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

NCT05807815 | Completed DMC

• 1 other identifier: Health Sciences University
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Hyperoxia; Complication; Mechanical Ventilation Complication

Keywords

Hyperoxia; Fraction of inspired oxygen; Intensive care unit

Outcome Measures

Primary Outcomes (1)

• Correlation of FiO2 and ORi value

  Correlation of FiO2 value and ORi value. FiO2 adjusted until ORi reaches to zero and %95\<oxygen saturation≤%98

  Up to 24 weeks

Secondary Outcomes (4)

• Fraction of inspired oxygen (FiO2)

  Up to 48 hours

• Mean arterial blood pressure (MAP)

  Up to 48 hours

• Heart rate (HR)

  Up to 48 hours

• Positive end-expiratory pressure (PEEP)

  Up to 48 hours

Study Arms (2)

Control group

NO INTERVENTION

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.

ORi+SpO2 (oxygen saturation) group

ACTIVE COMPARATOR

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

Interventions

Titration of fraction of inspired oxygen (FiO2) guided by ORI and oxygen saturation PROCEDURE

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

ORi+SpO2 (oxygen saturation) group

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients older than 18 years,
• Patients whose oxygen saturation \>97%
• Patients that have invasive arterial monitorization

You may not qualify if:

• 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.

Sponsors & Collaborators

• Tepecik Training and Research Hospital: lead

Study Sites (1)

Tepecik Research and Training Hospital

Izmir, Konak, 35110, Turkey (Türkiye)

Location

Related 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.

  PMID: 20878146 BACKGROUND

• 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.

  PMID: 24164953 BACKGROUND

• 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.

  PMID: 21994818 BACKGROUND

• 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.

  PMID: 29445905 BACKGROUND

• 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.

  PMID: 31227971 BACKGROUND

MeSH Terms

Conditions

Hyperoxia

Interventions

Oxygen Saturation

Condition Hierarchy (Ancestors)

Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Metabolism

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: associated professor

Study Record Dates

• First Submitted: March 15, 2023
• First Posted: April 11, 2023
• Study Start: March 1, 2021
• Primary Completion: March 1, 2023
• Study Completion: March 13, 2023
• Last Updated: April 11, 2023

Record last verified: 2023-03

Locations

TU (1)