Clinical trial NCT02490657: Effects of Iloprost on Pulmonary Hemodynamics and Oxygenation in Patients of Chronic Obstructive Pulmonary Disease During One-lung Ventilation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Video-assisted Thoracoscopic Surgery
Chronic Obstructive Pulmonary Disease
Lead sponsor: Yonsei University
Sponsor class: OTHER
First posted: 2015-07-07
Enrollment: 44
Sex: ALL
Minimum age (years): 40
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

1. 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.
2. American Society of Anesthesiologists (ASA) Physical Status II, III.
3. Preoperative SpO2 95 % or less at room air (spontaneous ventilation) or 4. PaO2 /FiO2 ratio\< 150 mmHg after initiating one-lung ventilation

Exclusion Criteria:

1. Severe functional liver or kidney disease
2. Diagnosed HF (LV ejection fraction \<50% , or wall motion abnormality)
3. Arrhythmia or received treatment with antiarrythmic drug .
4. 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

Primary outcomes:
measure: PaO2 /FiO2 ratio during one-lung ventilation
timeFrame: 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 outcomes:
measure: biventricular diastolic function
timeFrame: biventricular diastolic function changes from baseline(baseline), 60 min after nebulizing iloprost or normal saline (ILO)
Other outcomes:
measure: Tei-index (tissue Doppler image-derived myocardial performance ) at lateral and septal
timeFrame: myocardial performance changes from baseline(baseline), 60 min after nebulizing iloprost or normal saline (ILO)
Locations:
city: Seoul
country: Korea, Republic of
facility: Department of Anesthesiology and Pain Medicine, Anesthesia and Pain Research Institue, Yonsei Universiy College of Medicine
Study officials:
References: