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

NCT05914285 | Active Not Recruiting

• 1 other identifier: 4-2023-0242
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

One-lung Ventilation; Chronic Obstructive Pulmonary Disease

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Control group

PLACEBO COMPARATOR

Normal saline

Drug: 5ml of inhaled normal saline

Salbutamol group

EXPERIMENTAL

Salbutamol + normal saline

Drug: 2.5mg (2.5ml) of inhaled salbutamol and 2.5ml of inhaled normal saline

Interventions

5ml of inhaled normal saline DRUG

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.

Control group

2.5mg (2.5ml) of inhaled salbutamol and 2.5ml of inhaled normal saline DRUG

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.

Salbutamol group

Eligibility Criteria

• Age: 40 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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%)

You may not qualify if:

• 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

Sponsors & Collaborators

• Yonsei University: lead

Study Sites (1)

Severance Hospital, Yonsei University Health System

Seoul, South Korea

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Young Jun Oh

  Department of Anesthesiology and Pain Medicine, Severance Hospital, Yonsei University Health System, Seoul, Korea

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 13, 2023
• First Posted: June 22, 2023
• Study Start: April 25, 2023
• Primary Completion: June 20, 2025
• Study Completion: July 21, 2025
• Last Updated: July 1, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)