NCT04583046

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
78

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Nov 2020

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 17, 2020

Completed
25 days until next milestone

First Posted

Study publicly available on registry

October 12, 2020

Completed
21 days until next milestone

Study Start

First participant enrolled

November 2, 2020

Completed
4.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 26, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 26, 2025

Completed
Last Updated

December 1, 2025

Status Verified

November 1, 2025

Enrollment Period

4.9 years

First QC Date

September 17, 2020

Last Update Submit

November 28, 2025

Conditions

Lung Cancer (Including Metastatic Cancer)Pulmonary Infection

Outcome Measures

Primary Outcomes (3)

  • Result of arterial blood gas analysis : partial pressure of oxygen(PaO2)

    20 minutes after iloprost inhalation (T2)

  • Result of arterial blood gas analysis : partial pressure of oxygen in the arterial blood(PaO2)/Fraction of inspired oxygen(FiO2) ratio (P/F ratio)

    20 minutes after iloprost inhalation (T2)

  • Result of arterial blood gas analysis : Oxygen saturation in arterial blood(SaO2)

    20 minutes after iloprost inhalation (T2)

Secondary Outcomes (2)

  • deadspace

    20 minutes after iloprost inhalation (T2)

  • intrapulmonary shunt

    20 minutes after iloprost inhalation (T2)

Study Arms (2)

placebo

PLACEBO COMPARATOR

normal saline inhalation group

Drug: normal saline inhalation

iloprost group

EXPERIMENTAL

iloprost inhalation group

Drug: iloprost inhalation

Interventions

normal saline inhalationDRUG

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).

placebo
iloprost inhalationDRUG

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).

iloprost group

Eligibility Criteria

Age40 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • scheduled for VATS lobectomy
  • \< age \< 80
  • American Society of Anaesthesiologists(ASA) physical status classification I\~III
  • BMI \> 30 kg /m2

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Severance Hospital

Seoul, South Korea

Location

MeSH Terms

Conditions

Lung Neoplasms

Condition Hierarchy (Ancestors)

Respiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract Diseases

Study Officials

  • Young Jun Oh

    Severance Hospital

    PRINCIPAL INVESTIGATOR

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

September 17, 2020

First Posted

October 12, 2020

Study Start

November 2, 2020

Primary Completion

September 26, 2025

Study Completion

September 26, 2025

Last Updated

December 1, 2025

Record last verified: 2025-11

Data Sharing

IPD Sharing
Will not share

Locations

KR(1)