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

Not Applicable

• Conditions: Pulmonary Infection; Lung Cancer (Including Metastatic Cancer)
• Interventions: Drug: normal saline inhalation; Drug: iloprost inhalation

• Registration Number: NCT04583046
• Lead Sponsor: Yonsei University

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-09-17
• Status Verified: 2020-10
• Study Start: 2020-10
• Study First Submitted QC: 2020-10-04
• Last Update Submitted: 2020-10-04
• Study First Posted: 2020-10-12
• Last Update Posted: 2020-10-12
• Primary Completion: 2022-08
• Study Completion: 2022-08

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 78

Inclusion Criteria

1. scheduled for VATS lobectomy
2. 40 < age < 80
3. American Society of Anaesthesiologists(ASA) physical status classification I~III
4. BMI > 30 kg /m2

Exclusion Criteria

1. American Society of Anaesthesiologists(ASA) physical status classification IV or more
2. NYHA class III~IV
3. Severe obstructive lung disease and/or restrictive lung disease patients
4. patients with end-organ diseases (i.e. heart failure, respiratory failure, hepatic failure, renal failure)
5. arrhythmia
6. pregnant women
7. pulmonary edema or pulmonary arterial hypertension
8. cerebrovascular disease
9. unstable angina or myocardial infarction within 6 months
10. patients with allergic reaction at iloprost

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
placebo	normal saline inhalation	normal saline inhalation group
iloprost group	iloprost inhalation	iloprost inhalation group

Primary Outcome Measures

Name	Time	Method
Result of arterial blood gas analysis : partial pressure of oxygen(PaO2)	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)	20 minutes after iloprost inhalation (T2)
Result of arterial blood gas analysis : Oxygen saturation in arterial blood(SaO2)	20 minutes after iloprost inhalation (T2)

Secondary Outcome Measures

Name	Time	Method
deadspace	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 \[1.14 × (Paco2- Etco2)/Paco2 - 0.005\].
intrapulmonary shunt	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