Oxygenation During One Lung VentilationPhase 4FLOLANNCT02748265
Nebulized Epoprostenol (FLOLAN) and Phenylephrine on One Lung Ventilation (OLV)
A Phase 4 study testing Inhaled Epoprostenol and phenylephrine, Sevoflurane and Propofol in people with Oxygenation During One Lung Ventilation, run by University Health Network, Toronto at 1 site in Canada.
Trial summary
This is a pilot study of a new use of Epoprostenol via inhalation (Epoprostenol is approved for intravenous use). The purpose of this study is to administered inhaled Epoprostenol and intravenous Phenylephrine to improve arterial oxygen tension during one-lung anesthesia either with volatile anesthesia (Sevoflurane)… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Oxygenation During One Lung Ventilation
- What is being tested?
- Inhaled Epoprostenol and phenylephrine, Sevoflurane and Propofol
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 1 siteCanada
- Study dates
- Mar 2016to 31 Dec 2018
- Phase
- Phase 4
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients undergoing esophagectomy via video assisted thoracoscopy surgery or open thoracotomy.
- Patients greater than eighteen years old that have the capacity to provide consent.
- Patients who weigh 89kg or less.
- Patients with a preoperative platelet count > 100,000mm3
Who cannot join
- Contraindication or allergy to any of the study drugs e.g. epoprostenol, phenylephrine, sevoflurane or propofol.
- Spirometry: Force expiratory Volume (FEV1) less than 80% predicted for age. Patients with spirometry indicative of obstructive lung disease are less likely to develop hypoxemia during OLV compared to patients with normal spirometry . These patients are likely to have a smaller treatment effect if any.
- A history of a bleeding diathesis.
- Use of a platelet inhibitor within the last seven days e.g. Aspirin, clopidogrel
Trial locations and contacts
1 site in 1 country.
Canada1 site
Toronto General Hospital, 200 Elizabeth St.
Toronto, Ontario, B3H 1V7
About this study
Official title: A Pilot Study of the Effects of Nebulized Epoprostenol (Flolan) and Systemic Phenylephrine on Arterial Oxygenation During One Lung Ventilation
This is a pilot study of a new use of Epoprostenol via inhalation (Epoprostenol is approved for intravenous use). The purpose of this study is to administered inhaled Epoprostenol and intravenous Phenylephrine to improve arterial oxygen tension during one-lung anesthesia either with volatile anesthesia (Sevoflurane) or with intravenous anesthesia (Propofol).
- Conditions
- Oxygenation During One Lung Ventilation
- Being tested
- Inhaled Epoprostenol and phenylephrine, Sevoflurane, Propofol
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Inhaled Epoprostenol and phenylephrineDrug
Also called Prostacyclin
After 30 minutes of one-lung ventilation, Epoprostenol 50 ng/kg/min is administered via nebuliser in the anesthesia circuit with phenylephrine administered intravenously
SevofluraneDrug
Volatile maintenance anesthesia
PropofolDrug
Intravenous maintenance anesthesia
| Study group | Role | What they receive |
|---|---|---|
| Inhaled Epoprostenol, phenylephrine, sevoflurane | Other | Inhaled Epoprostenol (Flolan), phenylephrine, volatile anesthesia maintenance (Sevoflurane) Receives: Drug: Inhaled Epoprostenol and phenylephrine; Drug: Sevoflurane |
| Inhaled Epoprostenol phenylephrine & Propofol | Other | Inhaled Epoprostenol (Flolan), phenylephrine and intravenous anesthesia maintenance (Propofol) Receives: Drug: Inhaled Epoprostenol and phenylephrine; Drug: Propofol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Increase of arterial oxygen tension in mmHg, during one-lung ventilation surgery, in response to combined nebulized epoprostenol/phenylephrine treatment
Measured: Changes measured during surgery, from start of treatment at 30 minutes after one-lung ventilation (T30) to end of the 30 minutes treatment (T60).
Secondary outcomes (5)
Changes in base status in pH
Measured: Changes measured during surgery, from start of treatment at 30 minutes after one-lung ventilation (T30) to end of the 30 minutes treatment (T60).
Differences between anesthetic technique -volatile vs. intravenous- in increase of arterial oxygen tension in mmHg, during one-lung ventilation surgery, in response to combined nebulized epoprostenol/phenylephrine treatment
Measured: Changes measured during surgery, from start of treatment at 30 minutes after one-lung ventilation (T30) to end of the 30 minutes treatment (T60).
Changes in mean arterial blood pressure in mmHg
Measured: Changes measured during surgery, from start of treatment at 30 minutes after one-lung ventilation (T30) to end of the 30 minutes treatment (T60).
Changes in platelet function count
Measured: Changes measured during surgery, from start of treatment at 30 minutes after one-lung ventilation (T30) to end of the 30 minutes treatment (T60).
Changes in acid status in pH
Measured: Changes measured during surgery, from start of treatment at 30 minutes after one-lung ventilation (T30) to end of the 30 minutes treatment (T60).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2016 (estimated)
- Study startMar 2016
- Primary completion30 Jul 2017
- Study completion31 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Oxygenation During One Lung VentilationStudies of the same condition, open and under way.
- More trials run by University Health Network, TorontoThe 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 4
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Health Network, Toronto
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02748265
- Sponsor's protocol ID
- 14-7520
- Acronym
- FLOLAN
- Status last verified
- May 2019
- First submitted
- 23 Mar 2016
- Last updated
- 17 May 2019
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study of the Effects of Nebulized Epoprostenol (Flolan) and Systemic Phenylephrine on Arterial Oxygenation During One Lung Ventilation
- ClinicalTrials.gov ID
- NCT02748265
- Acronym / sponsor ID
- FLOLAN / 14-7520
- Conditions
- Oxygenation During One Lung Ventilation
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 8 participants (actual)
- Lead sponsor
- University Health Network, TorontoUniversity, hospital or other
- Study start
- Mar 2016 (actual)
- Primary completion
- 30 Jul 2017 (actual)
- Study completion
- 31 Dec 2018 (actual)
- First posted
- 22 Apr 2016 (estimated)
- 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.
This is a pilot study of a new use of Epoprostenol via inhalation (Epoprostenol is approved for intravenous use). The purpose of this study is to administered inhaled Epoprostenol and intravenous Phenylephrine to improve arterial oxygen tension during one-lung anesthesia either with volatile anesthesia (Sevoflurane) or with intravenous anesthesia (Propofol).
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Inhaled Epoprostenol, phenylephrine, sevoflurane | Other | Drug: Inhaled Epoprostenol and phenylephrine, Drug: SevofluraneInhaled Epoprostenol (Flolan), phenylephrine, volatile anesthesia maintenance (Sevoflurane) |
| Inhaled Epoprostenol phenylephrine & Propofol | Other | Drug: Inhaled Epoprostenol and phenylephrine, Drug: PropofolInhaled Epoprostenol (Flolan), phenylephrine and intravenous anesthesia maintenance (Propofol) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients undergoing esophagectomy via video assisted thoracoscopy surgery or open thoracotomy.
- Patients greater than eighteen years old that have the capacity to provide consent.
- Patients who weigh 89kg or less.
- Patients with a preoperative platelet count > 100,000mm3
Key exclusion criteria (4 listed)
- Contraindication or allergy to any of the study drugs e.g. epoprostenol, phenylephrine, sevoflurane or propofol.
- Spirometry: Force expiratory Volume (FEV1) less than 80% predicted for age. Patients with spirometry indicative of obstructive lung disease are less likely to develop hypoxemia during OLV compared to patients with normal spirometry . These patients are likely to have a smaller treatment effect if any.
- A history of a bleeding diathesis.
- Use of a platelet inhibitor within the last seven days e.g. Aspirin, clopidogrel
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 Epoprostenol and phenylephrineAlso: ProstacyclinAfter 30 minutes of one-lung ventilation, Epoprostenol 50 ng/kg/min is administered via nebuliser in the anesthesia circuit with phenylephrine administered intravenously | Drug | Inhaled Epoprostenol phenylephrine & Propofol, Inhaled Epoprostenol, phenylephrine, sevoflurane |
| SevofluraneVolatile maintenance anesthesia | Drug | Inhaled Epoprostenol, phenylephrine, sevoflurane |
| PropofolIntravenous maintenance anesthesia | Drug | Inhaled Epoprostenol phenylephrine & Propofol |
Primary outcome
Increase of arterial oxygen tension in mmHg, during one-lung ventilation surgery, in response to combined nebulized epoprostenol/phenylephrine treatment
Time frame: Changes measured during surgery, from start of treatment at 30 minutes after one-lung ventilation (T30) to end of the 30 minutes treatment (T60).
5 secondary outcomes
Changes in base status in pH
Time frame: Changes measured during surgery, from start of treatment at 30 minutes after one-lung ventilation (T30) to end of the 30 minutes treatment (T60).
Differences between anesthetic technique -volatile vs. intravenous- in increase of arterial oxygen tension in mmHg, during one-lung ventilation surgery, in response to combined nebulized epoprostenol/phenylephrine treatment
Time frame: Changes measured during surgery, from start of treatment at 30 minutes after one-lung ventilation (T30) to end of the 30 minutes treatment (T60).
Changes in mean arterial blood pressure in mmHg
Time frame: Changes measured during surgery, from start of treatment at 30 minutes after one-lung ventilation (T30) to end of the 30 minutes treatment (T60).
Changes in platelet function count
Time frame: Changes measured during surgery, from start of treatment at 30 minutes after one-lung ventilation (T30) to end of the 30 minutes treatment (T60).
Changes in acid status in pH
Time frame: Changes measured during surgery, from start of treatment at 30 minutes after one-lung ventilation (T30) to end of the 30 minutes treatment (T60).
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 17 May 2019.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Inhaled Epoprostenol and phenylephrine, Sevoflurane and Propofol in people with Oxygenation During One Lung Ventilation, run by University Health Network, Toronto at 1 site in Canada.
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 4 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 17 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 Canada. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Increase of arterial oxygen tension in mmHg, during one-lung ventilation surgery, in response to combined nebulized epoprostenol/phenylephrine treatment (time frame: Changes measured during surgery, from start of treatment at 30 minutes after one-lung ventilation (T30) to end of the 30 minutes treatment (T60).). 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 17 May 2019.