Gastroesophageal RefluxLMANCT02441257
Gastroesophageal Reflux During LMA in Control Ventilation (LMA, Laryngeal Mask Airway)
A study testing spontaneous ventilation in people with Gastroesophageal Reflux, run by Zhenmeng Wang.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Gastroesophageal Reflux
- What is being tested?
- spontaneous ventilation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- No sites listed yet
- Study dates
- Aug 2015to Oct 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patients for lower extremity operations;
- patients for urological operations;
- patients for gynecological operations.
Who cannot join
- gastroesophageal reflux disease;
- body mass index more than 30.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: 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.
Read the 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.
- Conditions
- Gastroesophageal Reflux
- Being tested
- control ventilation, spontaneous ventilation
- Keywords
- Gastroesophageal Reflux, Laryngeal Mask Airway, Control Ventilation, Spontaneous Ventilation
- Medical subject headings
- Gastroesophageal Reflux
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
control ventilationProcedure or surgery
patients are randomly divided to receive control or spontaneous ventilation randomly.
spontaneous ventilationProcedure or surgery
patients are randomly divided to receive control or spontaneous ventilation randomly.
| Study group | Role | What they receive |
|---|---|---|
| control ventilation | Experimental | patients are scheduled to receive control or spontaneous ventilation Receives: Procedure: control ventilation; Procedure: spontaneous ventilation |
What is being measured
The primary outcome is the main question the study is designed to answer.
incidence of gastroesophageal reflux of participants
evaluate the exact incidence of reflux in LMA patients with catheter-based Digitrapper ph-Z monitor system
Measured: participants will be monitored for the duration of laryngeal mask application, an expected average of 1.5 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2015 (estimated)
- Study startAug 2015
- Primary completionJul 2016 (estimated)
- Study completionOct 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastroesophageal RefluxStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zhenmeng Wang
- Sponsor type
- University, hospital or other
- Collaborators
- Wake Forest University Health Sciences
- Responsible party
- Sponsor-investigator, Zhenmeng Wang, Eastern Hepatobiliary Surgery Hospital
- Investigators
- Zhenmeng Wang, Doctor, Principal investigator, Eastern Hepatobiliary Surgery Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02441257
- Sponsor's protocol ID
- EHBH
- Acronym
- LMA
- Status last verified
- May 2015
- First submitted
- 25 Jan 2015
- Last updated
- 12 May 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Incidence of Gastroesophageal Reflux During LMA Application in Control and Spontaneous Ventilation
- ClinicalTrials.gov ID
- NCT02441257
- Acronym / sponsor ID
- LMA / EHBH
- Conditions
- Gastroesophageal Reflux
- Keywords
- Gastroesophageal Reflux, Laryngeal Mask Airway, Control Ventilation, Spontaneous Ventilation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Zhenmeng WangUniversity, hospital or other
- Collaborators
- Wake Forest University Health Sciences
- Study start
- Aug 2015
- Primary completion
- Jul 2016 (estimated)
- Study completion
- Oct 2016 (estimated)
- First posted
- 12 May 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| control ventilation | Experimental | Procedure: control ventilation, Procedure: spontaneous ventilationpatients are scheduled to receive control or spontaneous ventilation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- patients for lower extremity operations;
- patients for urological operations;
- patients for gynecological operations.
Key exclusion criteria (2 listed)
- gastroesophageal reflux disease;
- body mass index more than 30.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| control ventilationpatients are randomly divided to receive control or spontaneous ventilation randomly. | Procedure or surgery | control ventilation |
| spontaneous ventilationpatients are randomly divided to receive control or spontaneous ventilation randomly. | Procedure or surgery | control ventilation |
Primary outcome
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 May 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Zhenmeng Wang, Doctor principal investigator
Eastern Hepatobiliary Surgery Hospital
Questions about this trial
What is this clinical trial studying?
A study testing spontaneous ventilation in people with Gastroesophageal Reflux, run by Zhenmeng Wang.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 12 May 2015. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Zhenmeng Wang, Doctor (+8613601919501, wzm11998@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 May 2015.