Gastroesophageal Reflux During LMA in Control Ventilation... | NCT02441257

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

NCT02441257

Sponsor

Zhenmeng Wang

Status

Unknown status

Last Update Posted

May 12, 2015Estimated

Enrollment

200Estimated

Phase

Not Applicable

Conditions

Gastroesophageal Reflux

Interventions

control ventilation
spontaneous ventilation

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2015

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 2015

Primary Completion Date

Jul 2016Estimated

Completion Date

Oct 2016Estimated

First Submitted Date

Jan 25, 2015

First Submission Date that Met QC Criteria

May 11, 2015

First Posted Date

May 12, 2015Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 11, 2015

Last Update Posted Date

May 12, 2015Estimated

Name	Class
Wake Forest University Health Sciences	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

200Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
control ventilation	Experimental	patients are scheduled to receive control or spontaneous ventilation	Procedure: control ventilation Procedure: spontaneous ventilation

Interventions

Name	Type	Description	Arm Group Labels	Other Names
control ventilation	Procedure	patients are randomly divided to receive control or spontaneous ventilation randomly.	control ventilation

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
incidence of gastroesophageal reflux of participants	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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Zhenmeng Wang, Doctor	Contact	+8613601919501		wzm11998@163.com

Overall Officials

Name	Affiliation	Role
Zhenmeng Wang, Doctor	Eastern Hepatobiliary Surgery Hospital	Principal Investigator

Locations

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D005764	Gastroesophageal Reflux

Ancestor Terms

ID	Term
D015154	Esophageal Motility Disorders
D003680	Deglutition Disorders
D004935	Esophageal Diseases
D005767	Gastrointestinal Diseases

Browse Leaves

Not provided

Browse Branches

Not provided