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NCT Number: NCT05914285

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.

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This study is active but is not currently recruiting participants.

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Key information

Conditions

One-Lung Ventilation Chronic Disease Chronic Obstructive Pulmonary Disease Disease Attributes Lung Diseases Lung Diseases, Obstructive Pathologic Processes Pathological Conditions, Signs and Symptoms Pulmonary Disease, Chronic Obstructive Respiratory Tract Diseases

Age range

40 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Severance Hospital, Yonsei University Health System

Seoul, South Korea

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

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.

Primary outcomes

  1. PaO2 (partial pressure of arterial oxygen) to FiO2 (fraction of inspired oxygen) ratio (P/F ratio)

    Time frame: Thirty minutes after the completion of drug inhalation

    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.

Sponsors and collaborators

Lead sponsor

Yonsei University

Other

Registry information

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Jun 22, 2023
Registry last updated
Jul 1, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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