NCT03936140

Brief Summary

During one-lung ventilation in patients undergoing thoracic surgery, the persistent flow in the non-ventilated lung increases intrapulmonary shunt and decreases systemic arterial oxygenation. This prospective, randomized, double blind study was conducted to evaluate the effects of inhaled iloprost during one-lung ventilation on arterial oxygenation and shunt fraction during thoracic surgery.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
72

participants targeted

Target at P25-P50 for not_applicable lung-cancer

Timeline
Completed

Started Jan 2018

Shorter than P25 for not_applicable lung-cancer

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

January 4, 2018

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 24, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 24, 2018

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

April 8, 2019

Completed
25 days until next milestone

First Posted

Study publicly available on registry

May 3, 2019

Completed
Last Updated

May 3, 2019

Status Verified

May 1, 2019

Enrollment Period

10 months

First QC Date

April 8, 2019

Last Update Submit

May 1, 2019

Conditions

Lung Cancer

Outcome Measures

Primary Outcomes (2)

  • PaO2(partial pressure of arterial oxygen)

    ABGA

    30 min after treatment

  • Pulmonary shunt fraction

    Qs/Qt = (CcO2-CaO2) / (CcO2-CvO2)

    30 min after treatment

Study Arms (3)

Iloprost 10

EXPERIMENTAL

Iloprost 10μg of inhaled iloprost (Ventavis®) Study drug was inhaled to ventilated lung through a nebulized system in inspiratory limb after one-lung ventilation in the lateral decubitus position.

Drug: Inhaled iloprost

Iloprost 20

EXPERIMENTAL

Iloprost 20μg of inhaled iloprost (Ventavis®) Study drug was inhaled to ventilated lung through a nebulized system in inspiratory limb after one-lung ventilation in the lateral decubitus position.

Drug: Inhaled iloprost

Distilled water

PLACEBO COMPARATOR

Distilled water Study drug was inhaled to ventilated lung through a nebulized system in inspiratory limb after one-lung ventilation in the lateral decubitus position.

Drug: Distilled water

Interventions

Inhaled iloprostDRUG

Study drug was inhaled to ventilated lung through a nebulized system in inspiratory limb after one-lung ventilation in the lateral decubitus position.

Iloprost 10Iloprost 20
Distilled waterDRUG

Study drug was inhaled to ventilated lung through a nebulized system in inspiratory limb after one-lung ventilation in the lateral decubitus position.

Distilled water

Eligibility Criteria

Age20 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • elective video-assisted thoracoscopic surgery (VATS) lobectomy
  • \< age \< 75
  • American Society of Anesthesiologists (ASA) classification I\~III

You may not qualify if:

  • ASA classification IV
  • New York Heart Association (NYHA) class III\~IV
  • Severe obstructive lung disease / restrictive lung disease
  • Pulmonary hypertension
  • End-stage organ disease (i.e. hepatic failure, renal failure)
  • Arrhythmia
  • Previous history of thoracic surgery

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Seoul St.Mary's Hospital

Seoul, South Korea

Location

MeSH Terms

Conditions

Lung Neoplasms

Condition Hierarchy (Ancestors)

Respiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract Diseases

Study Officials

  • Wonjung Hwang

    Seoul St. Mary's Hospital

    PRINCIPAL INVESTIGATOR

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
PRINCIPAL INVESTIGATOR
PI Title
Assistant professor

Study Record Dates

First Submitted

April 8, 2019

First Posted

May 3, 2019

Study Start

January 4, 2018

Primary Completion

October 24, 2018

Study Completion

October 24, 2018

Last Updated

May 3, 2019

Record last verified: 2019-05

Locations

KR(1)