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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05807815
Other study ID # Health Sciences University
Secondary ID
Status Completed
Phase N/A
First received
Last updated
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
Health authority
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 (ORiā„¢) (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.

Study Design


Related Conditions & MeSH terms


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
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