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

Sponsor

Yonsei University (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT04927039

Collaborator

(none)

Enrollment

Location

Arms

23.2

Anticipated Duration (Months)

2.6

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Mediastinal Mass	Drug: 5ml of inhaled normal saline Drug: 20μg (2ml) of inhaled iloprost (Ventavis®) and 3ml of inhaled normal saline	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

60 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Investigator)

Primary Purpose:

Treatment

Official Title:

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

Anticipated Study Start Date :

Jun 24, 2021

Anticipated Primary Completion Date :

Jun 1, 2023

Anticipated Study Completion Date :

Jun 1, 2023

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

20 Years to 80 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

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

Exclusion Criteria:

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%
Diffusing capacity of carbon monoxide (DLCO) < 80%
Aspartate transaminase (AST) level ≥100 IU/mL or alanine transaminase (ALT) ≥ level 50 IU/L
Creatinine clearance ≤ 30mL/min
Congestive heart failure, arrhythmia
Unstable angina, coronary artery occlusive disease (CAOD), history of myocardial infarction within 6 months
Pulmonary edema, pulmonary arterial hypertension
Allergic to prostaglandin or prostacyclin analogue
Patients with peptic ulcer bleeding, trauma, intracranial hemorrhage
History of cerebrovascular disease (e.g. transient ischemic attack, stroke) within 3 months
Valvular heart disease
Pregnant women

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Severance Hospital, Yonsei University Health System	Seoul		Korea, Republic of

Sponsors and Collaborators

Yonsei University

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Yonsei University

ClinicalTrials.gov Identifier:

NCT04927039

Other Study ID Numbers:

4-2021-0465

First Posted:

Jun 15, 2021

Last Update Posted:

Jun 15, 2021

Last Verified:

Jun 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Iloprost

Study Results

No Results Posted as of Jun 15, 2021