Assessment of Salbutamol Effect on Arterial Oxygenation in COPD Patients During One-lung Ventilation

Chronic Obstructive Pulmonary Disease Clinical Trial

Official title:

Assessment of Salbutamol Effect on Arterial Oxygenation in COPD Patients During One-lung Ventilation

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05914285
• Other study ID #: 4-2023-0242
• Status: Recruiting
• Phase: N/A
• 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
• 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

Related Conditions & MeSH terms

• Chronic Obstructive Pulmonary Disease
• Lung Diseases, Obstructive
• One-lung Ventilation
• Pulmonary Disease, Chronic Obstructive

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