Lung Cancer (Including Metastatic Cancer)NCT04583046
Effects of Iloprost on Pulmonary Oxygenation in Obese Patients During One-lung Ventilation
A study testing normal saline inhalation and iloprost inhalation in people with Lung Cancer (Including Metastatic Cancer) and Pulmonary Infection, run by Yonsei University at 1 site in South Korea.
Trial 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%. Read more about this study
- Who is it for?
- Ages 40 to 80 years
- Conditions the study is for
- Lung Cancer (Including Metastatic Cancer), Pulmonary Infection
- What is being tested?
- normal saline inhalation and iloprost inhalation
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 78 participants
- Where
- 1 siteSouth Korea
- Study dates
- 2 Nov 2020to 26 Sep 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- scheduled for VATS lobectomy
- 40 < age < 80
- American Society of Anaesthesiologists(ASA) physical status classification I~III
- BMI > 30 kg /m2
Who cannot join
- 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
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- pulmonary edema or pulmonary arterial hypertension
- cerebrovascular disease
- unstable angina or myocardial infarction within 6 months
- patients with allergic reaction at iloprost
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Being tested
- normal saline inhalation, iloprost inhalation
- Medical subject headings
- Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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).
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).
| Study group | Role | What they receive |
|---|---|---|
| placebo | Placebo comparator | normal saline inhalation group Receives: Drug: normal saline inhalation |
| iloprost group | Experimental | iloprost inhalation group Receives: Drug: iloprost inhalation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Result of arterial blood gas analysis : partial pressure of oxygen(PaO2)
Measured: 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)
Measured: 20 minutes after iloprost inhalation (T2)
Result of arterial blood gas analysis : Oxygen saturation in arterial blood(SaO2)
Measured: 20 minutes after iloprost inhalation (T2)
Secondary outcomes (2)
deadspace
Dead space ventilation was calculated with Paco2 and end-tidal carbon dioxide (Etco2) according to the Hardman and Aitkenhead equation [1.14 × (Paco2- Etco2)/Paco2 - 0.005].
Measured: 20 minutes after iloprost inhalation (T2)
intrapulmonary shunt
-Shunt fraction (Qs/Qt) was calculated using the following formula: Qs/Qt = (CcO2-CaO2)/(CcO2-CvO2), (1)
-whereby:
- CaO2 = (PaO2 x 0.0031) + (Hemoglobin x 1.36 x SaO2), (2)
- CvO2 = (PvO2 x 0.0031) + (Hemoglobin x 1.36 x SvO2), (3)
- CcO2 = ([FiO2 x (PB - PH2O) - PaCO2/Respiratory quotient] x 0.0031) + (Hemoglobin x 1.36), (4)
- PB is the barometric pressure (760 mmHg), the PH2O is 47 mmHg
Measured: 20 minutes after iloprost inhalation (T2)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Oct 2020
- Study start2 Nov 2020
- Primary completion26 Sep 2025
- Study completion26 Sep 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung Cancer (Including Metastatic Cancer)Studies of the same condition, open and under way.
- More trials run by Yonsei UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 78 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yonsei University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Young Jun Oh, Principal investigator, Severance Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04583046
- Sponsor's protocol ID
- 4-2020-0722
- Status last verified
- Nov 2025
- First submitted
- 17 Sep 2020
- Last updated
- 1 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Iloprost on Pulmonary Oxygenation in Obese Patients During One-lung Ventilation
- ClinicalTrials.gov ID
- NCT04583046
- Acronym / sponsor ID
- 4-2020-0722
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 78 participants (actual)
- Lead sponsor
- Yonsei UniversityUniversity, hospital or other
- Study start
- 2 Nov 2020 (actual)
- Primary completion
- 26 Sep 2025 (actual)
- Study completion
- 26 Sep 2025 (actual)
- First posted
- 12 Oct 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| placebo | Placebo comparator | Drug: normal saline inhalationnormal saline inhalation group |
| iloprost group | Experimental | Drug: iloprost inhalationiloprost inhalation group |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- scheduled for VATS lobectomy
- 40 < age < 80
- American Society of Anaesthesiologists(ASA) physical status classification I~III
- BMI > 30 kg /m2
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| normal saline inhalationWhen 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). | Drug | placebo |
| iloprost inhalationWhen 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). | Drug | iloprost group |
Primary outcome
Result of arterial blood gas analysis : partial pressure of oxygen(PaO2)
Time frame: 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)
Time frame: 20 minutes after iloprost inhalation (T2)
Result of arterial blood gas analysis : Oxygen saturation in arterial blood(SaO2)
Time frame: 20 minutes after iloprost inhalation (T2)
2 secondary outcomes
deadspace
Time frame: 20 minutes after iloprost inhalation (T2)
intrapulmonary shunt
Time frame: 20 minutes after iloprost inhalation (T2)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Dec 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Young Jun Oh principal investigator
Severance Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing normal saline inhalation and iloprost inhalation in people with Lung Cancer (Including Metastatic Cancer) and Pulmonary Infection, run by Yonsei University at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Result of arterial blood gas analysis : partial pressure of oxygen(PaO2) (time frame: 20 minutes after iloprost inhalation (T2)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Dec 2025; AzTrials last refreshed its copy on 8 Nov 2026.