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LMA Cuff Pressure and LMA-induced Complications

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT01385969
Enrollment
360
Registered
2011-06-30
Start date
2011-06-30
Completion date
2013-04-30
Last updated
2015-11-06

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

Conditions

Dysphagia, Dysphonia, Sore Throat

Keywords

overinflation of LMAs

Brief summary

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..

Interventions

DEVICEStandard inflation of LMA cuff

LMA cuff will be inflated per standard practice with a syringe and resulting cuff pressure will be measured by manual palpation of the cuff per standard practice.

DEVICEPressure check with syringe recoil

LMA cuff will be inflated per standard practice with a syringe and resulting cuff pressure will be measured by syringe recoil

DEVICEPressure check by pressure transducer

LMA cuff will be inflated per standard practice with a syringe and resulting cuff pressure will be measured by pressure transducer.

Sponsors

Mayo Clinic
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 99 Years
Healthy volunteers
No

Inclusion criteria

* 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)

Exclusion criteria

* recent history of upper respiratory tract infection * intra-cavitary or laparoscopic procedure * risk of pulmonary aspiration * known difficult airway * history of gastric reflux * BMI \> 40 * lateral or prone positions * oral or nasal surgery

Design outcomes

Primary

MeasureTime frame
Pressure of the syringe after inflation of the LMA cuffafter inflation, 1 hour into surgery

Secondary

MeasureTime frame
Number of patients with dysphagia and/or dysphonia1, 2, and 24 hours after surgery

Countries

United States

Outcome results

None listed

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