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

NCT ID: NCT04927039

Last Updated: 2021-06-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-06-24

Study Completion Date

2023-06-30

Brief Summary

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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

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Conditions

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Mediastinal Mass

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Control group

Group Type PLACEBO_COMPARATOR

5ml of inhaled normal saline

Intervention Type DRUG

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.

Iloprost group

Group Type EXPERIMENTAL

20μg (2ml) of inhaled iloprost (Ventavis®) and 3ml of inhaled normal saline

Intervention Type DRUG

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.

Interventions

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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.

Intervention Type 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.

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Yonsei University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Kyuho Lee

Role: PRINCIPAL_INVESTIGATOR

Department of Anesthesiology and Pain Medicine, Severance Hospital, Yonsei University Health System

Locations

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Severance Hospital, Yonsei University Health System

Seoul, , South Korea

Site Status

Countries

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South Korea

Central Contacts

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Kyuho Lee

Role: CONTACT

82-2-2224-1636

Facility Contacts

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Kyuho Lee

Role: primary

82-2-2224-1636

Other Identifiers

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4-2021-0465

Identifier Type: -

Identifier Source: org_study_id

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