Effect of Iloprost on Pulmonary Oxygenation in Patients With Low Diffusing Capacity During One-lung Ventilation

One lung ventilation (OLV) is essential during thoracic surgery. During OLV, intrapulmonary shunt can be increased resulting hypoxemia. Although OLV technique had been advanced so far, hypoxemia during OLV reaches about 10% in spite of inspired oxygen fraction 100%. Iloprost is a prostaglandin analogue used for pulmonary hypertension, which can decrease pulmonary artery resistance by selectively dilating pulmonary artery. In this prospective, randomized, double blind study, investigators are planning to investigate the effects of iloprost on respiratory physiology (intrapulmonary shunt, deadspace, oxygenation, etc).

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Key information

Conditions

Lung Cancer Lung Diseases Lung Neoplasms Neoplasms Neoplasms by Site Respiratory Tract Diseases Respiratory Tract Neoplasms Thoracic Neoplasms

Age range

40 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Anaesthesiology and Pain Medicine, Anaesthesia and Pain Research Institute, Yonsei University College of Medicine

Seoul, 03722, South Korea

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

scheduled for Video-assisted thoracoscopic surgery (VATS) lobectomy
40 < age < 80
American Society of Anaesthesiologists (ASA) physical status classification I~III
diffusing capacity (DLCO) <75% at pre op. pulmonary function test

Exclusion criteria

American Society of Anaesthesiologists (ASA) physical status classification IV
New York Heart Association (NYHA) class III~IV
Severe obstructive lung disease and/or restrictive lung disease patients
patients with end-organ diseases (i.e. heart failure, respiratory failure, hepatic failure, renal failure)
arrhythmia
pregnant women
disease that can influence the DLCO result (anemia, pulmonary vascular disease)

Treatment and study plan

ILOPROST

Drug

20μg(2ml) of inhaled iloprost (Ventavis®)

When anesthesia induction finishes, change patients' position from supine to lateral position and measure arterial blood gas analysis (ABGA), venous blood gas analysis (VBGA) while two lung is ventilated. After 20 minutes of applying one lung ventilation, measure ABGA. Apply iloprost or normal saline inhalation for each iloprost and control group and measure ABGA at the time of 20 min and 40 min after iloprost (or normal saline) inhalation has finished.

normal saline

Drug

20μg(2ml) of inhaled normal saline

When anesthesia induction finishes, change patients' position from supine to lateral position and measure ABGA, VBGA while two lung is ventilated. After 20 minutes of applying one lung ventilation, measure ABGA. Apply iloprost or normal saline inhalation for each iloprost and control group and measure ABGA at the time of 20 min and 40 min after iloprost (or normal saline) inhalation has finished.

Primary outcomes

PaO2(partial pressure of arterial oxygen) ratio

Time frame: 40 minutes after iloprost inhalation
incidence of intrapulmonary shunt

Time frame: 40 minutes after iloprost inhalation

Sponsors and collaborators

Lead sponsor

Yonsei University

Other

Registry information

Important dates

Study start: 2015
Primary completion: 2017
Study completion: 2017
First posted: May 27, 2016
Registry last updated: Jun 20, 2018

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.

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

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