NCT02784899

Brief 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%. 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, investigators are planning to investigate the effects of iloprost on respiratory physiology (intrapulmonary shunt, deadspace, oxygenation, etc).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable lung-cancer

Timeline
Completed

Started Oct 2015

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 8, 2015

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

May 16, 2016

Completed
11 days until next milestone

First Posted

Study publicly available on registry

May 27, 2016

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2017

Completed
Last Updated

June 20, 2018

Status Verified

June 1, 2018

Enrollment Period

1.7 years

First QC Date

May 16, 2016

Last Update Submit

June 19, 2018

Conditions

Lung Cancer

Outcome Measures

Primary Outcomes (2)

  • PaO2(partial pressure of arterial oxygen) ratio

    40 minutes after iloprost inhalation

  • incidence of intrapulmonary shunt

    40 minutes after iloprost inhalation

Study Arms (2)

iloprost group

EXPERIMENTAL

iloprost inhalation group

Drug: iloprost

control group

PLACEBO COMPARATOR

normal saline inhalation group

Drug: normal saline

Interventions

iloprostDRUG

20μg(2ml) of inhaled iloprost (Ventavis®) When anesthesia induction finishes, change patients' position from supine to lateral position and measure arterial blood gas analysis (ABGA), venous blood gas analysis (VBGA) while two lung is ventilated. After 20 minutes of applying one lung ventilation, measure ABGA. Apply iloprost or normal saline inhalation for each iloprost and control group and measure ABGA at the time of 20 min and 40 min after iloprost (or normal saline) inhalation has finished.

iloprost group
normal salineDRUG

20μg(2ml) of inhaled normal saline When anesthesia induction finishes, change patients' position from supine to lateral position and measure ABGA, VBGA while two lung is ventilated. After 20 minutes of applying one lung ventilation, measure ABGA. Apply iloprost or normal saline inhalation for each iloprost and control group and measure ABGA at the time of 20 min and 40 min after iloprost (or normal saline) inhalation has finished.

control group

Eligibility Criteria

Age40 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • scheduled for Video-assisted thoracoscopic surgery (VATS) lobectomy
  • \< age \< 80
  • American Society of Anaesthesiologists (ASA) physical status classification I\~III
  • diffusing capacity (DLCO) \<75% at pre op. pulmonary function test

You may not qualify if:

  • American Society of Anaesthesiologists (ASA) physical status classification IV
  • New York Heart Association (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
  • disease that can influence the DLCO result (anemia, pulmonary vascular disease)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Anaesthesiology and Pain Medicine, Anaesthesia and Pain Research Institute, Yonsei University College of Medicine

Seoul, 03722, South Korea

Location

MeSH Terms

Conditions

Lung Neoplasms

Interventions

IloprostSaline Solution

Condition Hierarchy (Ancestors)

Respiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Prostaglandins, SyntheticProstaglandinsEicosanoidsFatty Acids, UnsaturatedFatty AcidsLipidsAutacoidsInflammation MediatorsBiological FactorsCrystalloid SolutionsIsotonic SolutionsSolutionsPharmaceutical Preparations

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 16, 2016

First Posted

May 27, 2016

Study Start

October 8, 2015

Primary Completion

June 30, 2017

Study Completion

June 30, 2017

Last Updated

June 20, 2018

Record last verified: 2018-06

Data Sharing

IPD Sharing
Will not share

Locations

KR(1)