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Trial record 4 of 61 for:    "Lung Disease" | "Iloprost"

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

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ClinicalTrials.gov Identifier: NCT02490657
Recruitment Status : Completed
First Posted : July 7, 2015
Last Update Posted : June 21, 2016
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Video-assisted Thoracoscopic Surgery Chronic Obstructive Pulmonary Disease Drug: Inhaled iloprost Drug: normal saline (Saline 0.9%) Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 44 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double (Participant, Investigator)
Study Start Date : July 2015
Actual Primary Completion Date : May 2016
Actual Study Completion Date : May 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: COPD Lung Diseases
Drug Information available for: Iloprost

Arm Intervention/treatment
Experimental: Iloprost group 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.


Placebo Comparator: normal saline Drug: normal saline (Saline 0.9%)



Primary Outcome Measures :
  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 Outcome Measures :
  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 Outcome Measures:
  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



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Ages Eligible for Study:   40 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02490657


Locations
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Korea, Republic of
Department of Anesthesiology and Pain Medicine, Anesthesia and Pain Research Institue, Yonsei Universiy College of Medicine
Seoul, Korea, Republic of, 120-752
Sponsors and Collaborators
Yonsei University

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Responsible Party: Yonsei University
ClinicalTrials.gov Identifier: NCT02490657     History of Changes
Other Study ID Numbers: 4-2015-0283
First Posted: July 7, 2015    Key Record Dates
Last Update Posted: June 21, 2016
Last Verified: June 2016
Additional relevant MeSH terms:
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Lung Diseases
Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Respiratory Tract Diseases
Iloprost
Platelet Aggregation Inhibitors
Vasodilator Agents