An observational study in Hyperoxia and Delirium in Old Age, sponsored by Tepecik Training and Research Hospital. Completed at 1 site in Turkey. Open to participants aged 65 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-07-09.
Sponsored by Tepecik Training and Research Hospital · Observational
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.
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.
115 studies on the registry are indexed under Hyperoxia; 13 are open to participants now.
This study's enrollment of 114 is close to the median of 104 across 32 observational studies indexed under Hyperoxia.
Browse Hyperoxia studies →Tepecik Training and Research Hospital is the lead sponsor of 33 studies on the registry; 3 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Patients aged 65 and older. Geriatric patients
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
Short tests of memory and thinking, each scored out of 30. Lower scores suggest more difficulty; criteria give a range, either to include people with memory problems or to leave them out.
ASA physical status
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
MMSE and MoCA
Short tests of memory and thinking, each scored out of 30. Lower scores suggest more difficulty; criteria give a range, either to include people with memory problems or to leave them out.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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).
Procedure: control
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).
Procedure: ORi+SpO2
Fraction of inspired oxygen (FiO2) is titrated guided by oxygen saturation in that range; %95\<oxygen saturation
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
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
Time frame: Until the surgery is over
Correlation of ORi and Delirium
Correlation of ORİ and SpO2 values with delirium measured by CAM and CAM-ICU
Time frame: Up to 48 hours
Correlation of FiO2 and delirium
Correlation of FiO2 and delirium measured by CAM and CAM-ICU
Time frame: first 10 th minutes after entubation and every 10 minutes until surgery is over
Plan to share: Undecided
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This study is completed, as verified in Mar 2024. You cannot join it, but the record below documents what was studied.
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Tepecik Training and Research Hospital