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Clinical Trials/NCT05914285
NCT05914285
Active, not recruiting
Not Applicable

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

Yonsei University1 site in 1 country90 target enrollmentApril 25, 2023

Overview

Phase
Not Applicable
Intervention
5ml of inhaled normal saline
Conditions
One-lung Ventilation
Sponsor
Yonsei University
Enrollment
90
Locations
1
Primary Endpoint
PaO2 (partial pressure of arterial oxygen) to FiO2 (fraction of inspired oxygen) ratio (P/F ratio)
Status
Active, not recruiting
Last Updated
10 months ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
April 25, 2023
End Date
July 21, 2025
Last Updated
10 months ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

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

Arms & Interventions

Control group

Normal saline

Intervention: 5ml of inhaled normal saline

Salbutamol group

Salbutamol + normal saline

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

Outcomes

Primary Outcomes

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.

Study Sites (1)

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