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Effect of Preoperative Budesonide Inhalation on Arterial Blood Oxygenation and Intrapulmonary Shunt During OLV

Primary Purpose

Lung Cancer

Status
Completed
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
preoperative budesonide inhalation
preoperative normal saline inhalation
Sponsored by
Fujian Medical University Union Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Lung Cancer

Eligibility Criteria

45 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Aged 45 yr to 65 yr ,height 155-176cm,weight 45-75kg,body mass index(BMI)18-27kg/m2,ASA Physical Status Classifications I to II,left-lateral position during OLV ,normal cardiac and pulmonary function ,and no cardiac,hepatic,renal and endocrine diseases.Diagnosed with uncomplicated lung cancer and was to receive video-assist thoracoscopic lobectomy under general anesthesia.

Exclusion Criteria:

  • FEV1/FVC<70%,asthma,chronic obstructive pulmonary disease,acute lung infection,past history of thoracic surgery. preoperative glucocorticoid medication,preoperative chemotherapy,SpO2 kept below 90% for more than 15 minutes during operation,blood transfusion during operation,OLV less than an hour,occurrence of severe complications like allergic shock.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Placebo Comparator

    Arm Label

    Budesonide inhalation group

    Normal saline inhalation group

    Arm Description

    This group of participants were to receive 2mg/4ml of preoperative budesonide inhalation (Khartoum Road NORTH RYDE NSW 2113 Australia. AstraZeneca Pty Ltd) for 10 to 15min.

    This group of participants were to receive4ml of preoperative normal saline inhalation for 10 to 15min.

    Outcomes

    Primary Outcome Measures

    Arterial blood oxygenation
    Arterial blood oxygenation was assessed through blood gas analysis of sample taken from radial artery

    Secondary Outcome Measures

    Intrapulmonary shunt
    Intrapulmonary shunt was assessed through blood gas analysis of sample taken

    Full Information

    First Posted
    January 3, 2018
    Last Updated
    January 3, 2018
    Sponsor
    Fujian Medical University Union Hospital
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03394222
    Brief Title
    Effect of Preoperative Budesonide Inhalation on Arterial Blood Oxygenation and Intrapulmonary Shunt During OLV
    Official Title
    Effect of Preoperative Budesonide Inhalation on Arterial Blood Oxygenation and Intrapulmonary Shunt in Patients Received One-lung Ventilation
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    January 2018
    Overall Recruitment Status
    Completed
    Study Start Date
    July 2016 (Actual)
    Primary Completion Date
    March 2017 (Actual)
    Study Completion Date
    April 2017 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Fujian Medical University Union Hospital

    4. Oversight

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

    5. Study Description

    Brief Summary
    The purpose of this study is to conduct a randomized controlled trial to evaluate the effect of preoperative budesonide inhalation on arterial blood oxygenation and intrapulmonary shunt in patients received one-lung ventilation
    Detailed Description
    Population: The target population comprises all adult aged 45-65 years who was diagnosed lung cancer and to receive video-assist thoracoscopic lobectomy under general anethesia.The study sample will include 50 subjects of both gender and any race or ethnicity. Procedures: Eligible and consented patients will be enrolled into the study if all eligibility criteria are met and will be randomly allocated to one of the two study arms:Budesonide inhalation group vs Normal saline inhalation group Study Duration: Overall duration of the study is 10 months.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Lung Cancer

    7. Study Design

    Primary Purpose
    Supportive Care
    Study Phase
    Phase 4
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantCare Provider
    Masking Description
    One research assistant was tasked to give the interventional medication in indentical containers to the anesthesiologists(care provider) in charge of the participants for preoperative preparations.Both the participants and care providers were blinded.
    Allocation
    Randomized
    Enrollment
    50 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Budesonide inhalation group
    Arm Type
    Experimental
    Arm Description
    This group of participants were to receive 2mg/4ml of preoperative budesonide inhalation (Khartoum Road NORTH RYDE NSW 2113 Australia. AstraZeneca Pty Ltd) for 10 to 15min.
    Arm Title
    Normal saline inhalation group
    Arm Type
    Placebo Comparator
    Arm Description
    This group of participants were to receive4ml of preoperative normal saline inhalation for 10 to 15min.
    Intervention Type
    Drug
    Intervention Name(s)
    preoperative budesonide inhalation
    Intervention Type
    Drug
    Intervention Name(s)
    preoperative normal saline inhalation
    Primary Outcome Measure Information:
    Title
    Arterial blood oxygenation
    Description
    Arterial blood oxygenation was assessed through blood gas analysis of sample taken from radial artery
    Time Frame
    Arterial blood oxygenation was assessed through blood gas analysis before intervention,before OLV ,10 min after OLV,30 min after OLV,60 min after OLV and 10min after two-lung ventilation.
    Secondary Outcome Measure Information:
    Title
    Intrapulmonary shunt
    Description
    Intrapulmonary shunt was assessed through blood gas analysis of sample taken
    Time Frame
    Intrapulmonary shunt was assessed through blood gas analysis before intervention,before OLV ,10 min after OLV,30 min after OLV,60 min after OLV and 10min after two-lung ventilation

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    45 Years
    Maximum Age & Unit of Time
    65 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Aged 45 yr to 65 yr ,height 155-176cm,weight 45-75kg,body mass index(BMI)18-27kg/m2,ASA Physical Status Classifications I to II,left-lateral position during OLV ,normal cardiac and pulmonary function ,and no cardiac,hepatic,renal and endocrine diseases.Diagnosed with uncomplicated lung cancer and was to receive video-assist thoracoscopic lobectomy under general anesthesia. Exclusion Criteria: FEV1/FVC<70%,asthma,chronic obstructive pulmonary disease,acute lung infection,past history of thoracic surgery. preoperative glucocorticoid medication,preoperative chemotherapy,SpO2 kept below 90% for more than 15 minutes during operation,blood transfusion during operation,OLV less than an hour,occurrence of severe complications like allergic shock.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Wenhua chen, M.D.
    Organizational Affiliation
    Fujian Medical University Union Hospital
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

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    Effect of Preoperative Budesonide Inhalation on Arterial Blood Oxygenation and Intrapulmonary Shunt During OLV

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