The Effectiveness of FiO2 Titration Guided by the Oxygen Reserve Index in Preventing Hyperoxia.

Not Applicable

Completed

• Conditions: Complication; Hyperoxia

• Registration Number: NCT05770583
• Lead Sponsor: Tepecik Training and Research Hospital

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-09-01
• Primary Completion: 2022-12-01
• Status Verified: 2023-03
• Study Completion: 2023-03-05
• Study First Submitted: 2023-03-05
• Study First Submitted QC: 2023-03-05
• Last Update Submitted: 2023-03-14
• Study First Posted: 2023-03-15
• Last Update Posted: 2023-03-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 62

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Correlation of FiO2 and ORi value	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 PaO2 and ORİ value	Until surgery is over	Pressure of arterial oxygen is obtain from arterial blood gas analysis as usual practice in 10 min and every hour until surgery is over

Secondary Outcome Measures

Name	Time	Method
Heart rate (HR)	First 10 th min after intubation and every hour until surgery is over	Measurement of heart rate (HR)
Diastolic blood pressure (DBP)	First 10 th min after intubation and every hour until surgery is over	Measurement of diastolic blood pressure (DBP)
Positive end-expiratory pressure (PEEP)	First 10 th min after intubation and every hour until surgery is over	Measurement of PEEP
Systolic blood pressure (SBP)	First 10 th min after intubation and every hour until surgery is over	Measurement of systolic blood pressure (SBP)
Fraction of inspired oxygen (FiO2)	First 10 th min after intubation and every hour until surgery is over	Fraction of inspired oxygen (FiO2) administered during the surgery

Trial Locations

Locations (1)

Tepecik Research and Training Hospital; 🇹🇷 Izmir, Konak, Turkey