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

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

Status

UNKNOWN

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02441257

Acronym

LMA

Enrollment

200

Registered

2015-05-12

Start date

2015-08-31

Completion date

2016-10-31

Last updated

2015-05-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Gastroesophageal Reflux

Keywords

Gastroesophageal Reflux, Laryngeal Mask Airway, Control Ventilation, Spontaneous Ventilation

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.

Interventions

PROCEDUREcontrol ventilation

patients are randomly divided to receive control or spontaneous ventilation randomly.

PROCEDUREspontaneous ventilation

patients are randomly divided to receive control or spontaneous ventilation randomly.

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

DIAGNOSTIC

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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.

Design outcomes

Primary

Measure	Time frame	Description
incidence of gastroesophageal reflux of participants	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

Contacts

Primary ContactZhenmeng Wang, Doctor

wzm11998@163.com+8613601919501

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026