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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05914285
Other study ID # 4-2023-0242
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date April 25, 2023
Est. completion date April 21, 2025

Study information

Verified date June 2023
Source Yonsei University
Contact Young Jun Oh
Phone 82-2-2224-1636
Email yjoh@yuhs.ac
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

One-lung ventilation (OLV) is essential part of anesthesia during thoracic procedures. However, OLV induces a drastic increase of intrapulmonary shunt due to maintained pulmonary perfusion through the nonventilated lung, which may result in severe hypoxemia. Although the protective mechanisms of hypoxic pulmonary vasoconstriction favorably modulate pulmonary perfusion to the ventilated lung, the effect is attenuated in patients with history of chronic obstructive pulmonary disease (COPD), which alters compliance of the pulmonary artery. Salbutamol is a selective short-acting beta2-agonist and when inhaled during OLV, it acts selectively on the pulmonary vasculature reducing pulmonary vascular resistance of well-ventilated lung. We hypothesized that inhaled salbutamol would alleviate ventilation-perfusion mismatch during OLV of COPD patients, and aimed to assess the effects of salbutamol on oxygenation in these patients.


Recruitment information / eligibility

Status Recruiting
Enrollment 90
Est. completion date April 21, 2025
Est. primary completion date April 21, 2025
Accepts healthy volunteers No
Gender All
Age group 40 Years to 80 Years
Eligibility Inclusion Criteria: - Patient age 40~80yrs, scheduled for videoscope-assisted pulmonary lobectomy - American Society of Anesthesiologists Class III ?? IV - Moderate or more severe COPD according to GOLD criteria (FEV1/FVC<70%, FEV1<80%) Exclusion Criteria: - New York Heart Association class >II - AST level =100 IU/mL or ALT = level 50 IU/L - Creatinine clearance < 30mL/min - History of severe coronary artery occlusive disease, unstable angina, or recent myocardial infarction within 6 months - History of pulmonary hypertension or pulmonary edema - History of cerebrovascular accident within 3 months

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
5ml of inhaled normal saline
After the initiation of OLV, 5ml of normal saline is inhaled for 20 minutes using ultrasonic nebulizer, which is connected to the inspiratory limb of the ventilator system. Arterial blood gas analysis is performed 30 minutes after the completion of drug inhalation.
2.5mg (2.5ml) of inhaled salbutamol and 2.5ml of inhaled normal saline
After the initiation of OLV, mixture of salbutamol 2.5mg and normal saline 2.5ml is inhaled for 20 minutes using ultrasonic nebulizer, which is connected to the inspiratory limb of the ventilator system. Arterial blood gas analysis is performed 30 minutes after the completion of drug inhalation.

Locations

Country Name City State
Korea, Republic of Severance Hospital, Yonsei University Health System Seoul

Sponsors (1)

Lead Sponsor Collaborator
Yonsei University

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type Measure Description Time frame Safety issue
Primary PaO2 (partial pressure of arterial oxygen) to FiO2 (fraction of inspired oxygen) ratio (P/F ratio) The P/F ratio is a widely-used objective tool to identify hypoxemic respiratory failure when supplemental oxygen has been administered. It can be used to evaluate the effect of salbutamol on oxygenation during OLV. Thirty minutes after the completion of drug inhalation
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