LMA Cuff Pressure and LMA-induced Complications

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Christopher B. Robards, Mayo Clinic
ClinicalTrials.gov Identifier:
NCT01385969
First received: June 28, 2011
Last updated: July 11, 2013
Last verified: July 2013
  Purpose

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..


Condition Intervention
Sore Throat
Dysphagia
Dysphonia
Device: Standard inflation of LMA cuff
Device: Pressure check with syringe recoil
Device: Pressure check by pressure transducer

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Using the Natural Recoil of the Inflating Syringe as a Safety Valve to Limit LMA Cuff Pressure and Decrease LMA-Induced Complications

Resource links provided by NLM:


Further study details as provided by Mayo Clinic:

Primary Outcome Measures:
  • Pressure of the syringe after inflation of the LMA cuff [ Time Frame: after inflation, 1 hour into surgery ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Number of patients with dysphagia and/or dysphonia [ Time Frame: 1, 2, and 24 hours after surgery ] [ Designated as safety issue: No ]

Enrollment: 360
Study Start Date: June 2011
Study Completion Date: April 2013
Primary Completion Date: April 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Standard Practice 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.
Other Name: LMA inflation routine clinical practice
Syringe recoil 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
Other Name: LMA cuff pressure by syringe recoil
Pressure Transducer 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.
Other Name: LMA cuff pressure checked by pressure transducer

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

Patients scheduled to undergo a surgical procedure less than 2 hours in duration

Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01385969

Locations
United States, Florida
University of Florida College of Medicine
Gainesville, Florida, United States, 32610
Mayo Clinic
Jacksonville, Florida, United States, 32224
Sponsors and Collaborators
Mayo Clinic
Investigators
Principal Investigator: Christopher Robards, MD Mayo Clinic
  More Information

No publications provided

Responsible Party: Christopher B. Robards, MD, Mayo Clinic
ClinicalTrials.gov Identifier: NCT01385969     History of Changes
Other Study ID Numbers: 11-001506
Study First Received: June 28, 2011
Last Updated: July 11, 2013
Health Authority: United States: Food and Drug Administration
United States: Institutional Review Board

Keywords provided by Mayo Clinic:
overinflation of LMAs

ClinicalTrials.gov processed this record on October 23, 2014