General AnesthesiaNCT01843270
Appropriate Laryngeal Mask Airway Size in Patients With Overweight: A Comparison of the Actual Body Weight and Ideal Body Weight
A study testing actual body weight based size and ideal body weight based size in people with General Anesthesia, run by Yonsei University at 1 site in South Korea.
Trial summary
The classic laryngeal mask airway is one of the keystones of modern anaesthetic practice. It achieves a reliable airway with a low incidence of major complications and pharynges-laryngeal morbidity. The manufactures of laryngeal mask airway recommend the proper size selection by actual body weight. Read more about this study
- Who is it for?
- Ages 20 to 70 years
- Conditions the study is for
- General Anesthesia
- What is being tested?
- actual body weight based size and ideal body weight based size
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteSouth Korea
- Study dates
- Nov 2013to Sep 2014
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- age 20~70
- body mass index > 25 kg/m2
- patient who needs surgery with laryngeal mask airway
Who cannot join
- difficult airway
- upper airway infection or disease of airway
- history of gastroesophageal reflux
- history of head and neck surgery
Trial locations and contacts
1 site in 1 country.
About this study
The classic laryngeal mask airway is one of the keystones of modern anaesthetic practice. It achieves a reliable airway with a low incidence of major complications and pharynges-laryngeal morbidity. The manufactures of laryngeal mask airway recommend the proper size selection by actual body weight. It was recommended a size 3 for 30-70kg, a size 4 for 70-90 kg, and size 5 for > 90 kg. Obesity increases the fat tissue around an upper airway and decreases the pharyngeal cross sectional area. Also it was reported that pharyngeal area was reduced according to the increasing of BMI. Therefore, the aim of this study is to determine which of actual body weight or ideal body weight is proper on the size selection of laryngeal mask airway.
- Conditions
- General Anesthesia
- Being tested
- actual body weight based size, ideal body weight based size
- Keywords
- general anesthesia, body weight, laryngeal mask airway size
- Medical subject headings
- Body Weight
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
actual body weight based sizeDevice
According randomized allocated group, the laryngeal mask airway is inserted based on actual or ideal body weight-based sizes before the surgery.
ideal body weight based sizeDevice
According randomized allocated group, the laryngeal mask airway is inserted based on actual or ideal body weight-based sizes before the surgery.
| Study group | Role | What they receive |
|---|---|---|
| ideal body weight | Experimental | LMA size based on ideal body weight Receives: Device: ideal body weight based size |
| actual body weight | Experimental | LMA size according to actual body weight Receives: Device: actual body weight based size |
What is being measured
The primary outcome is the main question the study is designed to answer.
Oropharyngeal leak pressure
Oropharyngeal leak pressure is measured when the airway pressure becomes the plateau state in condition of gas flow 3 L/min and flow out valve 30 cmH2O.
Measured: 10mins
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Apr 2013 (estimated)
- Study startNov 2013
- Primary completionSep 2014
- Study completionSep 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for General AnesthesiaStudies 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
- Prevention
- Allocation
- 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
- NCT01843270
- Sponsor's protocol ID
- 1-2013-0004
- Status last verified
- Jan 2014
- First submitted
- 23 Apr 2013
- Last updated
- 29 Sep 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
Kim MS, Lee JS, Nam SB, Kang HJ, Kim JE. Randomized Comparison of Actual and Ideal Body Weight for Size Selection of the Laryngeal Mask Airway Classic in Overweight Patients. J Korean Med Sci. 2015 Aug;30(8):1197-202. doi: 10.3346/jkms.2015.30.8.1197. Epub 2015 Jul 15.
PubMed 26240500
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Appropriate Laryngeal Mask Airway Size in Patients With Overweight: A Comparison of the Actual Body Weight and Ideal Body Weight
- ClinicalTrials.gov ID
- NCT01843270
- Acronym / sponsor ID
- 1-2013-0004
- Conditions
- General Anesthesia
- Keywords
- general anesthesia, body weight, laryngeal mask airway size
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Yonsei UniversityUniversity, hospital or other
- Study start
- Nov 2013
- Primary completion
- Sep 2014 (actual)
- Study completion
- Sep 2014 (actual)
- First posted
- 30 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.
The classic laryngeal mask airway is one of the keystones of modern anaesthetic practice. It achieves a reliable airway with a low incidence of major complications and pharynges-laryngeal morbidity. The manufactures of laryngeal mask airway recommend the proper size selection by actual body weight. It was recommended a size 3 for 30-70kg, a size 4 for 70-90 kg, and size 5 for > 90 kg. Obesity increases the fat tissue around an upper airway and decreases the pharyngeal cross sectional area. Also it was reported that pharyngeal area was reduced according to the increasing of BMI. Therefore, the aim of this study is to determine which of actual body weight or ideal body weight is proper on the size selection of laryngeal mask airway.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ideal body weight | Experimental | Device: ideal body weight based sizeLMA size based on ideal body weight |
| actual body weight | Experimental | Device: actual body weight based sizeLMA size according to actual body weight |
Who may qualify
- Ages
- 20 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- age 20~70
- body mass index > 25 kg/m2
- patient who needs surgery with laryngeal mask airway
Key exclusion criteria (4 listed)
- difficult airway
- upper airway infection or disease of airway
- history of gastroesophageal reflux
- history of head and neck surgery
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 |
|---|---|---|
| actual body weight based sizeAccording randomized allocated group, the laryngeal mask airway is inserted based on actual or ideal body weight-based sizes before the surgery. | Device | actual body weight |
| ideal body weight based sizeAccording randomized allocated group, the laryngeal mask airway is inserted based on actual or ideal body weight-based sizes before the surgery. | Device | ideal body weight |
Primary outcome
Oropharyngeal leak pressure
Time frame: 10mins
Oropharyngeal leak pressure is measured when the airway pressure becomes the plateau state in condition of gas flow 3 L/min and flow out valve 30 cmH2O.
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 29 Sep 2014.
- Derived from this study: PubMed 26240500Kim MS, Lee JS, Nam SB, Kang HJ, Kim JE. Randomized Comparison of Actual and Ideal Body Weight for Size Selection of the Laryngeal Mask Airway Classic in Overweight Patients. J Korean Med Sci. 2015 Aug;30(8):1197-202. doi: 10.3346/jkms.2015.30.8.1197. Epub 2015 Jul 15.
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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.
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 actual body weight based size and ideal body weight based size in people with General Anesthesia, 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 3 inclusion and 4 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 29 Sep 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: 10mins). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01843270, which also lists 1 linked publication.
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 29 Sep 2014.