- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02441257
Gastroesophageal Reflux During LMA in Control Ventilation (LMA, Laryngeal Mask Airway) (LMA)
May 11, 2015 updated by: Zhenmeng Wang
Incidence of Gastroesophageal Reflux During LMA Application in Control and Spontaneous Ventilation
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.
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Anticipated)
200
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Zhenmeng Wang, Doctor
- Phone Number: +8613601919501
- Email: wzm11998@163.com
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: control ventilation
patients are scheduled to receive control or spontaneous ventilation
|
patients are randomly divided to receive control or spontaneous ventilation randomly.
patients are randomly divided to receive control or spontaneous ventilation randomly.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
incidence of gastroesophageal reflux of participants
Time Frame: participants will be monitored for the duration of laryngeal mask application, an expected average of 1.5 hours
|
evaluate the exact incidence of reflux in LMA patients with catheter-based Digitrapper ph-Z monitor system
|
participants will be monitored for the duration of laryngeal mask application, an expected average of 1.5 hours
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Zhenmeng Wang, Doctor, Eastern Hepatobiliary Surgery Hospital
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
August 1, 2015
Primary Completion (Anticipated)
July 1, 2016
Study Completion (Anticipated)
October 1, 2016
Study Registration Dates
First Submitted
January 25, 2015
First Submitted That Met QC Criteria
May 11, 2015
First Posted (Estimate)
May 12, 2015
Study Record Updates
Last Update Posted (Estimate)
May 12, 2015
Last Update Submitted That Met QC Criteria
May 11, 2015
Last Verified
May 1, 2015
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- EHBH
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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