NCT02441257

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
200

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Aug 2015

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 25, 2015

Completed
4 months until next milestone

First Posted

Study publicly available on registry

May 12, 2015

Completed
3 months until next milestone

Study Start

First participant enrolled

August 1, 2015

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2016

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2016

Completed
Last Updated

May 12, 2015

Status Verified

May 1, 2015

Enrollment Period

11 months

First QC Date

January 25, 2015

Last Update Submit

May 11, 2015

Conditions

Gastroesophageal Reflux

Keywords

Gastroesophageal RefluxLaryngeal Mask AirwayControl VentilationSpontaneous Ventilation

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (1)

control ventilation

EXPERIMENTAL

patients are scheduled to receive control or spontaneous ventilation

Procedure: control ventilationProcedure: spontaneous ventilation

Interventions

control ventilationPROCEDURE

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

control ventilation
spontaneous ventilationPROCEDURE

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

control ventilation

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • patients for lower extremity operations;
  • patients for urological operations;
  • patients for gynecological operations.

You may not qualify if:

  • gastroesophageal reflux disease;
  • body mass index more than 30.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Gastroesophageal Reflux

Condition Hierarchy (Ancestors)

Esophageal Motility DisordersDeglutition DisordersEsophageal DiseasesGastrointestinal DiseasesDigestive System Diseases

Study Officials

  • Zhenmeng Wang, Doctor

    Eastern Hepatobiliary Surgery Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Zhenmeng Wang, Doctor

CONTACT

+8613601919501wzm11998@163.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Doctor

Study Record Dates

First Submitted

January 25, 2015

First Posted

May 12, 2015

Study Start

August 1, 2015

Primary Completion

July 1, 2016

Study Completion

October 1, 2016

Last Updated

May 12, 2015

Record last verified: 2015-05