- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01385969
LMA Cuff Pressure and LMA-induced Complications
November 5, 2015 updated by: Christopher B. Robards, Mayo Clinic
Using the Natural Recoil of the Inflating Syringe as a Safety Valve to Limit LMA Cuff Pressure and Decrease 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..
Study Overview
Status
Completed
Conditions
Study Type
Observational
Enrollment (Actual)
360
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Florida
-
Gainesville, Florida, United States, 32610
- University of Florida College of Medicine
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Jacksonville, Florida, United States, 32224
- Mayo Clinic
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 99 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Probability Sample
Study Population
Patients scheduled to undergo a surgical procedure less than 2 hours in duration
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Standard Practice
|
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:
|
Syringe recoil
|
LMA cuff will be inflated per standard practice with a syringe and resulting cuff pressure will be measured by syringe recoil
Other Names:
|
Pressure Transducer
|
LMA cuff will be inflated per standard practice with a syringe and resulting cuff pressure will be measured by pressure transducer.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Pressure of the syringe after inflation of the LMA cuff
Time Frame: after inflation, 1 hour into surgery
|
after inflation, 1 hour into surgery
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Number of patients with dysphagia and/or dysphonia
Time Frame: 1, 2, and 24 hours after surgery
|
1, 2, and 24 hours after surgery
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
June 1, 2011
Primary Completion (Actual)
April 1, 2013
Study Completion (Actual)
April 1, 2013
Study Registration Dates
First Submitted
June 28, 2011
First Submitted That Met QC Criteria
June 29, 2011
First Posted (Estimate)
June 30, 2011
Study Record Updates
Last Update Posted (Estimate)
November 6, 2015
Last Update Submitted That Met QC Criteria
November 5, 2015
Last Verified
November 1, 2015
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 11-001506
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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