Skip to main content
OpenTrials
Completed

NCT Number: NCT02490657

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Video-Assisted Thoracoscopic Surgery Chronic Disease Chronic Obstructive Pulmonary Disease Disease Attributes Lung Diseases Lung Diseases, Obstructive Pathologic Processes Pathological Conditions, Signs and Symptoms Pulmonary Disease, Chronic Obstructive Respiratory Tract Diseases

Age range

40 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

Seoul, 120-752, South Korea

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

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.

normal saline (Saline 0.9%)

Drug

Primary outcomes

  1. PaO2 /FiO2 ratio during one-lung ventilation

    Time frame: 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

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

    E/e' estimated by tissue Doppler index

Other outcomes

  1. Tei-index (tissue Doppler image-derived myocardial performance ) at lateral and septal

    Time frame: myocardial performance changes from baseline(baseline), 60 min after nebulizing iloprost or normal saline (ILO)

    Tei-index (tissue Doppler image-derived myocardial performance ) at lateral and septal

Sponsors and collaborators

Lead sponsor

Yonsei University

Other

Registry information

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Jul 7, 2015
Registry last updated
Jun 21, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.