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

Sponsor

Yonsei University (Other)

Overall Status

Recruiting

CT.gov ID

NCT05914285

Collaborator

(none)

Enrollment

Location

Arms

23.9

Anticipated Duration (Months)

3.8

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
One-lung Ventilation Chronic Obstructive Pulmonary Disease	Drug: 5ml of inhaled normal saline Drug: 2.5mg (2.5ml) of inhaled salbutamol and 2.5ml of inhaled normal saline	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

90 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Participant)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Apr 25, 2023

Anticipated Primary Completion Date :

Apr 21, 2025

Anticipated Study Completion Date :

Apr 21, 2025

Arms and Interventions

Arm	Intervention/Treatment
Placebo Comparator: Control group Normal saline	Drug: 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.
Experimental: Salbutamol group Salbutamol + normal saline	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.

Arm

Intervention/Treatment

Placebo Comparator: Control group

Normal saline

Drug: 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.

Experimental: Salbutamol group

Salbutamol + normal saline

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.

Outcome Measures

Primary Outcome Measures

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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

40 Years to 80 Years

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Severance Hospital, Yonsei University Health System	Seoul		Korea, Republic of

Sponsors and Collaborators

Yonsei University

Investigators

Principal Investigator: Young Jun Oh, Department of Anesthesiology and Pain Medicine, Severance Hospital, Yonsei University Health System, Seoul, Korea

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Yonsei University

ClinicalTrials.gov Identifier:

NCT05914285

Other Study ID Numbers:

4-2023-0242

First Posted:

Jun 22, 2023

Last Update Posted:

Jun 22, 2023

Last Verified:

Jun 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Lung Diseases, Obstructive

Pulmonary Disease, Chronic Obstructive

Albuterol

Study Results

No Results Posted as of Jun 22, 2023