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

Not Applicable

Recruiting

• Conditions: Chronic Obstructive Pulmonary Disease; One-lung Ventilation
• Interventions: Drug: 5ml of inhaled normal saline; Drug: 2.5mg (2.5ml) of inhaled salbutamol and 2.5ml of inhaled normal saline

• Registration Number: NCT05914285
• Lead Sponsor: Yonsei University

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-04-25
• Status Verified: 2023-06
• Study First Submitted: 2023-06-13
• Study First Submitted QC: 2023-06-13
• Last Update Submitted: 2023-06-13
• Study First Posted: 2023-06-22
• Last Update Posted: 2023-06-22
• Primary Completion: 2025-04-21
• Study Completion: 2025-04-21

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 90

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control group	5ml of inhaled normal saline	Normal saline
Salbutamol group	2.5mg (2.5ml) of inhaled salbutamol and 2.5ml of inhaled normal saline	Salbutamol + normal saline

Primary Outcome Measures

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

Trial Locations

Locations (1)

Severance Hospital, Yonsei University Health System; 🇰🇷 Seoul, Korea, Republic of