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NCT Number: NCT04583046

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

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.

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Key information

Conditions

Lung Cancer (Including Metastatic Cancer) Lung Diseases Lung Neoplasms Neoplasms Neoplasms by Site Pulmonary Infection Respiratory Tract Diseases Respiratory Tract Neoplasms Thoracic Neoplasms

Age range

40 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Severance Hospital

Seoul, South Korea

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)
  • arrhythmia
  • pregnant women
  • pulmonary edema or pulmonary arterial hypertension
  • cerebrovascular disease
  • unstable angina or myocardial infarction within 6 months
  • patients with allergic reaction at iloprost

Treatment and study plan

normal saline inhalation

Drug

When anesthesia induction finishes, change patients' position from supine to lateral position and measure ABGA, VBGA while two lung is ventilated (T0). After 20 minutes of applying one-lung ventilation, measure ABGA and VBGA (T1). Apply normal saline inhalation for control group and measure ABGA at the time of 20 min after normal saline inhalation has finished (T2).

iloprost inhalation

Drug

When anesthesia induction finishes, change patients' position from supine to lateral position and measure ABGA, VBGA while two lung is ventilated (T0). After 20 minutes of applying one-lung ventilation, measure ABGA and VBGA (T1). Apply iloprost inhalation for iloprost group and measure ABGA at the time of 20 min after iloprost inhalation has finished (T2).

Primary outcomes

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

    Time frame: 20 minutes after iloprost inhalation (T2)

  2. 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)

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

    Time frame: 20 minutes after iloprost inhalation (T2)

Secondary outcomes

  1. deadspace

    Time frame: 20 minutes after iloprost inhalation (T2)

    Dead space ventilation was calculated with Paco2 and end-tidal carbon dioxide (Etco2) according to the Hardman and Aitkenhead equation [1.14 × (Paco2- Etco2)/Paco2 - 0.005].

  2. intrapulmonary shunt

    Time frame: 20 minutes after iloprost inhalation (T2)

    -Shunt fraction (Qs/Qt) was calculated using the following formula: Qs/Qt = (CcO2-CaO2)/(CcO2-CvO2), (1)

    -whereby:

    • CaO2 = (PaO2 x 0.0031) + (Hemoglobin x 1.36 x SaO2), (2)
    • CvO2 = (PvO2 x 0.0031) + (Hemoglobin x 1.36 x SvO2), (3)
    • CcO2 = ([FiO2 x (PB - PH2O) - PaCO2/Respiratory quotient] x 0.0031) + (Hemoglobin x 1.36), (4)
    • PB is the barometric pressure (760 mmHg), the PH2O is 47 mmHg

Sponsors and collaborators

Lead sponsor

Yonsei University

Other

Registry information

Important dates

Study start
2020
Primary completion
2025
Study completion
2025
First posted
Oct 12, 2020
Registry last updated
Dec 1, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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