LMA Cuff Pressure and LMA-induced Complications

Dysphagia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01385969
• Other study ID #: 11-001506
• Status: Completed
• Phase: N/A
• First received: June 28, 2011
• Last updated: November 5, 2015
• Start date: June 2011
• Est. completion date: April 2013

Study information

• Verified date: November 2015
• Source: Mayo Clinic
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationUnited States: Institutional Review Board
• Study type: Observational

Clinical Trial 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..

Recruitment information / eligibility

• Status: Completed
• Enrollment: 360
• Est. completion date: April 2013
• Est. primary completion date: April 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 99 Years

Eligibility

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 Design

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• Dysphagia
• Dysphonia
• Sore Throat

Intervention

Device:
• 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.
• 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
• 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.

Locations

Country	Name	City	State
United States	University of Florida College of Medicine	Gainesville	Florida
United States	Mayo Clinic	Jacksonville	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Mayo Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pressure of the syringe after inflation of the LMA cuff		after inflation, 1 hour into surgery	Yes
Secondary	Number of patients with dysphagia and/or dysphonia		1, 2, and 24 hours after surgery	No