Mediastinal MassNCT04927039
Effects of Iloprost on Oxygenation During One-lung Ventilation in Supine-positioned Patients
A study testing 5ml of inhaled normal saline and 20μg (2ml) of inhaled iloprost (Ventavis®) and 3ml of inhaled normal saline in people with Mediastinal Mass, run by Yonsei University at 1 site in South Korea.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 80 years
- Conditions the study is for
- Mediastinal Mass
- What is being tested?
- 5ml of inhaled normal saline and 20μg (2ml) of inhaled iloprost (Ventavis®) and 3ml of inhaled normal saline
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteSouth Korea
- Study dates
- 24 Jun 2021to Jun 2023
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Severance Hospital, Yonsei University Health System
Seoul
Kyuho Lee, 82-2-2224-1636, theoneimlee@yuhs.ac
About this study
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
- Being tested
- 5ml of inhaled normal saline, 20μg (2ml) of inhaled iloprost (Ventavis®) and 3ml of inhaled normal saline
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
5ml of inhaled normal salineDrug
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.
20μg (2ml) of inhaled iloprost (Ventavis®) and 3ml of inhaled normal salineDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| Control group | Placebo comparator | Not described Receives: Drug: 5ml of inhaled normal saline |
| Iloprost group | Experimental | Not described Receives: Drug: 20μg (2ml) of inhaled iloprost (Ventavis®) and 3ml of inhaled normal saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Twenty minutes after the completion of drug inhalation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jun 2021
- Study start24 Jun 2021 (estimated)
- Primary completionJun 2023 (estimated)
- Study completionJun 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mediastinal MassStudies 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
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Yonsei University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Kyuho Lee, Principal investigator, Department of Anesthesiology and Pain Medicine, Severance Hospital, Yonsei University Health System
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04927039
- Sponsor's protocol ID
- 4-2021-0465
- Status last verified
- Jun 2021
- First submitted
- 9 Jun 2021
- Last updated
- 15 Jun 2021
- 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 15 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Iloprost on Oxygenation During One-lung Ventilation in Supine-positioned Patients
- ClinicalTrials.gov ID
- NCT04927039
- Acronym / sponsor ID
- 4-2021-0465
- Conditions
- Mediastinal Mass
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Yonsei UniversityUniversity, hospital or other
- Study start
- 24 Jun 2021 (estimated)
- Primary completion
- Jun 2023 (estimated)
- Study completion
- Jun 2023 (estimated)
- First posted
- 15 Jun 2021 (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 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (12 listed)
- 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
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 |
|---|---|---|
| 5ml of inhaled normal salineAfter 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. | Drug | Control group |
| 20μg (2ml) of inhaled iloprost (Ventavis®) and 3ml of inhaled normal salineAfter 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. | Drug | Iloprost group |
Primary outcome
PaO2 (partial pressure of arterial oxygen) to FiO2 (fraction of inspired oxygen) ratio (P/F ratio)
Time frame: Twenty minutes after the completion of drug inhalation
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jun 2021.
- Individual participant dataSharing planned: No
Related trials for Mediastinal Mass
Enrolling by invitationObservational study
Difficult Airway Management in Oncology: An International Delphi Consensus Study (DAMO)
Neoplasms, Airway Obstruction Upper
Not yet recruiting
Effect of End-inspiratory Pause on Gas Exchange During Mediastinal Mass Excision With CO2 Insufflation and One-lung Ventilation
Mediastinal Mass Requiring Video-assisted Surgical Excision
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.
Kyuho Lee principal investigator
Department of Anesthesiology and Pain Medicine, Severance Hospital, Yonsei University Health System
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 5ml of inhaled normal saline and 20μg (2ml) of inhaled iloprost (Ventavis®) and 3ml of inhaled normal saline in people with Mediastinal Mass, 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 3 inclusion and 12 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: status not confirmed, as of the sponsor's last update on 15 Jun 2021. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Kyuho Lee (82-2-2224-1636, theoneimlee@yuhs.ac), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PaO2 (partial pressure of arterial oxygen) to FiO2 (fraction of inspired oxygen) ratio (P/F ratio) (time frame: Twenty minutes after the completion of drug inhalation). 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 15 Jun 2021.