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

Complication Clinical Trial

Official title:

Determination of the Incidence of Hyperoxia and the Effectiveness of FiO2 Titration Guided by the Oxygen Reserve Index in Preventing Hyperoxia.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05770583
• Other study ID #: Tepecik Training and research
• Status: Completed
• Phase: N/A
• Start date: September 1, 2020
• Est. completion date: March 5, 2023

Study information

• Verified date: March 2023
• Source: Tepecik Training and Research Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 62
• Est. completion date: March 5, 2023
• Est. primary completion date: December 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Complication
• Hyperoxia

Intervention

Procedure:
• 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
• SpO2 (oxygen saturation)
Fraction of inspired oxygen (FiO2) is titrated guided by oxygen saturation in that range; %95<oxygen saturation=%98

Locations

Country	Name	City	State
Turkey	Tepecik Research and Training Hospital	Izmir	Konak

Sponsors (1)

Lead Sponsor	Collaborator
Tepecik Training and Research Hospital

Country where clinical trial is conducted

Turkey, 

References & Publications (5)

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. — View 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. — View 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Correlation of FiO2 and ORi value	Correlation of FiO2 value and ORi value. FiO2 adjusted until ORi reaches to zero and %95	Until the surgery is over
Primary	Correlation of PaO2 and ORI value	Pressure of arterial oxygen is obtain from arterial blood gas analysis as usual practice in 10 min and every hour until surgery is over	Until surgery is over
Secondary	Fraction of inspired oxygen (FiO2)	Fraction of inspired oxygen (FiO2) administered during the surgery	First 10 th min after intubation and every hour until surgery is over
Secondary	Systolic blood pressure (SBP)	Measurement of systolic blood pressure (SBP)	First 10 th min after intubation and every hour until surgery is over
Secondary	Diastolic blood pressure (DBP)	Measurement of diastolic blood pressure (DBP)	First 10 th min after intubation and every hour until surgery is over
Secondary	Heart rate (HR)	Measurement of heart rate (HR)	First 10 th min after intubation and every hour until surgery is over
Secondary	Positive end-expiratory pressure (PEEP)	Measurement of PEEP	First 10 th min after intubation and every hour until surgery is over