LMA Cuff Pressure and LMA-induced Complications | NCT01385969

Studies
LMA Cuff Pressure and LMA-induced Complications

NCT01385969

Sponsor

Mayo Clinic

Status

Completed

Last Update Posted

Nov 6, 2015Estimated

Enrollment

360Actual

Phase

Not provided

Conditions

Sore Throat
Dysphagia
Dysphonia

Interventions

Standard inflation of LMA cuff
Pressure check with syringe recoil
Pressure check by pressure transducer

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Nov 2015

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 2011

Primary Completion Date

Apr 2013Actual

Completion Date

Apr 2013Actual

First Submitted Date

Jun 28, 2011

First Submission Date that Met QC Criteria

Jun 29, 2011

First Posted Date

Jun 30, 2011Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 5, 2015

Last Update Posted Date

Nov 6, 2015Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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..

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

360Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Standard Practice			Device: Standard inflation of LMA cuff
Syringe recoil			Device: Pressure check with syringe recoil
Pressure Transducer			Device: Pressure check by pressure transducer

Interventions

Name	Type	Description	Arm Group Labels	Other Names
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.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Pressure of the syringe after inflation of the LMA cuff		after inflation, 1 hour into surgery

Secondary Outcomes

Measure	Description	Time Frame
Number of patients with dysphagia and/or dysphonia		1, 2, and 24 hours after surgery

Other Outcomes

Not provided

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

99 Years

Standard Ages

AdultOlder Adult

Study Population

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

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Christopher Robards, MD	Mayo Clinic	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University of Florida College of Medicine		Gainesville	Florida	32610	United States
Mayo Clinic

Condition Browse Module

MeSH Terms

ID	Term
D010612	Pharyngitis
D003680	Deglutition Disorders
D055154	Dysphonia

Ancestor Terms

ID	Term
D012141	Respiratory Tract Infections
D007239	Infections
D010608	Pharyngeal Diseases
D009057	Stomatognathic Diseases

Browse Leaves

Not provided

Browse Branches

Not provided