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

Primary Purpose

Lung Cancer (Including Metastatic Cancer), Pulmonary Infection

Status

Unknown status

Phase

Not Applicable

Locations

Study Type

Interventional

Intervention

normal saline inhalation

iloprost inhalation

About this trial

This is an interventional treatment trial for Lung Cancer (Including Metastatic Cancer)

Eligibility Criteria

40 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Experimental

Arm Label

placebo

iloprost group

Arm Description

normal saline inhalation group

iloprost inhalation group

Outcomes

Primary Outcome Measures

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

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

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

Secondary Outcome Measures

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].

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

Full Information

NCT ID

NCT04583046

First Posted

September 17, 2020

Last Updated

October 4, 2020

Sponsor

Yonsei University

1. Study Identification

Unique Protocol Identification Number

NCT04583046

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

October 2020

Overall Recruitment Status

Unknown status

Study Start Date

October 2020 (Anticipated)

Primary Completion Date

August 2022 (Anticipated)

Study Completion Date

August 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Yonsei University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Lung Cancer (Including Metastatic Cancer), Pulmonary Infection

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

78 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

placebo

Arm Type

Placebo Comparator

Arm Description

normal saline inhalation group

Arm Title

iloprost group

Arm Type

Experimental

Arm Description

iloprost inhalation group

Intervention Type

Drug

Intervention Name(s)

normal saline inhalation

Intervention Description

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).

Intervention Type

Drug

Intervention Name(s)

iloprost inhalation

Intervention Description

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 Outcome Measure Information:

Title

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

Time Frame

20 minutes after iloprost inhalation (T2)

Title

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)

Title

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

Time Frame

20 minutes after iloprost inhalation (T2)

Secondary Outcome Measure Information:

Title

deadspace

Description

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].

Time Frame

20 minutes after iloprost inhalation (T2)

Title

intrapulmonary shunt

Description

Time Frame

20 minutes after iloprost inhalation (T2)

10. Eligibility

Sex

All

Minimum Age & Unit of Time

40 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

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) 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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Young Jun Oh

Phone

+82-2-2228-2423

yjoh@yuhs.ac

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Young Jun Oh

Organizational Affiliation

Severance Hospital

Official's Role

Principal Investigator

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

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

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