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

NCT04927039 | Unknown

• 1 other identifier: 4-2021-0465
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Mediastinal Mass

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Control group

PLACEBO COMPARATOR

Drug: 5ml of inhaled normal saline

Iloprost group

EXPERIMENTAL

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

Interventions

5ml of inhaled normal saline 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.

Control group

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

Iloprost group

Eligibility Criteria

• Age: 20 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Yonsei University: lead

Study Sites (1)

Severance Hospital, Yonsei University Health System

Seoul, South Korea

Location

MeSH Terms

Interventions

Iloprost

Intervention Hierarchy (Ancestors)

Prostaglandins, Synthetic; Prostaglandins; Eicosanoids; Fatty Acids, Unsaturated; Fatty Acids; Lipids; Autacoids; Inflammation Mediators; Biological Factors

Study Officials

• Kyuho Lee

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

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Kyuho Lee

CONTACT

82-2-2224-1636; theoneimlee@yuhs.ac

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 9, 2021
• First Posted: June 15, 2021
• Study Start: June 24, 2021
• Primary Completion: June 1, 2023
• Study Completion: June 1, 2023
• Last Updated: June 15, 2021

Record last verified: 2021-06

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)