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
1 other identifier
observational
360
1 country
2
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..
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jun 2011
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2011
CompletedFirst Submitted
Initial submission to the registry
June 28, 2011
CompletedFirst Posted
Study publicly available on registry
June 30, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2013
CompletedNovember 6, 2015
November 1, 2015
1.8 years
June 28, 2011
November 5, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Pressure of the syringe after inflation of the LMA cuff
after inflation, 1 hour into surgery
Secondary Outcomes (1)
Number of patients with dysphagia and/or dysphonia
1, 2, and 24 hours after surgery
Study Arms (3)
Standard Practice
Syringe recoil
Pressure Transducer
Interventions
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.
LMA cuff will be inflated per standard practice with a syringe and resulting cuff pressure will be measured by syringe recoil
LMA cuff will be inflated per standard practice with a syringe and resulting cuff pressure will be measured by pressure transducer.
Eligibility Criteria
Patients scheduled to undergo a surgical procedure less than 2 hours in duration
You may qualify if:
- 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)
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Mayo Cliniclead
Study Sites (2)
University of Florida College of Medicine
Gainesville, Florida, 32610, United States
Mayo Clinic
Jacksonville, Florida, 32224, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Christopher Robards, MD
Mayo Clinic
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- MD
Study Record Dates
First Submitted
June 28, 2011
First Posted
June 30, 2011
Study Start
June 1, 2011
Primary Completion
April 1, 2013
Study Completion
April 1, 2013
Last Updated
November 6, 2015
Record last verified: 2015-11