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NCT Number: NCT05770583

The Effectiveness of FiO2 Titration Guided by the Oxygen Reserve Index in Preventing Hyperoxia.

Oxygen therapy is the most common treatment modality for patients with hypoxemia, but target values for normoxemia are not clearly defined. Therefore, iatrogenic hyperoxemia is a very common situation. 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, in patients who underwent major abdominal surgery; It was aimed to investigate the effectiveness of ORi-guided FiO2 titration in preventing hyperoxia.

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Key information

Conditions

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

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Tepecik Research and Training Hospital

Izmir, Konak, 35110, Turkey (Türkiye)

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Patients older than 18,
  • Patients scheduled for major abdominal surgery that are expected to last longer than 2 hours
  • Patients that have invasive arterial monitorization
  • American Society of Anesthesiologists physical class I, II or III.

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

Other names: ORİ+SpO2

SpO2 (oxygen saturation)

Procedure

Fraction of inspired oxygen (FiO2) is titrated guided by oxygen saturation in that range; %95<oxygen saturation≤%98

Primary outcomes

  1. Correlation of FiO2 and ORi value

    Time frame: Until the surgery is over

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

  2. Correlation of PaO2 and ORİ value

    Time frame: Until surgery is over

    Pressure of arterial oxygen is obtain from arterial blood gas analysis as usual practice in 10 min and every hour until surgery is over

Secondary outcomes

  1. Fraction of inspired oxygen (FiO2)

    Time frame: First 10 th min after intubation and every hour until surgery is over

    Fraction of inspired oxygen (FiO2) administered during the surgery

  2. Systolic blood pressure (SBP)

    Time frame: First 10 th min after intubation and every hour until surgery is over

    Measurement of systolic blood pressure (SBP)

  3. Diastolic blood pressure (DBP)

    Time frame: First 10 th min after intubation and every hour until surgery is over

    Measurement of diastolic blood pressure (DBP)

  4. Heart rate (HR)

    Time frame: First 10 th min after intubation and every hour until surgery is over

    Measurement of heart rate (HR)

  5. Positive end-expiratory pressure (PEEP)

    Time frame: First 10 th min after intubation and every hour until surgery is over

    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.

Important dates

Study start
2020
Primary completion
2022
Study completion
2023
First posted
Mar 15, 2023
Registry last updated
Mar 16, 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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