Minor Urologic SurgeryNCT01836419
The Clinical Efficacy of Laryngeal Mask Airway in Elderly Patients: Comparison With Young Adults
A study testing classic LMA insertion in people with Minor Urologic Surgery and Lower Extremity Surgery, run by Yonsei University at 1 site in South Korea.
Trial summary
There are some differences between elderly and young adult patients regarding the anatomy of upper airways. Elderly patients have larger upper airways than young adult patients at all pharyngeal levels as revealed by CT. Read more about this study
- Who is it for?
- Ages 20 to 85 years
- Conditions the study is for
- Minor Urologic Surgery, Lower Extremity Surgery
- What is being tested?
- classic LMA insertion
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteSouth Korea
- Study dates
- Dec 2012to Nov 2013
- Phase
- Interventional
- 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 20 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients aged 20-40 and 65-85years
- ASA status 1-2
- Undergoing minor urologic surgery or lower extremity surgery
- Undergoing general anesthesia using classic LMA
Who cannot join
- Predicted difficult airway
- Increased risk of aspiration
- Gastroesophageal reflux
- Neuromuscular disease
- Significant acute or chronic lung disease
Trial locations and contacts
1 site in 1 country.
About this study
There are some differences between elderly and young adult patients regarding the anatomy of upper airways. Elderly patients have larger upper airways than young adult patients at all pharyngeal levels as revealed by CT. Another study explained that there is a progressive descent of the larynx and epiglottis with aging, which lengthens the upper airway and possibly makes it more likely to collapse.
The aim of this study is to compare the clinical efficacy of laryngeal mask airway (LMA) in elderly patients with young adults. In this study, the investigators will measure the ease of insertion, success rate of insertion, the time of insertion, oropharyngeal leak pressure, gastric leak pressure, fiberoptic position and intraoperative complications of the classic LMA.
- Conditions
- Minor Urologic Surgery, Lower Extremity Surgery
- Being tested
- classic LMA insertion
- Keywords
- classic laryngeal mask airway, elderly patients
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
classic LMA insertionProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| young adult group | Experimental | young adult patients undergoing minor urologic surgery or lower extremity surgery Receives: Procedure: classic LMA insertion |
| elderly group | Active comparator | elderly patients undergoing minor urologic surgery or lower extremity surgery Receives: Procedure: classic LMA insertion |
What is being measured
The primary outcome is the main question the study is designed to answer.
oropharyngeal leak pressure
After successful placement of LMA, airway leak pressure was determined by adjusting the expiratory valve of the breathing circle to 40 cmH2O(fixed fresh gas flow 3 L/min) and recording the pressure when equilibrium was reached.
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Apr 2013 (estimated)
- Study startDec 2012
- Primary completionNov 2013
- Study completionNov 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Minor Urologic SurgeryStudies of the same condition, open and under way.
- More trials run by Yonsei UniversityThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yonsei University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01836419
- Sponsor's protocol ID
- 4-2012-0711
- Status last verified
- Feb 2014
- First submitted
- 16 Apr 2013
- Last updated
- 19 Feb 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Feb 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Clinical Efficacy of Laryngeal Mask Airway in Elderly Patients: Comparison With Young Adults
- ClinicalTrials.gov ID
- NCT01836419
- Acronym / sponsor ID
- 4-2012-0711
- Conditions
- Minor Urologic Surgery, Lower Extremity Surgery
- Keywords
- classic laryngeal mask airway, elderly patients
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Yonsei UniversityUniversity, hospital or other
- Study start
- Dec 2012
- Primary completion
- Nov 2013 (actual)
- Study completion
- Nov 2013 (actual)
- First posted
- 19 Apr 2013 (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.
There are some differences between elderly and young adult patients regarding the anatomy of upper airways. Elderly patients have larger upper airways than young adult patients at all pharyngeal levels as revealed by CT. Another study explained that there is a progressive descent of the larynx and epiglottis with aging, which lengthens the upper airway and possibly makes it more likely to collapse.
The aim of this study is to compare the clinical efficacy of laryngeal mask airway (LMA) in elderly patients with young adults. In this study, the investigators will measure the ease of insertion, success rate of insertion, the time of insertion, oropharyngeal leak pressure, gastric leak pressure, fiberoptic position and intraoperative complications of the classic LMA.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| young adult group | Experimental | Procedure: classic LMA insertionyoung adult patients undergoing minor urologic surgery or lower extremity surgery |
| elderly group | Active comparator | Procedure: classic LMA insertionelderly patients undergoing minor urologic surgery or lower extremity surgery |
Who may qualify
- Ages
- 20 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients aged 20-40 and 65-85years
- ASA status 1-2
- Undergoing minor urologic surgery or lower extremity surgery
- Undergoing general anesthesia using classic LMA
Key exclusion criteria (5 listed)
- Predicted difficult airway
- Increased risk of aspiration
- Gastroesophageal reflux
- Neuromuscular disease
- Significant acute or chronic lung disease
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 |
|---|---|---|
| classic LMA insertion | Procedure or surgery | elderly group, young adult group |
Primary outcome
oropharyngeal leak pressure
Time frame: 24 hours
After successful placement of LMA, airway leak pressure was determined by adjusting the expiratory valve of the breathing circle to 40 cmH2O(fixed fresh gas flow 3 L/min) and recording the pressure when equilibrium was reached.
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 19 Feb 2014.
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing classic LMA insertion in people with Minor Urologic Surgery and Lower Extremity Surgery, run by Yonsei University at 1 site in South Korea.
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 5 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 19 Feb 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. 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?
oropharyngeal leak pressure (time frame: 24 hours). 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 19 Feb 2014.