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

Primary Purpose

One-lung Ventilation, Chronic Obstructive Pulmonary Disease

Status
Recruiting
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
5ml of inhaled normal saline
2.5mg (2.5ml) of inhaled salbutamol and 2.5ml of inhaled normal saline
Sponsored by
Yonsei University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for One-lung Ventilation

Eligibility Criteria

40 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Severance Hospital, Yonsei University Health SystemRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Experimental

Arm Label

Control group

Salbutamol group

Arm Description

Normal saline

Salbutamol + normal saline

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
June 13, 2023
Last Updated
June 13, 2023
Sponsor
Yonsei University
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1. Study Identification

Unique Protocol Identification Number
NCT05914285
Brief Title
Assessment of Salbutamol Effect on Arterial Oxygenation in COPD Patients During One-lung Ventilation
Official Title
Assessment of Salbutamol Effect on Arterial Oxygenation in COPD Patients During One-lung Ventilation
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Recruiting
Study Start Date
April 25, 2023 (Actual)
Primary Completion Date
April 21, 2025 (Anticipated)
Study Completion Date
April 21, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Yonsei University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
One-lung Ventilation, Chronic Obstructive Pulmonary Disease

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
90 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Control group
Arm Type
Placebo Comparator
Arm Description
Normal saline
Arm Title
Salbutamol group
Arm Type
Experimental
Arm Description
Salbutamol + normal saline
Intervention Type
Drug
Intervention Name(s)
5ml of inhaled normal saline
Intervention Description
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
Intervention Name(s)
2.5mg (2.5ml) of inhaled salbutamol and 2.5ml of inhaled normal saline
Intervention Description
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.
Primary Outcome Measure Information:
Title
PaO2 (partial pressure of arterial oxygen) to FiO2 (fraction of inspired oxygen) ratio (P/F ratio)
Description
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.
Time Frame
Thirty minutes after the completion of drug inhalation

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Young Jun Oh
Phone
82-2-2224-1636
Email
yjoh@yuhs.ac
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Young Jun Oh
Organizational Affiliation
Department of Anesthesiology and Pain Medicine, Severance Hospital, Yonsei University Health System, Seoul, Korea
Official's Role
Principal Investigator
Facility Information:
Facility Name
Severance Hospital, Yonsei University Health System
City
Seoul
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Young Jun Oh
Phone
82-2-2224-1636
Email
yjoh@yuhs.ac

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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