Clinical trial NCT02748265: Nebulized Epoprostenol (FLOLAN) and Phenylephrine on One Lung Ventilation (OLV)
Official title: A Pilot Study of the Effects of Nebulized Epoprostenol (Flolan) and Systemic Phenylephrine on Arterial Oxygenation During One Lung Ventilation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Oxygenation During One Lung Ventilation
Lead sponsor: University Health Network, Toronto
Sponsor class: OTHER
First posted: 2016-04-22
Enrollment: 8
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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) or with intravenous anesthesia (Propofol).


Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Increase of arterial oxygen tension in mmHg, during one-lung ventilation surgery, in response to combined nebulized epoprostenol/phenylephrine treatment
timeFrame: 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:
measure: Changes in base status in pH
timeFrame: Changes measured during surgery, from start of treatment at 30 minutes after one-lung ventilation (T30) to end of the 30 minutes treatment (T60).
measure: 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
timeFrame: Changes measured during surgery, from start of treatment at 30 minutes after one-lung ventilation (T30) to end of the 30 minutes treatment (T60).
measure: Changes in mean arterial blood pressure in mmHg
timeFrame: Changes measured during surgery, from start of treatment at 30 minutes after one-lung ventilation (T30) to end of the 30 minutes treatment (T60).
measure: Changes in platelet function count
timeFrame: Changes measured during surgery, from start of treatment at 30 minutes after one-lung ventilation (T30) to end of the 30 minutes treatment (T60).
measure: Changes in acid status in pH
timeFrame: Changes measured during surgery, from start of treatment at 30 minutes after one-lung ventilation (T30) to end of the 30 minutes treatment (T60).
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: Toronto General Hospital, 200 Elizabeth St.
state: Ontario
Study officials:
References: