ORI-Guided Oxygen Therapy During One-Lung Ventilation
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age19+
SponsorKonkuk University Medical Center
About this trial
High inspired oxygen concentrations (FiO₂) are commonly administered during general anesthesia to prevent hypoxemia. However, excessive oxygen administration may result in hyperoxemia, which has been associated with impaired hypoxic pulmonary vasoconstriction, increased oxidative stress, ventilation-perfusion mismatch, and postoperative pulmonary complications.
During one-lung ventilation (OLV) for thoracic surgery, higher FiO₂ is often required because of increased intrapulmonary shunting, making hyperoxemia a frequent occurrence. The Oxygen Reserve Index (ORI) is a noninvasive pulse oximetry-derived parameter that reflects moderate hyperoxemia (PaO₂ approximately 100-200 mmHg) and may facilitate more precise oxygen titration than pulse oximetry alone.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Adults aged ≥19 years
Scheduled for elective lung surgery requiring one-lung ventilation
Written informed consent
Disqualifiers
Severe pulmonary hypertension.
Left ventricular systolic dysfunction.
The participant or legally authorized representative requests withdrawal from the study.
An adverse event occurs that precludes continued participation in the study.
Trial design
Design model
Parallel
Treatments tested in this trial
ORI-Guided FiO2 Titration
Other interventionDuring one-lung ventilation, FiO₂ is adjusted according to both ORI and SpO₂. FiO₂ is titrated to maintain SpO₂ ≥98% while keeping ORI above 0 to minimize hyperoxemia.
Conventional SpO₂-Guided FiO₂ Titration
Other interventionDuring one-lung ventilation, FiO₂ is adjusted according to SpO₂ alone. FiO₂ is titrated to maintain SpO₂ ≥98% according to the institutional standard of care.
Treatment groups
58 Participants
are divided into 2 treatment groupsGroup A: ORI-Guided FiO2 TitrationActive comparator 1 intervention
Group B: Conventional SpO₂-Guided FiO₂ TitrationActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Incidence of hyperoxemia during one-lung ventilation
Hyperoxemia is defined as an arterial partial pressure of oxygen (PaO₂) greater than 125 mmHg measured after initiation of one-lung ventilation.
Time frame
10 min after initiation of one-lung ventilation during operationSecondary outcomes
1
Peripheral oxygen saturation (SpO₂)
Peripheral oxygen saturation
Time frame
10 mins after two-lung ventilation, 10 mins after initiation of one-lung ventilation, and 10 mins after resumption of two-lung ventilation, all time frames are included in anesthesia time2
Oxygen Reserve Index (ORI)
Oxygen Reserve Index measured during anesthesia.
Time frame
10 mins after two-lung ventilation, 10 mins after initiation of one-lung ventilation, and 10 mins after resumption of two-lung ventilation, all time frames are included in anesthesia time3
Arterial oxygen tension (PaO₂)
Arterial partial pressure of oxygen measured by arterial blood gas analysis.
Time frame
10 mins after two-lung ventilation, 10 mins after initiation of one-lung ventilation, and 10 mins after resumption of two-lung ventilation, all time frames are included in anesthesia time4
Fraction of inspired oxygen (FiO₂)
Fraction of inspired oxygen administered during anesthesia.
Time frame
10 mins after two-lung ventilation, 10 mins after initiation of one-lung ventilation, and 10 mins after resumption of two-lung ventilation, all time frames are included in anesthesia timeSponsors and contacts
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Source ClinicalTrials.gov
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