Ignite Creation Date:
2024-05-06 @ 8:17 PM
Last Modification Date:
2024-10-26 @ 3:24 PM
Study NCT ID:
NCT06326372
Status:
COMPLETED
Last Update Posted:
2024-07-09
First Post:
2024-03-16
Brief Title:
The Effect of Intraoperative Hyperoxemia on Postoperative Delirium in Geriatric Patients
Sponsor:
Tepecik Training and Research Hospital
Organization:
Tepecik Training and Research Hospital
Study Overview
Official Title:
The Effect of Intraoperative Hyperoxemia on Postoperative Delirium in Geriatric Patients and the Preventive Role of Oxygen Reserve Index
Status:
COMPLETED
Status Verified Date:
2024-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 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 hyperoxiaIn this study in patients who underwent major abdominal surgery It was aimed to investigate the effectiveness of ORi-guided FiO2 titration in preventing hyperoxia
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 hyperoxiaIn 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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None