Mediastinal Mass
Conditions
Brief summary
One-lung ventilation (OLV) is essential during mediastinal mass excision. However, OLV induces a drastic increase of intrapulmonary shunt due to maintained pulmonary perfusion through the nonventilated lung. In addition, it is reported that supine positioning of patient during OLV, which is required during mediastinal mass excision, results in worse oxygenation than lateral decubitus positioning. Iloprost is a prostaglandin analogue and when inhaled during OLV, it acts selectively on the pulmonary vasculature, reducing pulmonary vascular resistance of well-ventilated lung and thereby alleviating ventilation-perfusion mismatch. The purpose of this study is to evaluate the effects of inhaled iloprost on oxygenation during one-lung ventilation in patients undergoing mediastinal mass excision.
Interventions
After the initiation of OLV, 5ml of normal saline is inhaled for 20 minutes using ultrasonic nebulizer, which is connected to the inspiratory limb of the ventilator system. Arterial blood gas analysis is performed 20 minutes after the completion of drug inhalation.
DRUG20μg (2ml) of inhaled iloprost (Ventavis®) and 3ml of inhaled normal saline
After the initiation of OLV, mixture of iloprost 2ml and normal saline 3ml is inhaled for 20 minutes using ultrasonic nebulizer, which is connected to the inspiratory limb of the ventilator system. Arterial blood gas analysis is performed 20 minutes after the completion of drug inhalation.
Sponsors
Yonsei University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
20 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
1. Patients scheduled for Video-assisted thoracoscopic surgery (VATS) mediastinal mass excision 2. Patient age from 20 to 80 3. American Society of Anaesthesiologists (ASA) physical status classification II\ III
Exclusion criteria
1. Chronic obstructive pulmonary disease (COPD) with Forced expiratory volume in 1 second (FEV1) to Forced vital capacity (FVC) ratio \< 0.7 and percentage of predicted FEV1 ≤ 80% 2. Diffusing capacity of carbon monoxide (DLCO) \< 80% 3. Aspartate transaminase (AST) level ≥100 IU/mL or alanine transaminase (ALT) ≥ level 50 IU/L 4. Creatinine clearance ≤ 30mL/min 5. Congestive heart failure, arrhythmia 6. Unstable angina, coronary artery occlusive disease (CAOD), history of myocardial infarction within 6 months 7. Pulmonary edema, pulmonary arterial hypertension 8. Allergic to prostaglandin or prostacyclin analogue 9. Patients with peptic ulcer bleeding, trauma, intracranial hemorrhage 10. History of cerebrovascular disease (e.g. transient ischemic attack, stroke) within 3 months 11. Valvular heart disease 12. Pregnant women
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| PaO2 (partial pressure of arterial oxygen) to FiO2 (fraction of inspired oxygen) ratio (P/F ratio) | Twenty minutes after the completion of drug inhalation | The P/F ratio is a widely-used objective tool to identify hypoxemic respiratory failure when supplemental oxygen has been administered. It can be used to evaluate the effect of iloprost on oxygenation during OLV. |
Countries
South Korea
Contacts
Primary ContactKyuho Lee
Outcome results
None listed