Clinical Trials Directory

Trials / Completed

CompletedNCT05807815

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

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.

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
60 (actual)
Sponsor
Tepecik Training and Research Hospital · Academic / Other
Sex
All
Age
18 Years – 85 Years
Healthy volunteers
Not accepted

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.

Conditions

Interventions

TypeNameDescription
PROCEDURETitration of fraction of inspired oxygen (FiO2) guided by ORI and oxygen saturationFiO2 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

Timeline

Start date
2021-03-01
Primary completion
2023-03-01
Completion
2023-03-13
First posted
2023-04-11
Last updated
2023-04-11

Locations

1 site across 1 country: Turkey (Türkiye)

Source: ClinicalTrials.gov record NCT05807815. Inclusion in this directory is not an endorsement.