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

Tepecik Training and Research Hospital

Status: Completed

Conditions: Complication; Hyperoxia

Treatments: Procedure: SpO2 (oxygen saturation); Procedure: Titration of fraction of inspired oxygen (FiO2) guided by ORI and oxygen saturation

Study type: Interventional

Funder types: Other

Identifiers

NCT05770583

Tepecik Training and research

Details and patient eligibility

About

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.

Enrollment: 62 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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62 participants in 2 patient groups

Control group

Active Comparator group

Description:

Fraction of inspired oxygen (FiO2) is titrated guided by oxygen saturation in that range; %95\<oxygen saturation≤%98

Treatment:

Procedure: SpO2 (oxygen saturation)

ORi+SpO2 (oxygen saturation) group

Experimental group

Description:

* FiO2 will be titrated by reducing 10% if Ori\>0.01 andSpO2 ≥ 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

Treatment:

Procedure: Titration of fraction of inspired oxygen (FiO2) guided by ORI and oxygen saturation