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

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.

Study Overview

• Status: Recruiting
• Conditions: Chronic Obstructive Pulmonary Disease; One-lung Ventilation
• Intervention / Treatment: Drug: 5ml of inhaled normal saline; Drug: 2.5mg (2.5ml) of inhaled salbutamol and 2.5ml of inhaled normal saline

• Study Type: Interventional
• Enrollment (Estimated): 90
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Young Jun Oh; Phone Number: 82-2-2224-1636; Email: yjoh@yuhs.ac

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of
    • Recruiting
    • Severance Hospital, Yonsei University Health System
    • Contact: Young Jun Oh; Phone Number: 82-2-2224-1636; Email: yjoh@yuhs.ac

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Patient age 40~80yrs, scheduled for videoscope-assisted pulmonary lobectomy
• American Society of Anesthesiologists Class III 또는 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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Control group; Normal saline	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.
Experimental: Salbutamol group; Salbutamol + normal saline	Drug: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Yonsei University
• Investigators: Principal Investigator: Young Jun Oh, Department of Anesthesiology and Pain Medicine, Severance Hospital, Yonsei University Health System, Seoul, Korea

Study record dates

Study Major Dates

• Study Start (Actual): April 25, 2023
• Primary Completion (Estimated): April 21, 2025
• Study Completion (Estimated): April 21, 2025

Study Registration Dates

• First Submitted: June 13, 2023
• First Submitted That Met QC Criteria: June 13, 2023
• First Posted (Actual): June 22, 2023

Study Record Updates

• Last Update Posted (Actual): June 22, 2023
• Last Update Submitted That Met QC Criteria: June 13, 2023
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Respiratory Tract Diseases; Lung Diseases; Disease Attributes; Chronic Disease; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive; Physiological Effects of Drugs; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Autonomic Agents; Peripheral Nervous System Agents; Adrenergic Agonists; Bronchodilator Agents; Anti-Asthmatic Agents; Respiratory System Agents; Reproductive Control Agents; Adrenergic beta-2 Receptor Agonists; Adrenergic beta-Agonists; Tocolytic Agents; Albuterol
• Other Study ID Numbers: 4-2023-0242

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No