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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

90 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-04-25

Study Completion Date

2025-07-21

Brief Summary

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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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Detailed Description

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Conditions

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One-lung Ventilation Chronic Obstructive Pulmonary Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Control group

Normal saline

Group Type PLACEBO_COMPARATOR

5ml of inhaled normal saline

Intervention Type 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.

Salbutamol group

Salbutamol + normal saline

Group Type EXPERIMENTAL

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

Intervention Type 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.

Interventions

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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.

Intervention Type 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.

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

40 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No