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

Not Applicable

• Conditions: Mediastinal Mass
• Interventions: Drug: 5ml of inhaled normal saline; Drug: 20μg (2ml) of inhaled iloprost (Ventavis®) and 3ml of inhaled normal saline

• Registration Number: NCT04927039
• Lead Sponsor: Yonsei University

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2021-06
• Study First Submitted: 2021-06-09
• Study First Submitted QC: 2021-06-09
• Last Update Submitted: 2021-06-09
• Study First Posted: 2021-06-15
• Last Update Posted: 2021-06-15
• Study Start: 2021-06-24
• Primary Completion: 2023-06
• Study Completion: 2023-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 60

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control group	5ml of inhaled normal saline	-
Iloprost group	20μg (2ml) of inhaled iloprost (Ventavis®) and 3ml of inhaled normal saline	-

Primary Outcome Measures

Name	Time	Method
PaO2 (partial pressure of arterial oxygen) to FiO2 (fraction of inspired oxygen) ratio (P/F ratio)	Twenty minutes after the completion of drug inhalation	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.

Trial Locations

Locations (1)

Severance Hospital, Yonsei University Health System; 🇰🇷 Seoul, Korea, Republic of