Sore ThroatNCT01385969
LMA Cuff Pressure and LMA-induced Complications
An observational study of Sore Throat and Dysphagia, run by Mayo Clinic at 2 sites in United States.
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.. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Sore Throat, Dysphagia, Dysphonia
- What is being tested?
- Standard inflation of LMA cuff, Pressure check with syringe recoil and Pressure check by pressure transducer
- Type of treatment
- Injection or infusion, Medical device
- How many people
- 360 participants
- Where
- 2 sitesUnited States
- Study dates
- Jun 2011to Apr 2013
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients scheduled to undergo a surgical procedure less than 2 hours in duration
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
United States2 sites
University of Florida College of Medicine
Gainesville, Florida, 32610
Mayo Clinic
Jacksonville, Florida, 32224
About this study
Official title: 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..
- Conditions
- Sore Throat, Dysphagia, Dysphonia
- Being tested
- Standard inflation of LMA cuff, Pressure check with syringe recoil, Pressure check by pressure transducer
- Keywords
- overinflation of LMAs
- Medical subject headings
- Pharyngitis, Deglutition Disorders, Dysphonia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard inflation of LMA cuffDevice
Also called LMA inflation routine clinical 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.
Pressure check with syringe recoilDevice
Also called LMA cuff pressure by 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 transducerDevice
Also called LMA cuff pressure checked by pressure transducer
LMA cuff will be inflated per standard practice with a syringe and resulting cuff pressure will be measured by pressure transducer.
| Study group | Role | What they receive |
|---|---|---|
| Standard Practice | Not described Receives: Device: Standard inflation of LMA cuff | |
| Syringe recoil | Not described Receives: Device: Pressure check with syringe recoil | |
| Pressure Transducer | Not described Receives: Device: Pressure check by pressure transducer |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pressure of the syringe after inflation of the LMA cuff
Measured: after inflation, 1 hour into surgery
Secondary outcomes (1)
Number of patients with dysphagia and/or dysphonia
Measured: 1, 2, and 24 hours after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jun 2011 (estimated)
- Study startJun 2011
- Primary completionApr 2013
- Study completionApr 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sore ThroatStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 360 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Christopher B. Robards, Mayo Clinic
- Investigators
- Christopher Robards, MD, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01385969
- Sponsor's protocol ID
- 11-001506
- Status last verified
- Nov 2015
- First submitted
- 28 Jun 2011
- Last updated
- 6 Nov 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Using the Natural Recoil of the Inflating Syringe as a Safety Valve to Limit LMA Cuff Pressure and Decrease LMA-Induced Complications
- ClinicalTrials.gov ID
- NCT01385969
- Acronym / sponsor ID
- 11-001506
- Conditions
- Sore Throat, Dysphagia, Dysphonia
- Keywords
- overinflation of LMAs
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 360 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- Jun 2011
- Primary completion
- Apr 2013 (actual)
- Study completion
- Apr 2013 (actual)
- First posted
- 30 Jun 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Standard Practice | – | Device: Standard inflation of LMA cuff |
| Syringe recoil | – | Device: Pressure check with syringe recoil |
| Pressure Transducer | – | Device: Pressure check by pressure transducer |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients scheduled to undergo a surgical procedure less than 2 hours in duration
Key inclusion criteria (4 listed)
- 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)
Key exclusion criteria (8 listed)
- recent history of upper respiratory tract infection
- intra-cavitary or laparoscopic procedure
- risk of pulmonary aspiration
- known difficult airway
- history of gastric reflux
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Standard inflation of LMA cuffAlso: LMA inflation routine clinical practiceLMA 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. | Device | Standard Practice |
| Pressure check with syringe recoilAlso: LMA cuff pressure by syringe recoilLMA cuff will be inflated per standard practice with a syringe and resulting cuff pressure will be measured by syringe recoil | Device | Syringe recoil |
| Pressure check by pressure transducerAlso: LMA cuff pressure checked by pressure transducerLMA cuff will be inflated per standard practice with a syringe and resulting cuff pressure will be measured by pressure transducer. | Device | Pressure Transducer |
Primary outcome
Pressure of the syringe after inflation of the LMA cuff
Time frame: after inflation, 1 hour into surgery
1 secondary outcome
Number of patients with dysphagia and/or dysphonia
Time frame: 1, 2, and 24 hours after surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Nov 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Christopher Robards, MD principal investigator
Mayo Clinic
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Sore Throat and Dysphagia, run by Mayo Clinic at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Nov 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pressure of the syringe after inflation of the LMA cuff (time frame: after inflation, 1 hour into surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Nov 2015.