Determination of the Incidence of Hyperoxia and the Effectiveness of FiO2 Titration Guided by the Oxygen Reserve Index in Preventing Hyperoxia in Mechanically Ventilated Patients in the Intensive Care Unit.
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 60
- Locations
- 2
- Primary Endpoint
- Correlation of FiO2 and ORi value
Study Overview
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 Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- Triple (Participant, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 85 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Outcomes
Primary Outcomes
Correlation of FiO2 and ORi value
Time Frame: Up to 24 weeks
Correlation of FiO2 value and ORi value. FiO2 adjusted until ORi reaches to zero and %95\<oxygen saturation≤%98
Secondary Outcomes
- Heart rate (HR)(Up to 48 hours)
- Positive end-expiratory pressure (PEEP)(Up to 48 hours)
- Fraction of inspired oxygen (FiO2)(Up to 48 hours)
- Mean arterial blood pressure (MAP)(Up to 48 hours)
Investigators
Aykut Saritas
associated professor
Tepecik Training and Research Hospital