Completed

Using the Natural Recoil of the Inflating Syringe as a Safety Valve to Limit LMA Cuff Pressure and Decrease LMA-Induced Complications

0 criteria met from your profileSee at a glance how your profile meets each eligibility criteria.
What is being collected

Data Collection

Collected from today forward - Prospective
Who is being recruted

Deglutition Disorders+15

+ Digestive System Diseases

+ Esophageal Diseases

From 18 to 99 Years
+12 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Case-Control

Comparing exposures between individuals with and without disease in order to identify potential risk factors.
Observational
Study Start: June 2011
See protocol details

Summary

Principal SponsorMayo Clinic
Last updated: January 27, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: June 1, 2011

Actual date on which the first participant was enrolled.

The purpose of this study is to determine if using 20 mL B.Braun syringes to inflate LMAs and allowing them to recoil will put the pressure of the LMA cuff within the safety range. It will also determine if remaining within this safety range has an effect on complications after surgery..

Official TitleUsing the Natural Recoil of the Inflating Syringe as a Safety Valve to Limit LMA Cuff Pressure and Decrease LMA-Induced Complications
NCT01385969
Principal SponsorMayo Clinic
Last updated: January 27, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

360 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Case-Control

These studies compare people who have a disease (cases) with those who don't (controls). The goal is to look back at previous exposures or risk factors to identify what might have contributed to the disease.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 18 to 99 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Deglutition DisordersDigestive System DiseasesEsophageal DiseasesGastrointestinal DiseasesInfectionsLaryngeal DiseasesStomatognathic DiseasesNervous System DiseasesNeurologic ManifestationsOtorhinolaryngologic DiseasesPharyngeal DiseasesPharyngitisRespiratory Tract DiseasesRespiratory Tract InfectionsSigns and SymptomsPathological Conditions, Signs and SymptomsVoice DisordersDysphonia

Criteria

4 inclusion criteria required to participate
Registered Mayo Clinic in Florida patients scheduled to undergo a surgery
Planned use of LMA during surgery
between the ages of 18-99
short duration (<2 hours elective surgery)
8 exclusion criteria prevent from participating
recent history of upper respiratory tract infection
intra-cavitary or laparoscopic procedure
risk of pulmonary aspiration
known difficult airway
Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Study Objectives

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 2 locations

Suspended

University of Florida College of Medicine

Gainesville, United StatesOpen University of Florida College of Medicine in Google Maps
Suspended

Mayo Clinic

Jacksonville, United States
Completed2 Study Centers