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

Chronic Obstructive Pulmonary Disease Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02490657
• Other study ID #: 4-2015-0283
• Status: Completed
• Phase: N/A
• First received: June 15, 2015
• Last updated: June 19, 2016
• Start date: July 2015
• Est. completion date: May 2016

Study information

• Verified date: June 2016
• Source: Yonsei University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 44
• Est. completion date: May 2016
• Est. primary completion date: May 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 40 Years to 80 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Investigator)

Related Conditions & MeSH terms

• Chronic Obstructive Pulmonary Disease
• Lung Diseases
• Lung Diseases, Obstructive
• Pulmonary Disease, Chronic Obstructive
• Video-assisted Thoracoscopic Surgery

Intervention

Drug:
• Inhaled iloprost
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.
• normal saline (Saline 0.9%)

Locations

Country	Name	City	State
Korea, Republic of	Department of Anesthesiology and Pain Medicine, Anesthesia and Pain Research Institue, Yonsei Universiy College of Medicine	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Yonsei University

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Tei-index (tissue Doppler image-derived myocardial performance ) at lateral and septal	Tei-index (tissue Doppler image-derived myocardial performance ) at lateral and septal	myocardial performance changes from baseline(baseline), 60 min after nebulizing iloprost or normal saline (ILO)	Yes
Primary	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)	Yes
Secondary	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)	Yes