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The Effects of Secondary Smoking During One Lung Ventilation

Primary Purpose

Smoking, Oxygen Deficiencies

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
One Lung Ventilation
Sponsored by
Inonu University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Smoking focused on measuring secondary smoking, one lung ventilation, arterial oxygen tension, lobectomy

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)Does not accept healthy volunteers

Inclusion Criteria:

  • Sixty patients undergoing lobectomy using one lung ventilation by double lumen tube, ASA physical status 2 and 3.

Exclusion Criteria:

  • Recent chest infection, morbid obesity, renal, hepatic and ischemic hearts disease, asthma.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Active Comparator

    Arm Label

    Group S (non smoking and secondary smoking)

    Group SS (secondary smoking)

    Arm Description

    I want to see the effects of seconder smoking to intraoperative arterial oxygen tension during one lung ventilation for lobectomy surgery.

    I want to see the effects of seconder smoking to intraoperative arterial oxygen tension during one lung ventilation for lobectomy surgery.

    Outcomes

    Primary Outcome Measures

    arterial oxygen tension
    arterial carbon dioxide tension
    intraoperative peak airway pressure

    Secondary Outcome Measures

    Full Information

    First Posted
    December 22, 2016
    Last Updated
    April 4, 2017
    Sponsor
    Inonu University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03006224
    Brief Title
    The Effects of Secondary Smoking During One Lung Ventilation
    Official Title
    The Effects of Secondary Smoking to Intraoperative Arterial Oxygen Tension During One Lung Ventilation in Lobectomy
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    April 2017
    Overall Recruitment Status
    Completed
    Study Start Date
    December 2016 (Actual)
    Primary Completion Date
    February 2017 (Actual)
    Study Completion Date
    April 4, 2017 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Inonu University

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    Smoking and perhaps secondary smoking is associated with many perioperative and postoperative complications, especially respiratory events. Hypoxemia and airway damage can be associated with secondary smoking. The aim of study is to predict the incidence of hypoxemia and airway damage during one lung ventilation for lobectomy.
    Detailed Description
    Sixty patients undergoing lobectomy using one lung ventilation by double lumen tube will be included in this study. These patients will be divided into 2 groups. Groups S which will be included non smoking and secondary smoking and group SS which will be included secondary smoking ( smoking near him more than 10 cigarettes per day fore more than 5 years). Intra and postoperative arterial oxygen tension, arterial carbon dioxide tension and intraoperative peak airway pressure will be compared between the two groups.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Smoking, Oxygen Deficiencies
    Keywords
    secondary smoking, one lung ventilation, arterial oxygen tension, lobectomy

    7. Study Design

    Primary Purpose
    Other
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    Investigator
    Allocation
    Randomized
    Enrollment
    60 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Group S (non smoking and secondary smoking)
    Arm Type
    Active Comparator
    Arm Description
    I want to see the effects of seconder smoking to intraoperative arterial oxygen tension during one lung ventilation for lobectomy surgery.
    Arm Title
    Group SS (secondary smoking)
    Arm Type
    Active Comparator
    Arm Description
    I want to see the effects of seconder smoking to intraoperative arterial oxygen tension during one lung ventilation for lobectomy surgery.
    Intervention Type
    Other
    Intervention Name(s)
    One Lung Ventilation
    Primary Outcome Measure Information:
    Title
    arterial oxygen tension
    Time Frame
    From beginning of Anesthesia to 1st day of surgery
    Title
    arterial carbon dioxide tension
    Time Frame
    From beginning of Anesthesia to 1st day of surgery
    Title
    intraoperative peak airway pressure
    Time Frame
    during intraoperative ventilation

    10. Eligibility

    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Sixty patients undergoing lobectomy using one lung ventilation by double lumen tube, ASA physical status 2 and 3. Exclusion Criteria: Recent chest infection, morbid obesity, renal, hepatic and ischemic hearts disease, asthma.

    12. IPD Sharing Statement

    Plan to Share IPD
    Undecided

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    The Effects of Secondary Smoking During One Lung Ventilation

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