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

NCT ID: NCT03936140

Last Updated: 2019-05-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 72 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-01-04
• Study Completion Date: 2018-10-24

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.

Conditions

Lung Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

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.

Group Type: EXPERIMENTAL

Inhaled iloprost

Intervention Type: DRUG

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

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.

Group Type: EXPERIMENTAL

Inhaled iloprost

Intervention Type: DRUG

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

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.

Group Type: PLACEBO_COMPARATOR

Distilled water

Intervention Type: DRUG

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

Interventions

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.

Intervention Type: 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.

Intervention Type: DRUG

Eligibility 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

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

The Catholic University of Korea

OTHER

Sponsor Role: collaborator

Seoul St. Mary's Hospital

OTHER

Sponsor Role: lead

Responsible Party

Wonjung Hwang

Assistant professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Wonjung Hwang

Role: PRINCIPAL_INVESTIGATOR

Seoul St. Mary's Hospital

Locations

Seoul St.Mary's Hospital

Seoul, , South Korea

Countries

South Korea

Other Identifiers

KC14MISI0880

Identifier Type: -

Identifier Source: org_study_id