Effects of Iloprost on Oxygenation During One-lung Ventilation in Supine-positioned Patients

One-lung ventilation (OLV) is essential during mediastinal mass excision. However, OLV induces a drastic increase of intrapulmonary shunt due to maintained pulmonary perfusion through the nonventilated lung. In addition, it is reported that supine positioning of patient during OLV, which is required during mediastinal mass excision, results in worse oxygenation than lateral decubitus positioning.

Iloprost is a prostaglandin analogue and when inhaled during OLV, it acts selectively on the pulmonary vasculature, reducing pulmonary vascular resistance of well-ventilated lung and thereby alleviating ventilation-perfusion mismatch. The purpose of this study is to evaluate the effects of inhaled iloprost on oxygenation during one-lung ventilation in patients undergoing mediastinal mass excision.

Study Overview

• Status: Not yet recruiting
• Conditions: Mediastinal Mass
• Intervention / Treatment: Drug: 5ml of inhaled normal saline; Drug: 20μg (2ml) of inhaled iloprost (Ventavis®) and 3ml of inhaled normal saline

• Study Type: Interventional
• Enrollment (Anticipated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Kyuho Lee; Phone Number: 82-2-2224-1636; Email: theoneimlee@yuhs.ac

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of
    • Severance Hospital, Yonsei University Health System
    • Contact: Kyuho Lee; Phone Number: 82-2-2224-1636; Email: theoneimlee@yuhs.ac

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Patients scheduled for Video-assisted thoracoscopic surgery (VATS) mediastinal mass excision
2. Patient age from 20 to 80
3. American Society of Anaesthesiologists (ASA) physical status classification II~III

Exclusion Criteria:

1. Chronic obstructive pulmonary disease (COPD) with Forced expiratory volume in 1 second (FEV1) to Forced vital capacity (FVC) ratio < 0.7 and percentage of predicted FEV1 ≤ 80%
2. Diffusing capacity of carbon monoxide (DLCO) < 80%
3. Aspartate transaminase (AST) level ≥100 IU/mL or alanine transaminase (ALT) ≥ level 50 IU/L
4. Creatinine clearance ≤ 30mL/min
5. Congestive heart failure, arrhythmia
6. Unstable angina, coronary artery occlusive disease (CAOD), history of myocardial infarction within 6 months
7. Pulmonary edema, pulmonary arterial hypertension
8. Allergic to prostaglandin or prostacyclin analogue
9. Patients with peptic ulcer bleeding, trauma, intracranial hemorrhage
10. History of cerebrovascular disease (e.g. transient ischemic attack, stroke) within 3 months
11. Valvular heart disease
12. Pregnant women

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Control group	Drug: 5ml of inhaled normal saline; After the initiation of OLV, 5ml of normal saline is inhaled for 20 minutes using ultrasonic nebulizer, which is connected to the inspiratory limb of the ventilator system. Arterial blood gas analysis is performed 20 minutes after the completion of drug inhalation.
Experimental: Iloprost group	Drug: 20μg (2ml) of inhaled iloprost (Ventavis®) and 3ml of inhaled normal saline; After the initiation of OLV, mixture of iloprost 2ml and normal saline 3ml is inhaled for 20 minutes using ultrasonic nebulizer, which is connected to the inspiratory limb of the ventilator system. Arterial blood gas analysis is performed 20 minutes after the completion of drug inhalation.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
PaO2 (partial pressure of arterial oxygen) to FiO2 (fraction of inspired oxygen) ratio (P/F ratio)	The P/F ratio is a widely-used objective tool to identify hypoxemic respiratory failure when supplemental oxygen has been administered. It can be used to evaluate the effect of iloprost on oxygenation during OLV.	Twenty minutes after the completion of drug inhalation

Collaborators and Investigators

• Sponsor: Yonsei University
• Investigators: Principal Investigator: Kyuho Lee, Department of Anesthesiology and Pain Medicine, Severance Hospital, Yonsei University Health System

Study record dates

Study Major Dates

• Study Start (Anticipated): June 24, 2021
• Primary Completion (Anticipated): June 1, 2023
• Study Completion (Anticipated): June 1, 2023

Study Registration Dates

• First Submitted: June 9, 2021
• First Submitted That Met QC Criteria: June 9, 2021
• First Posted (Actual): June 15, 2021

Study Record Updates

• Last Update Posted (Actual): June 15, 2021
• Last Update Submitted That Met QC Criteria: June 9, 2021
• Last Verified: June 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Vasodilator Agents; Platelet Aggregation Inhibitors; Iloprost
• Other Study ID Numbers: 4-2021-0465

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No