Oropharyngeal InjuryNCT01184677
ProSeal Laryngeal Mask Airway (LMA) Size 3 vs 4 in Non-paralyzed Female Patients
A study testing insertion of the ProSeal LMA (PLMA) and insertion of the PLMA in people with Oropharyngeal Injury, run by Seoul National University Bundang Hospital at 1 site in South Korea.
Trial summary
The investigators hypothesize that ProSeal laryngeal mask airway (PLMA) of smaller size would reduce the incidence of mucosal injury. Read more about this study
- Who is it for?
- Ages 18 to 80 years, women only
- Conditions the study is for
- Oropharyngeal Injury
- What is being tested?
- insertion of the ProSeal LMA (PLMA) and insertion of the PLMA
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 154 participants
- Where
- 1 siteSouth Korea
- Study dates
- Aug 2010to Feb 2012
- 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 18 to 80 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- female
- aged 18-80 yr
- American Society of Anesthesiologists physical status Ⅰ-Ⅱ
- scheduled to undergo short outpatient gynecological procedures using ProSealTM LMA (PLMA) for anesthesia
Who cannot join
- a known or predicted difficult airway
- recent sore throat
- mouth opening less than 2.5 cm
- body mass index > 35 kg/m2
- at risk of aspiration.
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Seoul National University Bundang Hospital
Seongnam-si, Gyeonggi-do, 463-707
About this study
Official title: Comparison of the Size 3 ProsealTM Laryngeal Mask Airway Versus Size 4 in Anaesthetized, Non-paralyzed Women: A Randomised Controlled Trial
The investigators hypothesize that ProSeal laryngeal mask airway (PLMA) of smaller size would reduce the incidence of mucosal injury.
Read the detailed description
The ProSealTM laryngeal mask airway (PLMA; Laryngeal Mask Co. Limited, Mahe, Seychelles) is a laryngeal mask device with an added dorsal cuff to improve the seal and a drainage tube to prevent aspiration and gastric insufflations(Brain, Verghese et al. 2000).Despite its utility, there are complications associated with PLMA insertion such as sore throat and mucosal injury including oropharyngeal blood.
The purpose of this randomized controlled study is to determine if size 3 PLMA would induce less mucosal damage indicated by blood on the cuff than size 4 in non-paralyzed female patients. The secondary objective of this study is to compare insertion time, number of attempts, oropharyngeal leak pressure, hemodynamic variables, and incidence of complications with size 3 and 4 PLMA.
- Conditions
- Oropharyngeal Injury
- Being tested
- insertion of the ProSeal LMA (PLMA), insertion of the PLMA
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
insertion of the ProSeal LMA (PLMA)Device
Also called insertion, ProSeal LMA size 3
ProSeal LMA size 3 is inserted to the patients of Group size 3.
insertion of the PLMADevice
Also called insertion, ProSeal LMA size 4
ProSeal LMA size 4 is inserted to the patients of Group size 4.
| Study group | Role | What they receive |
|---|---|---|
| Group size 4 | Placebo comparator | Not described Receives: Device: insertion of the PLMA |
| Group size 3 | Experimental | ProSeal LMA size 3 is inserted to the patients of Group size 3. Receives: Device: insertion of the ProSeal LMA (PLMA) |
What is being measured
The primary outcome is the main question the study is designed to answer.
blood on the ProSeal LMA
The incidence of blood on the proseal LMA upon removal of the device is assessed in each group.
Measured: from the start of ProSeal LMA insertion until the end of the anesthesia (around 30min , mostly less than 60min)
Secondary outcomes (5)
hemodynamic variables
mean arterial pressure and heart rate before and after the Proseal LMA insertion are measured.
Measured: from induction of anesthesia until immediately after the Proseal LMA insertion
insertion time
Measured: from grasping the Proseal LMA until an effective airway is established
seal pressure
oropharyngeal leak pressure
Measured: after successful insertion of Proseal LMA
other intraoperative complications
airway leak, failed ventilation, regurgitation/aspiration, laryngospasm, cough/gag/retching/hiccup.
Measured: from successful insertion of PLMA until the end of the anesthesia
postoperative complications
sore throat and hoarseness
Measured: from removal of Proseal LMA until discharge from recovery room
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2010 (estimated)
- Study startAug 2010
- Primary completionDec 2011
- Study completionFeb 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Oropharyngeal InjuryStudies of the same condition, open and under way.
- More trials run by Seoul National University Bundang HospitalThe 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
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 154 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seoul National University Bundang Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kim Mihyun, Seoul National University Bundang Hospital
- Investigators
- Mihyun Kim, professor, Principal investigator, Seoul National University Bundang Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01184677
- Sponsor's protocol ID
- ProSeal LMA 3 vs 4
- Status last verified
- Aug 2012
- First submitted
- 18 Aug 2010
- Last updated
- 27 Aug 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 27 Aug 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Size 3 ProsealTM Laryngeal Mask Airway Versus Size 4 in Anaesthetized, Non-paralyzed Women: A Randomised Controlled Trial
- ClinicalTrials.gov ID
- NCT01184677
- Acronym / sponsor ID
- ProSeal LMA 3 vs 4
- Conditions
- Oropharyngeal Injury
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 154 participants (actual)
- Lead sponsor
- Seoul National University Bundang HospitalUniversity, hospital or other
- Study start
- Aug 2010
- Primary completion
- Dec 2011 (actual)
- Study completion
- Feb 2012 (actual)
- First posted
- 19 Aug 2010 (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 investigators hypothesize that ProSeal laryngeal mask airway (PLMA) of smaller size would reduce the incidence of mucosal injury.
Detailed description
The ProSealTM laryngeal mask airway (PLMA; Laryngeal Mask Co. Limited, Mahe, Seychelles) is a laryngeal mask device with an added dorsal cuff to improve the seal and a drainage tube to prevent aspiration and gastric insufflations(Brain, Verghese et al. 2000).Despite its utility, there are complications associated with PLMA insertion such as sore throat and mucosal injury including oropharyngeal blood.
The purpose of this randomized controlled study is to determine if size 3 PLMA would induce less mucosal damage indicated by blood on the cuff than size 4 in non-paralyzed female patients. The secondary objective of this study is to compare insertion time, number of attempts, oropharyngeal leak pressure, hemodynamic variables, and incidence of complications with size 3 and 4 PLMA.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group size 4 | Placebo comparator | Device: insertion of the PLMA |
| Group size 3 | Experimental | Device: insertion of the ProSeal LMA (PLMA)ProSeal LMA size 3 is inserted to the patients of Group size 3. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- female
- aged 18-80 yr
- American Society of Anesthesiologists physical status Ⅰ-Ⅱ
- scheduled to undergo short outpatient gynecological procedures using ProSealTM LMA (PLMA) for anesthesia
Key exclusion criteria (5 listed)
- a known or predicted difficult airway
- recent sore throat
- mouth opening less than 2.5 cm
- body mass index > 35 kg/m2
- at risk of aspiration.
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 |
|---|---|---|
| insertion of the ProSeal LMA (PLMA)Also: insertion, ProSeal LMA size 3ProSeal LMA size 3 is inserted to the patients of Group size 3. | Device | Group size 3 |
| insertion of the PLMAAlso: insertion, ProSeal LMA size 4ProSeal LMA size 4 is inserted to the patients of Group size 4. | Device | Group size 4 |
Primary outcome
blood on the ProSeal LMA
Time frame: from the start of ProSeal LMA insertion until the end of the anesthesia (around 30min , mostly less than 60min)
The incidence of blood on the proseal LMA upon removal of the device is assessed in each group.
5 secondary outcomes
hemodynamic variables
Time frame: from induction of anesthesia until immediately after the Proseal LMA insertion
insertion time
Time frame: from grasping the Proseal LMA until an effective airway is established
seal pressure
Time frame: after successful insertion of Proseal LMA
other intraoperative complications
Time frame: from successful insertion of PLMA until the end of the anesthesia
postoperative complications
Time frame: from removal of Proseal LMA until discharge from recovery room
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 27 Aug 2012.
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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.
Mihyun Kim, professor principal investigator
Seoul National University Bundang Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing insertion of the ProSeal LMA (PLMA) and insertion of the PLMA in people with Oropharyngeal Injury, run by Seoul National University Bundang Hospital 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 27 Aug 2012. 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. Some participants in this study may receive a placebo. 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?
blood on the ProSeal LMA (time frame: from the start of ProSeal LMA insertion until the end of the anesthesia (around 30min , mostly less than 60min)). 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 27 Aug 2012.