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

Mechanical Ventilation Complication Clinical Trial

Official title:

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05807815
• Other study ID #: Health Sciences University
• Status: Completed
• Phase: N/A
• Start date: March 1, 2021
• Est. completion date: March 13, 2023

Study information

• Verified date: March 2023
• Source: Tepecik Training and Research Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: March 13, 2023
• Est. primary completion date: March 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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.

Related Conditions & MeSH terms

• Complication
• Hyperoxia
• Mechanical Ventilation Complication

Intervention

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

Locations

Country	Name	City	State
Turkey	Tepecik Research and Training Hospital	Izmir	Konak

Sponsors (1)

Lead Sponsor	Collaborator
Tepecik Training and Research Hospital

Country where clinical trial is conducted

Turkey, 

References & Publications (5)

de Graaff AE, Dongelmans DA, Binnekade JM, de Jonge E. Clinicians' response to hyperoxia in ventilated patients in a Dutch ICU depends on the level of FiO2. Intensive Care Med. 2011 Jan;37(1):46-51. doi: 10.1007/s00134-010-2025-z. Epub 2010 Sep 28. — View Citation

Mach WJ, Thimmesch AR, Pierce JT, Pierce JD. Consequences of hyperoxia and the toxicity of oxygen in the lung. Nurs Res Pract. 2011;2011:260482. doi: 10.1155/2011/260482. Epub 2011 Jun 5. — View Citation

Rincon F, Kang J, Maltenfort M, Vibbert M, Urtecho J, Athar MK, Jallo J, Pineda CC, Tzeng D, McBride W, Bell R. Association between hyperoxia and mortality after stroke: a multicenter cohort study. Crit Care Med. 2014 Feb;42(2):387-96. doi: 10.1097/CCM.0b013e3182a27732. — View Citation

Scheeren TWL, Belda FJ, Perel A. Correction to: The oxygen reserve index (ORI): a new tool to monitor oxygen therapy. J Clin Monit Comput. 2018 Jun;32(3):579-580. doi: 10.1007/s10877-018-0104-9. — View Citation

Yoshida K, Isosu T, Noji Y, Ebana H, Honda J, Sanbe N, Obara S, Murakawa M. Adjustment of oxygen reserve index (ORi) to avoid excessive hyperoxia during general anesthesia. J Clin Monit Comput. 2020 Jun;34(3):509-514. doi: 10.1007/s10877-019-00341-9. Epub 2019 Jun 22. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Correlation of FiO2 and ORi value	Correlation of FiO2 value and ORi value. FiO2 adjusted until ORi reaches to zero and %95	Up to 24 weeks
Secondary	Fraction of inspired oxygen (FiO2)	Fraction of inspired oxygen (FiO2) in every 4 hour intervals	Up to 48 hours
Secondary	Mean arterial blood pressure (MAP)	Measurement of mean arteria blood pressure (SBP)	Up to 48 hours
Secondary	Heart rate (HR)	Measurement of heart rate (HR)	Up to 48 hours
Secondary	Positive end-expiratory pressure (PEEP)	Measurement of PEEP	Up to 48 hours