LMA Cuff Pressure and LMA-induced Complications

NCT ID: NCT01385969

Last Updated: 2015-11-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

360 participants

Study Classification

OBSERVATIONAL

Study Start Date

2011-06-30

Study Completion Date

2013-04-30

Brief Summary

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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..

Detailed Description

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Conditions

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Sore Throat Dysphagia Dysphonia

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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Standard Practice

Standard inflation of LMA cuff

Intervention Type DEVICE

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.

Syringe recoil

Pressure check with syringe recoil

Intervention Type DEVICE

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

Pressure Transducer

Pressure check by pressure transducer

Intervention Type DEVICE

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

Interventions

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Standard 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.

Intervention Type DEVICE

Pressure 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

Intervention Type DEVICE

Pressure 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.

Intervention Type DEVICE

Other Intervention Names

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LMA inflation routine clinical practice LMA cuff pressure by syringe recoil LMA cuff pressure checked by pressure transducer

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

99 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Mayo Clinic

OTHER

Sponsor Role lead

Responsible Party

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Christopher B. Robards

MD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Christopher Robards, MD

Role: PRINCIPAL_INVESTIGATOR

Mayo Clinic

Locations

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University of Florida College of Medicine

Gainesville, Florida, United States

Site Status

Mayo Clinic

Jacksonville, Florida, United States

Site Status

Countries

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United States

Other Identifiers

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11-001506

Identifier Type: -

Identifier Source: org_study_id

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