Skip to main content
OpenTrials
Completed

NCT Number: NCT01385969

LMA Cuff Pressure and LMA-induced Complications

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..

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Sore Throat Deglutition Disorders Digestive System Diseases Dysphagia Dysphonia Esophageal Diseases Gastrointestinal Diseases Infections Laryngeal Diseases Nervous System Diseases Neurologic Manifestations Otorhinolaryngologic Diseases Pathological Conditions, Signs and Symptoms Pharyngeal Diseases Pharyngitis Respiratory Tract Diseases Respiratory Tract Infections Signs and Symptoms Stomatognathic Diseases Voice Disorders

Age range

18 year–99 year

Sex eligibility

All sexes

Study type

Observational

Primary location

University of Florida College of Medicine, Gainesville, Florida, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Standard inflation of LMA cuff

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.

Other names: LMA inflation routine clinical practice

Pressure check with syringe recoil

Device

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

Other names: LMA cuff pressure by syringe recoil

Pressure check by pressure transducer

Device

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

Other names: LMA cuff pressure checked by pressure transducer

Primary outcomes

  1. Pressure of the syringe after inflation of the LMA cuff

    Time frame: after inflation, 1 hour into surgery

Secondary outcomes

  1. Number of patients with dysphagia and/or dysphonia

    Time frame: 1, 2, and 24 hours after surgery

Sponsors and collaborators

Lead sponsor

Mayo Clinic

Other

Registry information

Official study title

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

Important dates

Study start
2011
Primary completion
2013
Study completion
2013
First posted
Jun 30, 2011
Registry last updated
Nov 6, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.