Effect of Iloprost on Pulmonary Oxygenation in Patients With Low Diffusing Capacity During One-lung Ventilation

June 19, 2018 updated by: Yonsei University
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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
      • Seoul, Korea, Republic of, 03722
        • Department of Anaesthesiology and Pain Medicine, Anaesthesia and Pain Research Institute, Yonsei University College of Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • 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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: iloprost group
iloprost inhalation group
Drug: iloprost

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.
Placebo Comparator: control group
normal saline inhalation group
Drug: normal saline

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
PaO2(partial pressure of arterial oxygen) ratio
Time Frame: 40 minutes after iloprost inhalation
40 minutes after iloprost inhalation
incidence of intrapulmonary shunt
Time Frame: 40 minutes after iloprost inhalation
40 minutes after iloprost inhalation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Yonsei University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 8, 2015

Primary Completion (Actual)

June 30, 2017

Study Completion (Actual)

June 30, 2017

Study Registration Dates

First Submitted

May 16, 2016

First Submitted That Met QC Criteria

May 24, 2016

First Posted (Estimate)

May 27, 2016

Study Record Updates

Last Update Posted (Actual)

June 20, 2018

Last Update Submitted That Met QC Criteria

June 19, 2018

Last Verified

June 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 4-2015-0706

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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