Clinical trial NCT05770583: The Effectiveness of FiO2 Titration Guided by the Oxygen Reserve Index in Preventing Hyperoxia.
Official title: Determination of the Incidence of Hyperoxia and the Effectiveness of FiO2 Titration Guided by the Oxygen Reserve Index in Preventing Hyperoxia.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hyperoxia
Complication
Lead sponsor: Tepecik Training and Research Hospital
Sponsor class: OTHER
First posted: 2023-03-15
Enrollment: 62
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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 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.


Eligibility criteria: Inclusion Criteria:

1. Patients older than 18,
2. Patients scheduled for major abdominal surgery that are expected to last longer than 2 hours
3. Patients that have invasive arterial monitorization
4. American Society of Anesthesiologists physical class I, II or III.

Exclusion Criteria:

1. Patients younger than 18
2. Patients that need to be treated with high doses of vasopressors,
3. Patients having peripheric hypoperfusion,
4. Hemodynamically unstable patients,
5. Patients with hemoglobinopathy,
6. Pregnancy,
7. Morbid obesity (bmi\>40 kg/m2),
8. Patients with arrythmia that can result in hemodynamic instability, patients with acute coronary syndrome
9. Acute respiratory failure or ARDS.

Primary outcomes:
measure: Correlation of FiO2 and ORi value
timeFrame: Until the surgery is over
measure: Correlation of PaO2 and ORİ value
timeFrame: Until surgery is over
Secondary outcomes:
measure: Fraction of inspired oxygen (FiO2)
timeFrame: First 10 th min after intubation and every hour until surgery is over
measure: Systolic blood pressure (SBP)
timeFrame: First 10 th min after intubation and every hour until surgery is over
measure: Diastolic blood pressure (DBP)
timeFrame: First 10 th min after intubation and every hour until surgery is over
measure: Heart rate (HR)
timeFrame: First 10 th min after intubation and every hour until surgery is over
measure: Positive end-expiratory pressure (PEEP)
timeFrame: First 10 th min after intubation and every hour until surgery is over
Other outcomes:
Locations:
city: Izmir
country: Turkey
facility: Tepecik Research and Training Hospital
state: Konak
Study officials:
References:
citation: Pala Cifci S, Urcan Tapan Y, Turemis Erkul B, Savran Y, Comert B. The Impact of Hyperoxia on Outcome of Patients Treated with Noninvasive Respiratory Support. Can Respir J. 2020 May 6;2020:3953280. doi: 10.1155/2020/3953280. eCollection 2020.
citation: Mach WJ, Thimmesch AR, Pierce JT, Pierce JD. Consequences of hyperoxia and the toxicity of oxygen in the lung. Nurs Res Pract. 2011;2011:260482. doi: 10.1155/2011/260482. Epub 2011 Jun 5.
citation: Vos JJ, Willems CH, van Amsterdam K, van den Berg JP, Spanjersberg R, Struys MMRF, Scheeren TWL. Oxygen Reserve Index: Validation of a New Variable. Anesth Analg. 2019 Aug;129(2):409-415. doi: 10.1213/ANE.0000000000003706.
citation: Yoshida K, Isosu T, Noji Y, Ebana H, Honda J, Sanbe N, Obara S, Murakawa M. Adjustment of oxygen reserve index (ORi) to avoid excessive hyperoxia during general anesthesia. J Clin Monit Comput. 2020 Jun;34(3):509-514. doi: 10.1007/s10877-019-00341-9. Epub 2019 Jun 22.
citation: Scheeren TWL, Belda FJ, Perel A. Correction to: The oxygen reserve index (ORI): a new tool to monitor oxygen therapy. J Clin Monit Comput. 2018 Jun;32(3):579-580. doi: 10.1007/s10877-018-0104-9.