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

Not Applicable

Completed

• Conditions: Video-assisted Thoracoscopic Surgery; Chronic Obstructive Pulmonary Disease
• Interventions: Drug: Inhaled iloprost; Drug: normal saline (Saline 0.9%)

• Registration Number: NCT02490657
• Lead Sponsor: Yonsei University

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2015-06-15
• Study Start: 2015-07
• Study First Submitted QC: 2015-07-01
• Study First Posted: 2015-07-07
• Primary Completion: 2016-05
• Study Completion: 2016-05
• Status Verified: 2016-06
• Last Update Submitted: 2016-06-19
• Last Update Posted: 2016-06-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 44

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Iloprost group	Inhaled iloprost	-
normal saline	normal saline (Saline 0.9%)	-

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
biventricular diastolic function	biventricular diastolic function changes from baseline(baseline), 60 min after nebulizing iloprost or normal saline (ILO)	E/e' estimated by tissue Doppler index

Trial Locations

Locations (1)

Department of Anesthesiology and Pain Medicine, Anesthesia and Pain Research Institue, Yonsei Universiy College of Medicine; 🇰🇷 Seoul, Korea, Republic of