HyperoxiaNCT06326372
The Effect of Intraoperative Hyperoxemia on Postoperative Delirium in Geriatric Patients
An observational study of Hyperoxia and Delirium in Old Age, run by Tepecik Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
Oxygen therapy is the most common treatment modality for patients with hypoxemia, but target values for normoxemia are not clearly defined. Therefore, iatrogenic hyperoxemia is a very common situation. Read more about this study
- Who is it for?
- Ages 65 years and olderHealthy volunteers can take part
- Conditions the study is for
- Hyperoxia, Delirium in Old Age
- What is being tested?
- ORi+SpO2
- Type of treatment
- Surgery or procedure
- How many people
- 114 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Oct 2023to 7 Jul 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 65 years and older
- All sexes
- Healthy volunteers accepted
- Older adult
Study population: Patients aged 65 and older. Geriatric patients
Who may be able to join
- Patients aged 65 and older
- Patients expected to have surgery lasting more than 2 hours
- Patients with ASA (American Society of Anesthesiologists) classification 1-2-3-4
- Patients planned to have at least 2 days of postoperative hospitalization
Who cannot join
- Patients with preoperative central nervous system disorders or dementia
- Patients with MMSE (Mini-Mental State Examination) scores of 23 or below
- Patients unable to communicate
- Emergency surgeries
- Patients who refuse to participate in the study
- Patients using high-dose vasopressors
- Patients with peripheral hypoperfusion
- Hemodynamically unstable patients
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Intraoperative Hyperoxemia on Postoperative Delirium in Geriatric Patients and the Preventive Role of Oxygen Reserve Index"
Oxygen therapy is the most common treatment modality for patients with hypoxemia, but target values for normoxemia are not clearly defined. Therefore, iatrogenic hyperoxemia is a very common situation. Even though there are many side effects reported related to hyperoxemia and hyperoxemia is shown to be related to worse outcome than expected; clinicians still observe hyperoxemia frequently.
Oxygen reserve index (ORi™) (Masimo Corp., Irvine, USA) can guide clinicians in detection of hyperoxia. ORi is a parameter which can evaluate partial pressure of oxygen (PaO2) rating from 0 to 1. There are growing evidences in ORi that it might be helpful to reduce hyperoxia in general anesthesia. Continuous ORi monitoring can be used for detecting and preventing hyperoxia. The ability to perform FiO2 titration with ORi may be an appropriate monitoring management to prevent the harmful effects of hyperoxia.In this study, in patients who underwent major abdominal surgery; It was aimed to investigate the effectiveness of ORi-guided FiO2 titration in preventing hyperoxia.
Read the detailed description
The definition of elderly by the World Health Organization is individuals aged 65 and older. As the average life expectancy continues to increase, the number of surgical procedures performed in the geriatric population is also increasing.
Postoperative delirium is a complication that occurs after surgery and is characterized by sudden-onset confusion, fluctuating mental status, and attention deficits. Its incidence increases in elderly patients and is higher in those with pre-existing mild cognitive impairment. The etiology encompasses multiple factors such as age, presence of additional comorbidities, metabolic disorders, hypoxia, polypharmacy, pain, hypothermia, and may be associated with the depth of anesthesia during surgery.
Early recognition and prevention of delirium will become more prominent in the future due to reduced hospitalization durations, postoperative complications, and mortality rates.
Various methods are available to detect hyperoxemia during surgery. Hyperoxemia can be detected using noninvasive finger pulse oximetry with the oxygen reserve index parameter. Oxygen levels can be noninvasively assessed during operations using routine oxygen saturation and oxygen reserve index measurements.
Delirium can be evaluated in both intensive care and ward patients. The gold standard for diagnosis is the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) criteria. DSM-5 criteria require psychiatric evaluation and are conducted by someone with psychiatric training. Additionally, the Confusion Assessment Method (CAM) is used for diagnosis and can be evaluated as CAM-ICU for intubated patients in intensive care units.
- Conditions
- Hyperoxia, Delirium in Old Age
- Being tested
- control, ORi+SpO2
- Medical subject headings
- Hyperoxia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
controlProcedure or surgery
Fraction of inspired oxygen (FiO2) is titrated guided by oxygen saturation in that range; %95<oxygen saturation
ORi+SpO2Procedure or surgery
Titration of fraction of inspired oxygen (FiO2) guided by ORI and oxygen saturation FiO2 will be titrated by reducing 10% if Ori>0.01 and oxygen saturation ≥ 98% until Ori is 0.00.
FiO2 will not be changed if Ori is 0.00 and %95<oxygen saturation≤%98 FiO2 will be increased by 10% if oxygen saturation <95 or PaO2<60 mmHg
| Study group | Role | What they receive |
|---|---|---|
| Control group | In the control group, observation will be conducted solely by another anesthesia doctor or assistant participating in the study, and the data will be recorded blindly without being reported to the anesthesia doctor responsible for the surgery. The oxygen therapy administered by the anesthesia doctor in charge and the FiO2 values will be recorded independently and blindly, based solely on the clinician's own assessment, rather than according to the information obtained from ORi. Subsequently, for two days following the surgery, evaluations will be conducted twice daily at the same hours for ward patients using CAM, and for ICU patients using CAM-ICU. If delirium is detected, delirium subtyping will be performed using the Richmond Agitation-Sedation Scale (RASS). Receives: Procedure: control | |
| ORi+SpO2 group | In the SpO2+ORi group; It is aimed to maintain SpO2 between %95 and %98, and ORi at 0.00.
Data will be recorded every 10 minutes. After extubation, patients will first be evaluated in the postoperative recovery room. Subsequently, for two days following the surgery, evaluations will be conducted twice daily at the same hours for ward patients using CAM, and for ICU patients using CAM-ICU. If delirium is detected, delirium subtyping will be performed using the Richmond Agitation-Sedation Scale (RASS). Receives: Procedure: ORi+SpO2 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Correlation of FiO2 and ORi value
Correlation of FiO2 value and ORi value. FiO2 adjusted until ORi reaches to zero and %95<oxygen saturation≤%98
Measured: Until the surgery is over
Correlation of ORi and Delirium
Correlation of ORİ and SpO2 values with delirium measured by CAM and CAM-ICU
Measured: Up to 48 hours
Secondary outcomes (1)
Correlation of FiO2 and delirium
Correlation of FiO2 and delirium measured by CAM and CAM-ICU
Measured: first 10 th minutes after entubation and every 10 minutes until surgery is over
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Mar 2024
- Study start1 Oct 2023
- Primary completion5 Jul 2024
- Study completion7 Jul 2024
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
- 114 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tepecik Training and Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Aykut Saritas, Tepecik Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06326372
- Sponsor's protocol ID
- Delirium
- Status last verified
- Mar 2024
- First submitted
- 16 Mar 2024
- Last updated
- 9 Jul 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 9 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Intraoperative Hyperoxemia on Postoperative Delirium in Geriatric Patients and the Preventive Role of Oxygen Reserve Index"
- ClinicalTrials.gov ID
- NCT06326372
- Acronym / sponsor ID
- Delirium
- Conditions
- Hyperoxia, Delirium in Old Age
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 114 participants (actual)
- Lead sponsor
- Tepecik Training and Research HospitalUniversity, hospital or other
- Study start
- 1 Oct 2023 (actual)
- Primary completion
- 5 Jul 2024 (actual)
- Study completion
- 7 Jul 2024 (actual)
- First posted
- 22 Mar 2024 (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.
Oxygen therapy is the most common treatment modality for patients with hypoxemia, but target values for normoxemia are not clearly defined. Therefore, iatrogenic hyperoxemia is a very common situation. Even though there are many side effects reported related to hyperoxemia and hyperoxemia is shown to be related to worse outcome than expected; clinicians still observe hyperoxemia frequently.
Oxygen reserve index (ORi™) (Masimo Corp., Irvine, USA) can guide clinicians in detection of hyperoxia. ORi is a parameter which can evaluate partial pressure of oxygen (PaO2) rating from 0 to 1. There are growing evidences in ORi that it might be helpful to reduce hyperoxia in general anesthesia. Continuous ORi monitoring can be used for detecting and preventing hyperoxia. The ability to perform FiO2 titration with ORi may be an appropriate monitoring management to prevent the harmful effects of hyperoxia.In this study, in patients who underwent major abdominal surgery; It was aimed to investigate the effectiveness of ORi-guided FiO2 titration in preventing hyperoxia.
Detailed description
The definition of elderly by the World Health Organization is individuals aged 65 and older. As the average life expectancy continues to increase, the number of surgical procedures performed in the geriatric population is also increasing.
Postoperative delirium is a complication that occurs after surgery and is characterized by sudden-onset confusion, fluctuating mental status, and attention deficits. Its incidence increases in elderly patients and is higher in those with pre-existing mild cognitive impairment. The etiology encompasses multiple factors such as age, presence of additional comorbidities, metabolic disorders, hypoxia, polypharmacy, pain, hypothermia, and may be associated with the depth of anesthesia during surgery.
Early recognition and prevention of delirium will become more prominent in the future due to reduced hospitalization durations, postoperative complications, and mortality rates.
Various methods are available to detect hyperoxemia during surgery. Hyperoxemia can be detected using noninvasive finger pulse oximetry with the oxygen reserve index parameter. Oxygen levels can be noninvasively assessed during operations using routine oxygen saturation and oxygen reserve index measurements.
Delirium can be evaluated in both intensive care and ward patients. The gold standard for diagnosis is the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) criteria. DSM-5 criteria require psychiatric evaluation and are conducted by someone with psychiatric training. Additionally, the Confusion Assessment Method (CAM) is used for diagnosis and can be evaluated as CAM-ICU for intubated patients in intensive care units.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control group | – | Procedure: controlIn the control group, observation will be conducted solely by another anesthesia doctor or assistant participating in the study, and the data will be recorded blindly without being reported to the anesthesia doctor responsible for the surgery. The oxygen therapy administered by the anesthesia doctor in charge and the FiO2 values will be recorded independently and blindly, based solely on the clinician's own assessment, rather than according to the information obtained from ORi. Subsequently, for two days following the surgery, evaluations will be conducted twice daily at the same hours for ward patients using CAM, and for ICU patients using CAM-ICU. If delirium is detected, delirium subtyping will be performed using the Richmond Agitation-Sedation Scale (RASS). |
| ORi+SpO2 group | – | Procedure: ORi+SpO2In the SpO2+ORi group; It is aimed to maintain SpO2 between %95 and %98, and ORi at 0.00. Data will be recorded every 10 minutes. After extubation, patients will first be evaluated in the postoperative recovery room. Subsequently, for two days following the surgery, evaluations will be conducted twice daily at the same hours for ward patients using CAM, and for ICU patients using CAM-ICU. If delirium is detected, delirium subtyping will be performed using the Richmond Agitation-Sedation Scale (RASS). |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
- Study population
- Patients aged 65 and older. Geriatric patients
Key inclusion criteria (4 listed)
- Patients aged 65 and older
- Patients expected to have surgery lasting more than 2 hours
- Patients with ASA (American Society of Anesthesiologists) classification 1-2-3-4
- Patients planned to have at least 2 days of postoperative hospitalization
Key exclusion criteria (8 listed)
- Patients with preoperative central nervous system disorders or dementia
- Patients with MMSE (Mini-Mental State Examination) scores of 23 or below
- Patients unable to communicate
- Emergency surgeries
- Patients who refuse to participate in 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.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| controlFraction of inspired oxygen (FiO2) is titrated guided by oxygen saturation in that range; %95<oxygen saturation | Procedure or surgery | Control group |
| ORi+SpO2Titration of fraction of inspired oxygen (FiO2) guided by ORI and oxygen saturation FiO2 will be titrated by reducing 10% if Ori>0.01 and oxygen saturation ≥ 98% until Ori is 0.00. FiO2 will not be changed if Ori is 0.00 and %95<oxygen saturation≤%98 FiO2 will be increased by 10% if oxygen saturation <95 or PaO2<60 mmHg | Procedure or surgery | ORi+SpO2 group |
Primary outcome
Correlation of FiO2 and ORi value
Time frame: Until the surgery is over
Correlation of FiO2 value and ORi value. FiO2 adjusted until ORi reaches to zero and %95<oxygen saturation≤%98
Correlation of ORi and Delirium
Time frame: Up to 48 hours
Correlation of ORİ and SpO2 values with delirium measured by CAM and CAM-ICU
1 secondary outcome
Correlation of FiO2 and delirium
Time frame: first 10 th minutes after entubation and every 10 minutes until surgery is over
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jul 2024.
- Individual participant dataSharing planned: Undecided
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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. 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 Hyperoxia and Delirium in Old Age, run by Tepecik 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 4 inclusion and 8 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: finished, as of the sponsor's last update on 9 Jul 2024. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Correlation of FiO2 and ORi value (time frame: Until the surgery is over). The study lists 2 primary outcomes in all. 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 9 Jul 2024.