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

Not Applicable

Completed

• Conditions: Mechanical Ventilation Complication; Hyperoxia; Complication
• Interventions: Procedure: Titration of fraction of inspired oxygen (FiO2) guided by ORI and oxygen saturation

• Registration Number: NCT05807815
• Lead Sponsor: Tepecik Training and Research Hospital

Brief Summary

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.

Detailed 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.

Study Timeline

• Study Start: 2021-03-01
• Status Verified: 2023-03
• Primary Completion: 2023-03-01
• Study Completion: 2023-03-13
• Study First Submitted: 2023-03-15
• Study First Submitted QC: 2023-03-29
• Last Update Submitted: 2023-03-29
• Study First Posted: 2023-04-11
• Last Update Posted: 2023-04-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
ORi+SpO2 (oxygen saturation) group	Titration of fraction of inspired oxygen (FiO2) guided by ORI and oxygen saturation	Fraction of inspired oxygen (FiO2) is titrated guided by oxygen saturation in that range; %95\<oxygen saturation≤%98

Primary Outcome Measures

Name	Time	Method
Correlation of FiO2 and ORi value	Up to 24 weeks	Correlation of FiO2 value and ORi value. FiO2 adjusted until ORi reaches to zero and %95\<oxygen saturation≤%98

Secondary Outcome Measures

Name	Time	Method
Heart rate (HR)	Up to 48 hours	Measurement of heart rate (HR)
Positive end-expiratory pressure (PEEP)	Up to 48 hours	Measurement of PEEP
Fraction of inspired oxygen (FiO2)	Up to 48 hours	Fraction of inspired oxygen (FiO2) in every 4 hour intervals
Mean arterial blood pressure (MAP)	Up to 48 hours	Measurement of mean arteria blood pressure (SBP)

Trial Locations

Locations (1)

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