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

NCT ID: NCT02490657

Last Updated: 2016-06-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 44 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-07-31
• Study Completion Date: 2016-05-31

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.

Conditions

Video-assisted Thoracoscopic Surgery; Chronic Obstructive Pulmonary Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Blinding Strategy: DOUBLE

Study Groups

Iloprost group

Group Type: EXPERIMENTAL

Inhaled iloprost

Intervention Type: DRUG

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

Group Type: PLACEBO_COMPARATOR

normal saline (Saline 0.9%)

Intervention Type: DRUG

Interventions

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.

Intervention Type: DRUG

normal saline (Saline 0.9%)

Intervention Type: DRUG

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

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Yonsei University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Department of Anesthesiology and Pain Medicine, Anesthesia and Pain Research Institue, Yonsei Universiy College of Medicine

Seoul, Seoul, South Korea

Countries

South Korea

Other Identifiers

4-2015-0283

Identifier Type: -

Identifier Source: org_study_id