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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03936140
Other study ID # KC14MISI0880
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date January 4, 2018
Est. completion date October 24, 2018

Study information

Verified date May 2019
Source Seoul St. Mary's Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 72
Est. completion date October 24, 2018
Est. primary completion date October 24, 2018
Accepts healthy volunteers No
Gender All
Age group 20 Years to 75 Years
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

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.
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.

Locations

Country Name City State
Korea, Republic of Seoul St.Mary's Hospital Seoul

Sponsors (2)

Lead Sponsor Collaborator
Seoul St. Mary's Hospital The Catholic University of Korea

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type Measure Description Time frame Safety issue
Primary PaO2(partial pressure of arterial oxygen) ABGA 30 min after treatment
Primary Pulmonary shunt fraction Qs/Qt = (CcO2-CaO2) / (CcO2-CvO2) 30 min after treatment
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