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Clinical Trials/NCT04583046
NCT04583046
Completed
Not Applicable

Effects of Iloprost on Pulmonary Oxygenation in Obese Patients During One-lung Ventilation

Yonsei University1 site in 1 country78 target enrollmentNovember 2, 2020

Overview

Phase
Not Applicable
Intervention
normal saline inhalation
Conditions
Lung Cancer (Including Metastatic Cancer)
Sponsor
Yonsei University
Enrollment
78
Locations
1
Primary Endpoint
Result of arterial blood gas analysis : partial pressure of oxygen(PaO2)
Status
Completed
Last Updated
5 months ago

Overview

Brief 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, the investigator is planning to investigate the effects of iloprost on respiratory physiology (intrapulmonary shunt, deadspace, oxygenation, etc) in obese patients.

Registry
clinicaltrials.gov
Start Date
November 2, 2020
End Date
September 26, 2025
Last Updated
5 months ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • scheduled for VATS lobectomy
  • 40 \< age \< 80
  • American Society of Anaesthesiologists(ASA) physical status classification I\~III
  • BMI \> 30 kg /m2

Exclusion Criteria

  • American Society of Anaesthesiologists(ASA) physical status classification IV or more
  • 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)
  • pregnant women
  • pulmonary edema or pulmonary arterial hypertension
  • cerebrovascular disease
  • unstable angina or myocardial infarction within 6 months
  • patients with allergic reaction at iloprost

Arms & Interventions

placebo

normal saline inhalation group

Intervention: normal saline inhalation

iloprost group

iloprost inhalation group

Intervention: iloprost inhalation

Outcomes

Primary Outcomes

Result of arterial blood gas analysis : partial pressure of oxygen(PaO2)

Time Frame: 20 minutes after iloprost inhalation (T2)

Result of arterial blood gas analysis : partial pressure of oxygen in the arterial blood(PaO2)/Fraction of inspired oxygen(FiO2) ratio (P/F ratio)

Time Frame: 20 minutes after iloprost inhalation (T2)

Result of arterial blood gas analysis : Oxygen saturation in arterial blood(SaO2)

Time Frame: 20 minutes after iloprost inhalation (T2)

Secondary Outcomes

  • deadspace(20 minutes after iloprost inhalation (T2))
  • intrapulmonary shunt(20 minutes after iloprost inhalation (T2))

Study Sites (1)

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