免费获得国外相关药品，最快 1 个工作日回馈药物信息

出境医 / 临床实验 / The Effect of Iloprost on Oxygenation During One-lung Ventilation for Lung Surgery

The Effect of Iloprost on Oxygenation During One-lung Ventilation for Lung Surgery

Study Description
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.

Condition or disease Intervention/treatment Phase
Lung Cancer Drug: Inhaled iloprost Drug: Distilled water Not Applicable

Study Design
Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 72 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: The Effect of Iloprost on Arterial Oxygenation and Shunt Fraction During One-lung Ventilation for Lung Surgery
Actual Study Start Date : January 4, 2018
Actual Primary Completion Date : October 24, 2018
Actual Study Completion Date : October 24, 2018
Arms and Interventions
Arm Intervention/treatment
Experimental: Iloprost 10

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
Study drug was inhaled to ventilated lung through a nebulized system in inspiratory limb after one-lung ventilation in the lateral decubitus position.
Experimental: Iloprost 20

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

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
Study drug was inhaled to ventilated lung through a nebulized system in inspiratory limb after one-lung ventilation in the lateral decubitus position.
Outcome Measures
Primary Outcome Measures :
  1. PaO2(partial pressure of arterial oxygen) [ Time Frame: 30 min after treatment ]
    ABGA

  2. Pulmonary shunt fraction [ Time Frame: 30 min after treatment ]
    Qs/Qt = (CcO2-CaO2) / (CcO2-CvO2)


Eligibility Criteria
Layout table for eligibility information
Ages Eligible for Study:   20 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • 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
Contacts and Locations

Locations
Layout table for location information
Korea, Republic of
Seoul St.Mary's Hospital
Seoul, Korea, Republic of
Sponsors and Collaborators
Seoul St. Mary's Hospital
The Catholic University of Korea
Investigators
Layout table for investigator information
Principal Investigator: Wonjung Hwang Seoul St. Mary's Hospital
Tracking Information
First Submitted Date  ICMJE April 8, 2019
First Posted Date  ICMJE May 3, 2019
Last Update Posted Date May 3, 2019
Actual Study Start Date  ICMJE January 4, 2018
Actual Primary Completion Date October 24, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 1, 2019)
  • PaO2(partial pressure of arterial oxygen) [ Time Frame: 30 min after treatment ]
    ABGA
  • Pulmonary shunt fraction [ Time Frame: 30 min after treatment ]
    Qs/Qt = (CcO2-CaO2) / (CcO2-CvO2)
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE The Effect of Iloprost on Oxygenation During One-lung Ventilation for Lung Surgery
Official Title  ICMJE The Effect of Iloprost on Arterial Oxygenation and Shunt Fraction During One-lung Ventilation for Lung Surgery
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Lung Cancer
Intervention  ICMJE
  • Drug: Inhaled iloprost
    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
    Study drug was inhaled to ventilated lung through a nebulized system in inspiratory limb after one-lung ventilation in the lateral decubitus position.
Study Arms  ICMJE
  • Experimental: Iloprost 10

    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.

    Intervention: Drug: Inhaled iloprost
  • Experimental: Iloprost 20

    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.

    Intervention: Drug: Inhaled iloprost
  • Placebo Comparator: Distilled water

    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.

    Intervention: Drug: Distilled water
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: May 1, 2019) 		72
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE October 24, 2018
Actual Primary Completion Date October 24, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

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

Exclusion Criteria:

  • 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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 20 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Korea, Republic of
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03936140
Other Study ID Numbers  ICMJE KC14MISI0880
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party Wonjung Hwang, Seoul St. Mary's Hospital
Study Sponsor  ICMJE Seoul St. Mary's Hospital
Collaborators  ICMJE The Catholic University of Korea
Investigators  ICMJE
Principal Investigator: Wonjung Hwang Seoul St. Mary's Hospital
PRS Account Seoul St. Mary's Hospital
Verification Date May 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

治疗医院

新药特效药

前沿医讯