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

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Yonsei University

Status

Active, not recruiting

Conditions

One-lung Ventilation
Chronic Obstructive Pulmonary Disease

Treatments

Drug: 5ml of inhaled normal saline
Drug: 2.5mg (2.5ml) of inhaled salbutamol and 2.5ml of inhaled normal saline

Study type

Interventional

Funder types

Other

Identifiers

NCT05914285
4-2023-0242

Details and patient eligibility

About

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.

Enrollment

90 patients

Sex

All

Ages

40 to 80 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

90 participants in 2 patient groups, including a placebo group

Control group
Placebo Comparator group
Description:
Normal saline
Treatment:
Drug: 5ml of inhaled normal saline
Salbutamol group
Experimental group
Description:
Salbutamol + normal saline
Treatment:
Drug: 2.5mg (2.5ml) of inhaled salbutamol and 2.5ml of inhaled normal saline

Trial contacts and locations

1

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Central trial contact

Young Jun Oh

Data sourced from clinicaltrials.gov

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