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

Lung Cancer Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02784899
• Other study ID #: 4-2015-0706
• Status: Completed
• Phase: N/A
• Start date: October 8, 2015
• Est. completion date: June 30, 2017

Study information

• Verified date: June 2018
• Source: Yonsei University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: June 30, 2017
• Est. primary completion date: June 30, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 80 Years

Eligibility

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)

Related Conditions & MeSH terms

• Lung Cancer

Intervention

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.
• 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.

Locations

Country	Name	City	State
Korea, Republic of	Department of Anaesthesiology and Pain Medicine, Anaesthesia and Pain Research Institute, Yonsei University College of Medicine	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Yonsei University

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	PaO2(partial pressure of arterial oxygen) ratio		40 minutes after iloprost inhalation
Primary	incidence of intrapulmonary shunt		40 minutes after iloprost inhalation