygen Reserve Index According to Glasgow Coma Scale in Providing Oxygenation in Intracranial Surgery
An observational study of Oxygen Reserve Index Values, run by Trakya University at 1 site in Turkey (Türkiye).
Trial summary
Evaluation of oxygen reserve index according to Glasgow Coma Scale in providing oxygenation in intracranial surgery Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Oxygen Reserve Index Values
- How many people
- 150 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Mar 2022to 1 Oct 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
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 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: intracranial surgery patients
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Evaluation of oxygen reserve index according to Glasgow Coma Scale in providing oxygenation in intracranial surgery
Read the 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.
- Conditions
- Oxygen Reserve Index Values
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| GKS1 | Patients with a Glasgow coma scale between 9 and 12 | |
| GKS2 | Patients with a Glasgow coma scale between 13 and 15 |
What is being measured
The primary outcome is the main question the study is designed to answer.
ORI values
Comparison of ori values according to the glaskow coma scale
Measured: March 1, 2022-October 1, 2024
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2023
- Study start1 Mar 2022
- Primary completion1 Jun 2024 (estimated)
- Study completion1 Oct 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Oxygen Reserve Index ValuesStudies 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Trakya University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ars Gor Dr Burak Akpinar, Trakya University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05953493
- Sponsor's protocol ID
- Trakya University
- Status last verified
- Jul 2023
- First submitted
- 12 Jul 2023
- Last updated
- 20 Jul 2023
- 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 20 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Oxygen Reserve Index According to Glasgow Coma Scale in Providing Oxygenation in Intracranial Surgery
- ClinicalTrials.gov ID
- NCT05953493
- Acronym / sponsor ID
- Trakya University
- Conditions
- Oxygen Reserve Index Values
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Trakya UniversityUniversity, hospital or other
- Study start
- 1 Mar 2022 (actual)
- Primary completion
- 1 Jun 2024 (estimated)
- Study completion
- 1 Oct 2024 (estimated)
- First posted
- 20 Jul 2023 (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.
Evaluation of oxygen reserve index according to Glasgow Coma Scale in providing oxygenation in intracranial surgery
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
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| GKS1 | – | –Patients with a Glasgow coma scale between 9 and 12 |
| GKS2 | – | –Patients with a Glasgow coma scale between 13 and 15 |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- intracranial surgery patients
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (1 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
ORI values
Time frame: March 1, 2022-October 1, 2024
Comparison of ori values according to the glaskow coma scale
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jul 2023.
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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
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 Oxygen Reserve Index Values, run by Trakya University 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 1 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 20 Jul 2023. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
ORI values (time frame: March 1, 2022-October 1, 2024). 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 20 Jul 2023.