The Effectiveness of the Use of Oxygen Reserve Index in Preventing Hyperoxia in the Intensive Care Unit.

Tepecik Training and Research Hospital

Status: Completed

Conditions: Mechanical Ventilation Complication; Complication; Hyperoxia

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

Study type: Interventional

Funder types: Other

Identifiers

NCT05807815

Health Sciences University

Details and patient eligibility

About

Oxygen therapy is the most common treatment modality for patients with hypoxemia in intensive care units, but target values for normoxemia are not clearly defined. Therefore, iatrogenic hyperoxemia is a very common situation. In intensive care units, FiO2 is usually adjusted according to hypoxia and hyperoxia is ignored in patients under mechanical ventilator support. 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.

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, it was aimed to investigate the effectiveness of ORi-guided FiO2 titration in preventing hyperoxia in patients undergoing mechanical ventilation in the intensive care unit and to determine the incidence of hyperoxia.

Full description

In intensive care units, FiO2 is usually adjusted according to hypoxia and hyperoxia is ignored in patients under mechanical ventilator support. 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, it was aimed to investigate the effectiveness of ORi-guided FiO2 titration in preventing hyperoxia in patients undergoing mechanical ventilation in the intensive care unit and to determine the incidence of hyperoxia.

Enrollment: 60 patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients older than 18 years,
• Patients whose oxygen saturation >97%
• Patients that have invasive arterial monitorization

Exclusion criteria

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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60 participants in 2 patient groups

Control group

No Intervention group

Description:

Patients with oxygen saturation \> 97% will only be observed. ORi values will be recorded blindly from the clinician. Adjustments to be made in FiO2 will be determined by the intensive care doctor independently of the study, and only observation will be made in this group.

ORi+SpO2 (oxygen saturation) 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: Titration of fraction of inspired oxygen (FiO2) guided by ORI and oxygen saturation