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

NCT02490657 | Completed

• 1 other identifier: 4-2015-0283
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• biventricular diastolic function

  biventricular diastolic function changes from baseline(baseline), 60 min after nebulizing iloprost or normal saline (ILO)

Other Outcomes (1)

• 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)

Study Arms (2)

Iloprost group

EXPERIMENTAL

Drug: Inhaled iloprost

normal saline

PLACEBO COMPARATOR

Drug: normal saline (Saline 0.9%)

Interventions

Inhaled iloprost 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.

Iloprost group

normal saline (Saline 0.9%) DRUG

normal saline

Eligibility Criteria

• Age: 40 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Yonsei University: lead

Study Sites (1)

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

Seoul, Seoul, 120-752, South Korea

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Interventions

Saline Solution; Sodium Chloride

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 15, 2015
• First Posted: July 7, 2015
• Study Start: July 1, 2015
• Primary Completion: May 1, 2016
• Study Completion: May 1, 2016
• Last Updated: June 21, 2016

Record last verified: 2016-06

Locations

KR (1)