IntubationPLMANCT01076725
Rotation Technique for the Insertion of the ProSeal Laryngeal Mask Airway in Pediatric Patients
A study testing Standard technique group and Rotation technique group in people with Intubation, run by Seoul National University Bundang Hospital.
Trial summary
Insertion of the ProSeal laryngeal mask airway in pediatric patients using the 90 degree rotational technique is more successful and causes less pharyngeal trauma than the standard technique in pediatric patients. Read more about this study
- Who is it for?
- Ages 3 to 9 years
- Conditions the study is for
- Intubation
- What is being tested?
- Standard technique group and Rotation technique group
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 63 participants
- Where
- No sites listed yet
- Study dates
- May 2009to Dec 2009
- 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 3 to 9 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Asian pediatric patients (age range 3-9 years; American Society of Anesthesiologists physical status I-II) who required general anesthesia with a PLMA for elective surgery.
Who cannot join
- Pediatric patient weighed less than 10 kg or over 50 kg, had congenital heart disease, respiratory disease or were at risk of aspiration.
About this study
Official title: Insertion of the ProSeal Laryngeal Mask Airway is More Successful With the 90 Degree Rotation Technique in Pediatric Patients: a Randomized Controlled Trial
Insertion of the ProSeal laryngeal mask airway in pediatric patients using the 90 degree rotational technique is more successful and causes less pharyngeal trauma than the standard technique in pediatric patients.
Read the detailed description
In our previous series of studies, we introduced a new, simple and effective 90 degree rotational insertion technique and the insertion success rate was great and less pain occurred with the rotational technique in adult. In this study, we investigated whether the 90 degree rotational technique will improve the insertion success rate than the standard technique in pediatric patients.
We hypothesized that the 90 degree rotational technique will improve the insertion success rate and decrease the complication of 2 to 3 size PLMA than the standard index finger insertion technique in children.
One hundred twenty six Asian pediatric patients were randomly allocated to a standard technique group or rotation technique group. The size of the PLMA was from 2 to 3 according to body weight of children. In the standard technique group (n = 63), the PLMA was inserted by index finger insertion technique. In the rotation technique group (n = 63), the entire cuff of the PLMA was placed in the mouth without finger insertion in a midline approach and was rotated 90 degrees counterclockwise around the tongue. The PLMA was then advanced and rotated back until resistance was felt.
The primary outcome was success at first insertion. Secondary outcome measures were insertion time and complications.
Success at first insertion was significantly higher for the rotation technique than the standard technique, and significantly less time was required. With the rotation technique, the incidence of PLMA repositioning and blood staining was significantly less than for the standard technique.
The rotational insertion technique for PLMA is more successful than the standard insertion technique and is associated with fewer blood staining on the PLMA which suggests that it causes less pharyngeal trauma in pediatric patients.
- Conditions
- Intubation
- Being tested
- Standard technique group, Rotation technique group
- Keywords
- ProSeal LMA, standard insertion, rotational insertion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard technique groupDevice
Also called Digital insertion group
In the standard technique group (n = 63), the PLMA was inserted by index finger insertion technique.
Rotation technique groupDevice
Also called 90 degree rotation insertion
The entire cuff of the PLMA was placed in the mouth without finger insertion in a midline approach and was rotated 90 degrees counterclockwise around the tongue. The PLMA was then advanced and rotated back until resistance was felt.
| Study group | Role | What they receive |
|---|---|---|
| Standard technique group | Active comparator | In the standard technique group(n = 63), the PLMA was inserted by index finger insertion technique. Receives: Device: Standard technique group |
| Rotation technique group | Experimental | The entire cuff of the PLMA was placed in the mouth without finger insertion in a midline approach and was rotated 90 degrees counterclockwise around the tongue. The PLMA was then advanced and rotated back until resistance was felt. Receives: Device: Rotation technique group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Insertion success rate at first attempt
% of success at first trial
Measured: 5 minute
Secondary outcomes (1)
Insertion time, sealing pressure and complication
Insertion time is an indices of the ease of insertion. Sealing pressure is an equilibrium airway pressure (maximum allowed = 40 cmH2O) when the expiratory valve of the breathing circuit was closed and a gas flow rate of 3 l/min was maintained. Blood on the surface of the cuff, incidence of postoperative sore throat or hoarseness are indices of complications.
Measured: 5 min-4 hrs
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Feb 2010 (estimated)
- Study startMay 2009
- Primary completionAug 2009
- Study completionDec 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for IntubationStudies 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
- Single blind
- Who is masked
- Care provider
- Enrolment
- 63 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seoul National University Bundang Hospital
- Sponsor type
- University, hospital or other
- Investigators
- Mija Yun, Professor, Principal investigator, Seoul National University Bundang Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01076725
- Sponsor's protocol ID
- SeoulNUBH
- Acronym
- PLMA
- Status last verified
- Apr 2009
- First submitted
- 25 Feb 2010
- Last updated
- 26 Feb 2010
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Hwang JW, Park HP, Lim YJ, Do SH, Lee SC, Jeon YT. Comparison of two insertion techniques of ProSeal laryngeal mask airway: standard versus 90-degree rotation. Anesthesiology. 2009 Apr;110(4):905-7. doi: 10.1097/ALN.0b013e31819b5d40.
PubMed 19293690Jeon YT, Na HS, Park SH, Oh AY, Park HP, Yun MJ, Kim JH, Hwang JW. Insertion of the ProSeal laryngeal mask airway is more successful with the 90 degrees rotation technique. Can J Anaesth. 2010 Mar;57(3):211-5. doi: 10.1007/s12630-009-9241-4. Epub 2010 Jan 15.
PubMed 20077171Yun MJ, Hwang JW, Park SH, Han SH, Park HP, Kim JH, Jeon YT, Lee SC. The 90 degrees rotation technique improves the ease of insertion of the ProSeal laryngeal mask airway in children. Can J Anaesth. 2011 Apr;58(4):379-83. doi: 10.1007/s12630-010-9452-8. Epub 2011 Jan 4.
PubMed 21203877
Study at a glance
From the registry record, last updated by the sponsor on 26 Feb 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Insertion of the ProSeal Laryngeal Mask Airway is More Successful With the 90 Degree Rotation Technique in Pediatric Patients: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT01076725
- Acronym / sponsor ID
- PLMA / SeoulNUBH
- Conditions
- Intubation
- Keywords
- ProSeal LMA, standard insertion, rotational insertion
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 63 participants (actual)
- Lead sponsor
- Seoul National University Bundang HospitalUniversity, hospital or other
- Study start
- May 2009
- Primary completion
- Aug 2009 (actual)
- Study completion
- Dec 2009 (actual)
- First posted
- 26 Feb 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.
Insertion of the ProSeal laryngeal mask airway in pediatric patients using the 90 degree rotational technique is more successful and causes less pharyngeal trauma than the standard technique in pediatric patients.
Detailed description
In our previous series of studies, we introduced a new, simple and effective 90 degree rotational insertion technique and the insertion success rate was great and less pain occurred with the rotational technique in adult. In this study, we investigated whether the 90 degree rotational technique will improve the insertion success rate than the standard technique in pediatric patients.
We hypothesized that the 90 degree rotational technique will improve the insertion success rate and decrease the complication of 2 to 3 size PLMA than the standard index finger insertion technique in children.
One hundred twenty six Asian pediatric patients were randomly allocated to a standard technique group or rotation technique group. The size of the PLMA was from 2 to 3 according to body weight of children. In the standard technique group (n = 63), the PLMA was inserted by index finger insertion technique. In the rotation technique group (n = 63), the entire cuff of the PLMA was placed in the mouth without finger insertion in a midline approach and was rotated 90 degrees counterclockwise around the tongue. The PLMA was then advanced and rotated back until resistance was felt.
The primary outcome was success at first insertion. Secondary outcome measures were insertion time and complications.
Success at first insertion was significantly higher for the rotation technique than the standard technique, and significantly less time was required. With the rotation technique, the incidence of PLMA repositioning and blood staining was significantly less than for the standard technique.
The rotational insertion technique for PLMA is more successful than the standard insertion technique and is associated with fewer blood staining on the PLMA which suggests that it causes less pharyngeal trauma in pediatric patients.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard technique group | Active comparator | Device: Standard technique groupIn the standard technique group(n = 63), the PLMA was inserted by index finger insertion technique. |
| Rotation technique group | Experimental | Device: Rotation technique groupThe entire cuff of the PLMA was placed in the mouth without finger insertion in a midline approach and was rotated 90 degrees counterclockwise around the tongue. The PLMA was then advanced and rotated back until resistance was felt. |
Who may qualify
- Ages
- 3 to 9 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Asian pediatric patients (age range 3-9 years; American Society of Anesthesiologists physical status I-II) who required general anesthesia with a PLMA for elective surgery.
Key exclusion criteria (1 listed)
- Pediatric patient weighed less than 10 kg or over 50 kg, had congenital heart disease, respiratory disease or were 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 |
|---|---|---|
| Standard technique groupAlso: Digital insertion groupIn the standard technique group (n = 63), the PLMA was inserted by index finger insertion technique. | Device | Standard technique group |
| Rotation technique groupAlso: 90 degree rotation insertionThe entire cuff of the PLMA was placed in the mouth without finger insertion in a midline approach and was rotated 90 degrees counterclockwise around the tongue. The PLMA was then advanced and rotated back until resistance was felt. | Device | Rotation technique group |
Primary outcome
Insertion success rate at first attempt
Time frame: 5 minute
% of success at first trial
1 secondary outcome
Insertion time, sealing pressure and complication
Time frame: 5 min-4 hrs
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 26 Feb 2010.
- Background: PubMed 19293690Hwang JW, Park HP, Lim YJ, Do SH, Lee SC, Jeon YT. Comparison of two insertion techniques of ProSeal laryngeal mask airway: standard versus 90-degree rotation. Anesthesiology. 2009 Apr;110(4):905-7. doi: 10.1097/ALN.0b013e31819b5d40.
- Background: PubMed 20077171Jeon YT, Na HS, Park SH, Oh AY, Park HP, Yun MJ, Kim JH, Hwang JW. Insertion of the ProSeal laryngeal mask airway is more successful with the 90 degrees rotation technique. Can J Anaesth. 2010 Mar;57(3):211-5. doi: 10.1007/s12630-009-9241-4. Epub 2010 Jan 15.
- Derived from this study: PubMed 21203877Yun MJ, Hwang JW, Park SH, Han SH, Park HP, Kim JH, Jeon YT, Lee SC. The 90 degrees rotation technique improves the ease of insertion of the ProSeal laryngeal mask airway in children. Can J Anaesth. 2011 Apr;58(4):379-83. doi: 10.1007/s12630-010-9452-8. Epub 2011 Jan 4.
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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.
Mija Yun, Professor principal investigator
Seoul National University Bundang Hospital
Questions about this trial
What is this clinical trial studying?
A study testing Standard technique group and Rotation technique group in people with Intubation, run by Seoul National University Bundang Hospital.
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 1 inclusion and 1 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 26 Feb 2010. Status can change between updates, so confirm with the study contact before making plans.
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?
Insertion success rate at first attempt (time frame: 5 minute). 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 NCT01076725, which also lists 3 linked publications.
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 26 Feb 2010.