Lung CancerNCT03936140
The Effect of Iloprost on Oxygenation During One-lung Ventilation for Lung Surgery
A study testing Inhaled iloprost and Distilled water in people with Lung Cancer, run by Seoul St. Mary's Hospital at 1 site in South Korea.
Trial summary
During one-lung ventilation in patients undergoing thoracic surgery, the persistent flow in the non-ventilated lung increases intrapulmonary shunt and decreases systemic arterial oxygenation. Read more about this study
- Who is it for?
- Ages 20 to 75 years
- Conditions the study is for
- Lung Cancer
- What is being tested?
- Inhaled iloprost and Distilled water
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 72 participants
- Where
- 1 siteSouth Korea
- Study dates
- 4 Jan 2018to 24 Oct 2018
- 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 20 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- elective video-assisted thoracoscopic surgery (VATS) lobectomy
- 20 < age < 75
- American Society of Anesthesiologists (ASA) classification I~III
Who cannot join
- ASA classification IV
- New York Heart Association (NYHA) class III~IV
- Severe obstructive lung disease / restrictive lung disease
- Pulmonary hypertension
- End-stage organ disease (i.e. hepatic failure, renal failure)
- Arrhythmia
- Previous history of thoracic surgery
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Iloprost on Arterial Oxygenation and Shunt Fraction During One-lung Ventilation for Lung Surgery
During one-lung ventilation in patients undergoing thoracic surgery, the persistent flow in the non-ventilated lung increases intrapulmonary shunt and decreases systemic arterial oxygenation. This prospective, randomized, double blind study was conducted to evaluate the effects of inhaled iloprost during one-lung ventilation on arterial oxygenation and shunt fraction during thoracic surgery.
- Conditions
- Lung Cancer
- Being tested
- Inhaled iloprost, Distilled water
- Medical subject headings
- Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Inhaled iloprostDrug
Study drug was inhaled to ventilated lung through a nebulized system in inspiratory limb after one-lung ventilation in the lateral decubitus position.
Distilled waterDrug
Study drug was inhaled to ventilated lung through a nebulized system in inspiratory limb after one-lung ventilation in the lateral decubitus position.
| Study group | Role | What they receive |
|---|---|---|
| Iloprost 10 | Experimental | Iloprost 10μg of inhaled iloprost (Ventavis®)
Study drug was inhaled to ventilated lung through a nebulized system in inspiratory limb after one-lung ventilation in the lateral decubitus position. Receives: Drug: Inhaled iloprost |
| Iloprost 20 | Experimental | Iloprost 20μg of inhaled iloprost (Ventavis®)
Study drug was inhaled to ventilated lung through a nebulized system in inspiratory limb after one-lung ventilation in the lateral decubitus position. Receives: Drug: Inhaled iloprost |
| Distilled water | Placebo comparator | Distilled water
Study drug was inhaled to ventilated lung through a nebulized system in inspiratory limb after one-lung ventilation in the lateral decubitus position. Receives: Drug: Distilled water |
What is being measured
The primary outcome is the main question the study is designed to answer.
PaO2(partial pressure of arterial oxygen)
ABGA
Measured: 30 min after treatment
Pulmonary shunt fraction
Qs/Qt = (CcO2-CaO2) / (CcO2-CvO2)
Measured: 30 min after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 May 2019
- Study start4 Jan 2018
- Primary completion24 Oct 2018
- Study completion24 Oct 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung CancerStudies of the same condition, open and under way.
- 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
- 72 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seoul St. Mary's Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- The Catholic University of Korea
- Responsible party
- Principal investigator, Wonjung Hwang, Seoul St. Mary's Hospital
- Investigators
- Wonjung Hwang, Principal investigator, Seoul St. Mary's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03936140
- Sponsor's protocol ID
- KC14MISI0880
- Status last verified
- May 2019
- First submitted
- 8 Apr 2019
- Last updated
- 3 May 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 3 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Iloprost on Arterial Oxygenation and Shunt Fraction During One-lung Ventilation for Lung Surgery
- ClinicalTrials.gov ID
- NCT03936140
- Acronym / sponsor ID
- KC14MISI0880
- Conditions
- Lung Cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 72 participants (actual)
- Lead sponsor
- Seoul St. Mary's HospitalUniversity, hospital or other
- Collaborators
- The Catholic University of Korea
- Study start
- 4 Jan 2018 (actual)
- Primary completion
- 24 Oct 2018 (actual)
- Study completion
- 24 Oct 2018 (actual)
- First posted
- 3 May 2019 (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.
During one-lung ventilation in patients undergoing thoracic surgery, the persistent flow in the non-ventilated lung increases intrapulmonary shunt and decreases systemic arterial oxygenation. This prospective, randomized, double blind study was conducted to evaluate the effects of inhaled iloprost during one-lung ventilation on arterial oxygenation and shunt fraction during thoracic surgery.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Iloprost 10 | Experimental | Drug: Inhaled iloprostIloprost 10μg of inhaled iloprost (Ventavis®) Study drug was inhaled to ventilated lung through a nebulized system in inspiratory limb after one-lung ventilation in the lateral decubitus position. |
| Iloprost 20 | Experimental | Drug: Inhaled iloprostIloprost 20μg of inhaled iloprost (Ventavis®) Study drug was inhaled to ventilated lung through a nebulized system in inspiratory limb after one-lung ventilation in the lateral decubitus position. |
| Distilled water | Placebo comparator | Drug: Distilled waterDistilled water Study drug was inhaled to ventilated lung through a nebulized system in inspiratory limb after one-lung ventilation in the lateral decubitus position. |
Who may qualify
- Ages
- 20 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- elective video-assisted thoracoscopic surgery (VATS) lobectomy
- 20 < age < 75
- American Society of Anesthesiologists (ASA) classification I~III
Key exclusion criteria (7 listed)
- ASA classification IV
- New York Heart Association (NYHA) class III~IV
- Severe obstructive lung disease / restrictive lung disease
- Pulmonary hypertension
- End-stage organ disease (i.e. hepatic failure, renal failure)
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 |
|---|---|---|
| Inhaled iloprostStudy drug was inhaled to ventilated lung through a nebulized system in inspiratory limb after one-lung ventilation in the lateral decubitus position. | Drug | Iloprost 10, Iloprost 20 |
| Distilled waterStudy drug was inhaled to ventilated lung through a nebulized system in inspiratory limb after one-lung ventilation in the lateral decubitus position. | Drug | Distilled water |
Primary outcome
PaO2(partial pressure of arterial oxygen)
Time frame: 30 min after treatment
ABGA
Pulmonary shunt fraction
Time frame: 30 min after treatment
Qs/Qt = (CcO2-CaO2) / (CcO2-CvO2)
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 3 May 2019.
- Individual participant dataSharing planned: Undecided
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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.
Wonjung Hwang principal investigator
Seoul St. Mary's 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 Inhaled iloprost and Distilled water in people with Lung Cancer, run by Seoul St. Mary's Hospital 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 3 inclusion and 7 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 3 May 2019. 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?
PaO2(partial pressure of arterial oxygen) (time frame: 30 min after treatment). The study lists 2 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 3 May 2019.