The Effectiveness of the Use of Oxygen Reserve Index in Preventing Hyperoxia in the Intensive Care Unit.
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
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
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| No Intervention: Control group Patients with oxygen saturation > 97% will only be observed. ORi values will be recorded blindly from the clinician. Adjustments to be made in FiO2 will be determined by the intensive care doctor independently of the study, and only observation will be made in this group. |
|
| Active Comparator: ORi+SpO2 (oxygen saturation) group Fraction of inspired oxygen (FiO2) is titrated guided by oxygen saturation in that range; %95<oxygen saturation≤%98 |
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
|
Outcome Measures
Primary Outcome Measures
- 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
- 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)
- Heart rate (HR) [Up to 48 hours]
Measurement of heart rate (HR)
- Positive end-expiratory pressure (PEEP) [Up to 48 hours]
Measurement of PEEP
Eligibility Criteria
Criteria
Inclusion Criteria:
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Patients older than 18 years,
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Patients whose oxygen saturation >97%
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Patients that have invasive arterial monitorization
Exclusion Criteria:
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Patients younger than 18
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Patients that need to be treated with high doses of vasopressors,
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Patients having peripheric hypoperfusion,
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Hemodynamically unstable patients,
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Patients with hemoglobinopathy,
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Pregnancy,
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Morbid obesity (bmi>40 kg/m2),
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Patients with arrythmia that can result in hemodynamic instability, patients with acute coronary syndrome
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Acute respiratory failure or ARDS.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Tepecik Research and Training Hospital | Izmir | Konak | Turkey | 35110 |
Sponsors and Collaborators
- Tepecik Training and Research Hospital
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
- 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.
- 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.
- 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.
- 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.
- 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.
- Health Sciences University