Thoracic Surgery With One-lung Ventilation
Conditions
Keywords
One-Lung Ventilation, hyperoxia
Brief summary
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.
Detailed description
This prospective, randomized, assessor-blinded clinical trial aims to determine whether FiO₂ titration guided by both ORI and peripheral oxygen saturation (SpO₂) reduces the incidence of hyperoxemia compared with conventional SpO₂-guided FiO₂ titration during OLV in patients undergoing thoracic surgery. Participants will be randomly assigned to either an ORI-guided group or a conventional SpO₂-guided group. The primary outcome is the incidence of hyperoxemia (PaO₂ \>125 mmHg) after OLV. Secondary outcomes include SpO₂, ORI, PaO₂, and FiO₂ measured
Interventions
OTHERORI-Guided FiO2 Titration
During 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.
OTHERConventional SpO₂-Guided FiO₂ Titration
During one-lung ventilation, FiO₂ is adjusted according to SpO₂ alone. FiO₂ is titrated to maintain SpO₂ ≥98% according to the institutional standard of care.
Sponsors
Konkuk University Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
19 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Adults aged ≥19 years * Scheduled for elective lung surgery requiring one-lung ventilation * Written informed consent
Exclusion criteria
* Severe pulmonary hypertension. * Left ventricular systolic dysfunction. Withdrawal Criteria: * The participant or legally authorized representative requests withdrawal from the study. * An adverse event occurs that precludes continued participation in the study. * The planned surgery or study procedures are not performed (e.g., ORI monitoring is not applied or arterial blood gas analysis is not performed). * Perfusion Index is less than 2 during the study. * A major violation of the inclusion or
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of hyperoxemia during one-lung ventilation | 10 min after initiation of one-lung ventilation during operation | Hyperoxemia is defined as an arterial partial pressure of oxygen (PaO₂) greater than 125 mmHg measured after initiation of one-lung ventilation. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Peripheral oxygen saturation (SpO₂) | 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 time | Peripheral oxygen saturation |
| Oxygen Reserve Index (ORI) | 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 time | Oxygen Reserve Index measured during anesthesia. |
| Arterial oxygen tension (PaO₂) | 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 time | Arterial partial pressure of oxygen measured by arterial blood gas analysis. |
| Fraction of inspired oxygen (FiO₂) | 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 time | Fraction of inspired oxygen administered during anesthesia. |
Countries
South Korea
Contacts
CONTACTTae-Yop Kim
CONTACTChungsik Oh
Outcome results
None listed