Effects of Iloprost on Pulmonary Oxygenation in Obese Patients During One-lung Ventilation

NCT ID: NCT04583046

Last Updated: 2025-12-01

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

COMPLETED

Clinical Phase

NA

Total Enrollment

78 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-11-02

Study Completion Date

2025-09-26

Brief Summary

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One lung ventilation (OLV) is essential during thoracic surgery. During OLV, intrapulmonary shunt can be increased resulting hypoxemia. Although OLV technique had been advanced so far, hypoxemia during OLV reaches about 10% in spite of inspired oxygen fraction 100%. Iloprost is a prostaglandin analogue used for pulmonary hypertension, which can decrease pulmonary artery resistance by selectively dilating pulmonary artery. In this prospective, randomized, double blind study, the investigator is planning to investigate the effects of iloprost on respiratory physiology (intrapulmonary shunt, deadspace, oxygenation, etc) in obese patients.

Detailed Description

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Conditions

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Lung Cancer (Including Metastatic Cancer) Pulmonary Infection

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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placebo

normal saline inhalation group

Group Type PLACEBO_COMPARATOR

normal saline inhalation

Intervention Type DRUG

When anesthesia induction finishes, change patients' position from supine to lateral position and measure ABGA, VBGA while two lung is ventilated (T0). After 20 minutes of applying one-lung ventilation, measure ABGA and VBGA (T1). Apply normal saline inhalation for control group and measure ABGA at the time of 20 min after normal saline inhalation has finished (T2).

iloprost group

iloprost inhalation group

Group Type EXPERIMENTAL

iloprost inhalation

Intervention Type DRUG

When anesthesia induction finishes, change patients' position from supine to lateral position and measure ABGA, VBGA while two lung is ventilated (T0). After 20 minutes of applying one-lung ventilation, measure ABGA and VBGA (T1). Apply iloprost inhalation for iloprost group and measure ABGA at the time of 20 min after iloprost inhalation has finished (T2).

Interventions

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normal saline inhalation

When anesthesia induction finishes, change patients' position from supine to lateral position and measure ABGA, VBGA while two lung is ventilated (T0). After 20 minutes of applying one-lung ventilation, measure ABGA and VBGA (T1). Apply normal saline inhalation for control group and measure ABGA at the time of 20 min after normal saline inhalation has finished (T2).

Intervention Type DRUG

iloprost inhalation

When anesthesia induction finishes, change patients' position from supine to lateral position and measure ABGA, VBGA while two lung is ventilated (T0). After 20 minutes of applying one-lung ventilation, measure ABGA and VBGA (T1). Apply iloprost inhalation for iloprost group and measure ABGA at the time of 20 min after iloprost inhalation has finished (T2).

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

1. scheduled for VATS lobectomy
2. 40 \< age \< 80
3. American Society of Anaesthesiologists(ASA) physical status classification I\~III
4. BMI \> 30 kg /m2

Exclusion Criteria

1. American Society of Anaesthesiologists(ASA) physical status classification IV or more
2. NYHA class III\~IV
3. Severe obstructive lung disease and/or restrictive lung disease patients
4. patients with end-organ diseases (i.e. heart failure, respiratory failure, hepatic failure, renal failure)
5. arrhythmia
6. pregnant women
7. pulmonary edema or pulmonary arterial hypertension
8. cerebrovascular disease
9. unstable angina or myocardial infarction within 6 months
10. patients with allergic reaction at iloprost
Minimum Eligible Age

40 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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Young Jun Oh

Role: PRINCIPAL_INVESTIGATOR

Severance Hospital

Locations

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Severance Hospital

Seoul, , South Korea

Site Status

Countries

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South Korea

Other Identifiers

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4-2020-0722

Identifier Type: -

Identifier Source: org_study_id

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