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NCT Number: NCT05807815

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

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.

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Key information

Conditions

Hyperoxia Complication Mechanical Ventilation Complication Pathological Conditions, Signs and Symptoms Signs and Symptoms Signs and Symptoms, Respiratory

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Tepecik Research and Training Hospital

Izmir, Konak, 35110, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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

Primary outcomes

  1. Correlation of FiO2 and ORi value

    Time frame: Up to 24 weeks

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

Secondary outcomes

  1. Fraction of inspired oxygen (FiO2)

    Time frame: Up to 48 hours

    Fraction of inspired oxygen (FiO2) in every 4 hour intervals

  2. Mean arterial blood pressure (MAP)

    Time frame: Up to 48 hours

    Measurement of mean arteria blood pressure (SBP)

  3. Heart rate (HR)

    Time frame: Up to 48 hours

    Measurement of heart rate (HR)

  4. Positive end-expiratory pressure (PEEP)

    Time frame: Up to 48 hours

    Measurement of PEEP

Sponsors and collaborators

Lead sponsor

Tepecik Training and Research Hospital

Other

Registry information

Official study 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.

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Apr 11, 2023
Registry last updated
Apr 11, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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