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

Pulmonary Infection Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04583046
• Other study ID #: 4-2020-0722
• Status: Not yet recruiting
• Phase: N/A
• Start date: October 2020
• Est. completion date: August 2022

Study information

• Verified date: October 2020
• Source: Yonsei University
• Contact: Young Jun Oh
• Phone: +82-2-2228-2423
• Email: yjoh[@]yuhs.ac
• 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, the investigator is planning to investigate the effects of iloprost on respiratory physiology (intrapulmonary shunt, deadspace, oxygenation, etc) in obese patients.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 78
• Est. completion date: August 2022
• Est. primary completion date: August 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Lung Cancer (Including Metastatic Cancer)
• Neoplasm Metastasis
• Pulmonary Infection

Intervention

Drug:
• normal saline inhalation
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
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).

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Yonsei University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Result of arterial blood gas analysis : partial pressure of oxygen(PaO2)		20 minutes after iloprost inhalation (T2)
Primary	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)
Primary	Result of arterial blood gas analysis : Oxygen saturation in arterial blood(SaO2)		20 minutes after iloprost inhalation (T2)
Secondary	deadspace	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].	20 minutes after iloprost inhalation (T2)
Secondary	intrapulmonary shunt	-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	20 minutes after iloprost inhalation (T2)