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

Gastroesophageal Reflux Clinical Trial

— LMA  

Official title:

Incidence of Gastroesophageal Reflux During LMA Application in Control and Spontaneous Ventilation

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02441257
• Other study ID #: EHBH
• Status: Not yet recruiting
• Phase: N/A
• First received: January 25, 2015
• Last updated: May 11, 2015
• Start date: August 2015
• Est. completion date: October 2016

Study information

• Verified date: May 2015
• Source: Eastern Hepatobiliary Surgery Hospital
• Contact: Zhenmeng Wang, Doctor
• Phone: +8613601919501
• Email: wzm11998[@]163.com
• Is FDA regulated: No
• Health authority: China: Science and Technology Commission of Shanghai Municipality
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 200
• Est. completion date: October 2016
• Est. primary completion date: July 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Gastroesophageal Reflux

Intervention

Procedure:
• control ventilation
patients are randomly divided to receive control or spontaneous ventilation randomly.
• spontaneous ventilation
patients are randomly divided to receive control or spontaneous ventilation randomly.

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Zhenmeng Wang	Wake Forest Baptist Health

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes