Effects of Iloprost on Pulmonary Hemodynamics and Oxygenation in Patients of Chronic Obstructive Pulmonary Disease During One-lung Ventilation

Study Overview
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Brief Summary
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The inhaled Iloprost, approved for pulmonary hypertension, caused increase in oxygenation, and increase exercise tolerance in ARDS or chronic obstructive pulmonary disease. Inhaled iloprost has been researched in animal study, but not yet in human during one-lung ventilation. The investigators will enroll patients who diagnosed moderate to severe chronic obstructive pulmonary disease, preoperative pulse oximetry (SpO2) of below 95% at room air or PaO2 /FiO2 ratio< 150 mmHg after initiating one-lung ventilation. The primary outcome is pulmonary oxygenation expressed by PaO2 /FiO2 ratio. And secondary outcome is assessment of cardiac function including Tei-index during nebulizing iloprost. The investigators hypothesized inhaled iloprost will improve oxygenation and decrease the FiO2 in chronic obstructive pulmonary disease during one-lung ventilation.

Conditions
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Video-assisted Thoracoscopic Surgery, Chronic Obstructive Pulmonary Disease

Intervention / Treatment
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* Drug: Inhaled iloprost
* Drug: normal saline (Saline 0.9%)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Chronic obstructive pulmonary disease was defined as FEV1/FVC ratio < 0.7 and an FEV 1 of 80% or less after inhalation bronchodilator : 1. Above 40 years of age. American Society of Anesthesiologists (ASA) Physical Status II, III. Preoperative SpO2 95 % or less at room air (spontaneous ventilation) or 4. PaO2 /FiO2 ratio< 150 mmHg after initiating one-lung ventilation Exclusion Criteria: Severe functional liver or kidney disease Diagnosed HF (LV ejection fraction <50% , or wall motion abnormality) Arrhythmia or received treatment with antiarrythmic drug . Severe bradycardia(HR < 45 bpm) and AV block 6. pathologic esophageal lesion (esophageal stricture or varix ) 7. pregnancy 8. PaO2 /FiO2 ratio ≥ 150 mmHg after initiating one-lung ventilation

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Iloprost group<br> | Drug: Inhaled iloprost<br>* Nebulized agents (Iloprost or normal saline) were randomized by computer-generated randomization. The patients and anesthesiologist, who administered inhalation and conducted all this trial, were blinded to the medication allocation. An anesthesiologist, who responsible for preparation of medication, was the only person recognizing of the randomization code during trial. Enrolled patients were received 20 μg iloprost or placebo (norma saline). Iloprost was diluted in normal saline to obtain 2ml solution. Control group were inhaled comparable dose of normal saline. Iloprost or normal saline was inhaled through an ultrasonic nebulized system in inspiratory limb.<br>|
| Placebo Comparator: normal saline<br> | Drug: normal saline (Saline 0.9%)<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PaO2 /FiO2 ratio during one-lung ventilation |  | oxygenation changes from baseline (OLV), in 30 min after nebulizing iloprost or normal saline(ILO-30), in 60 min after nebulizing iloprost or normal saline(ILO-60), to after 20 min in postanaestheticcare unit(PACU) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| biventricular diastolic function | E/e' estimated by tissue Doppler index | biventricular diastolic function changes from baseline(baseline), 60 min after nebulizing iloprost or normal saline (ILO) |