search
Back to results

Gastroesophageal Reflux During LMA in Control Ventilation (LMA, Laryngeal Mask Airway) (LMA)

Primary Purpose

Gastroesophageal Reflux

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
control ventilation
spontaneous ventilation
Sponsored by
Zhenmeng Wang
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Gastroesophageal Reflux focused on measuring Gastroesophageal Reflux, Laryngeal Mask Airway, Control Ventilation, Spontaneous Ventilation

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • patients for lower extremity operations;
  • patients for urological operations;
  • patients for gynecological operations.

Exclusion Criteria:

  • gastroesophageal reflux disease;
  • body mass index more than 30.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    control ventilation

    Arm Description

    patients are scheduled to receive control or spontaneous ventilation

    Outcomes

    Primary Outcome Measures

    incidence of gastroesophageal reflux of participants
    evaluate the exact incidence of reflux in LMA patients with catheter-based Digitrapper ph-Z monitor system

    Secondary Outcome Measures

    Full Information

    First Posted
    January 25, 2015
    Last Updated
    May 11, 2015
    Sponsor
    Zhenmeng Wang
    Collaborators
    Wake Forest University Health Sciences
    search

    1. Study Identification

    Unique Protocol Identification Number
    NCT02441257
    Brief Title
    Gastroesophageal Reflux During LMA in Control Ventilation (LMA, Laryngeal Mask Airway)
    Acronym
    LMA
    Official Title
    Incidence of Gastroesophageal Reflux During LMA Application in Control and Spontaneous Ventilation
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    May 2015
    Overall Recruitment Status
    Unknown status
    Study Start Date
    August 2015 (undefined)
    Primary Completion Date
    July 2016 (Anticipated)
    Study Completion Date
    October 2016 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor-Investigator
    Name of the Sponsor
    Zhenmeng Wang
    Collaborators
    Wake Forest University Health Sciences

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    Laryngeal mask airway is seldom used for control ventilation in America, while it is popular in China. The question is whether the incidence of gastroesophageal reflux in control ventilation is really higher than in spontaneous ventilation. So the investigators combine the third generation laryngeal mask and catheter-based Digitrapper ph-Z monitor system to evaluate the exact incidence of gastroesophageal reflux in these two groups.
    Detailed Description
    Patients scheduled for LMA ventilation are divided into two groups randomly, control ventilation group and spontaneous ventilation group. After the third generation laryngeal mask is inserted, catheter-based Digitrapper ph-Z monitor system is applied to measure the exact incidence of gastroesophageal reflux in these two groups.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Gastroesophageal Reflux
    Keywords
    Gastroesophageal Reflux, Laryngeal Mask Airway, Control Ventilation, Spontaneous Ventilation

    7. Study Design

    Primary Purpose
    Diagnostic
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Masking
    ParticipantCare ProviderInvestigatorOutcomes Assessor
    Allocation
    N/A
    Enrollment
    200 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    control ventilation
    Arm Type
    Experimental
    Arm Description
    patients are scheduled to receive control or spontaneous ventilation
    Intervention Type
    Procedure
    Intervention Name(s)
    control ventilation
    Intervention Description
    patients are randomly divided to receive control or spontaneous ventilation randomly.
    Intervention Type
    Procedure
    Intervention Name(s)
    spontaneous ventilation
    Intervention Description
    patients are randomly divided to receive control or spontaneous ventilation randomly.
    Primary Outcome Measure Information:
    Title
    incidence of gastroesophageal reflux of participants
    Description
    evaluate the exact incidence of reflux in LMA patients with catheter-based Digitrapper ph-Z monitor system
    Time Frame
    participants will be monitored for the duration of laryngeal mask application, an expected average of 1.5 hours

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: patients for lower extremity operations; patients for urological operations; patients for gynecological operations. Exclusion Criteria: gastroesophageal reflux disease; body mass index more than 30.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Zhenmeng Wang, Doctor
    Phone
    +8613601919501
    Email
    wzm11998@163.com
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Zhenmeng Wang, Doctor
    Organizational Affiliation
    Eastern Hepatobiliary Surgery Hospital
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Learn more about this trial

    Gastroesophageal Reflux During LMA in Control Ventilation (LMA, Laryngeal Mask Airway)

    We'll reach out to this number within 24 hrs