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
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
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
NCT ID
NCT02441257
First Posted
January 25, 2015
Last Updated
May 11, 2015
Sponsor
Zhenmeng Wang
Collaborators
Wake Forest University Health Sciences
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)
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