Airway ManagementNCT01191619
Comparison of Two Insertion Techniques of Proseal Laryngeal Mask Airway by Unskilled Personnel in Children
A study testing McIvor retractor in people with Airway Management, run by Seoul National University Bundang Hospital at 1 site in South Korea.
Trial summary
The ProSeal laryngeal mask airway (PLMA) is one of the alternative methods for effective airway management. It is an advanced form of laryngeal mask airway(LMA) with a softer and larger cuff to improve sealing and a drain tube to permit venting of the stomach. Read more about this study
- Who is it for?
- Ages 3 to 9 years
- Conditions the study is for
- Airway Management
- What is being tested?
- McIvor retractor
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 134 participants
- Where
- 1 siteSouth Korea
- Study dates
- Jul 2010to Dec 2010
- 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
- healthy pediatric patients undergoing surgery under general anesthesia
Who cannot join
- pediatric patients with a known or predicted difficult airway, recent sore throat, mouth opening less than 2.5 cm, or at risk of aspiration
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Seoul National University Bundang Hospital
Gyeonggi-do, 463-707
Jin-Young Hwang, MD, 82-16-746-4750, mistyblue15@naver.com
Jin-Young Hwang, MD
About this study
The ProSeal laryngeal mask airway (PLMA) is one of the alternative methods for effective airway management. It is an advanced form of laryngeal mask airway(LMA) with a softer and larger cuff to improve sealing and a drain tube to permit venting of the stomach. However, the larger cuff is more difficult to save space for insertion in the mouth and is more likely to fold over. Particularly, a relatively large tongue, a floppy epiglottis, a cephalad and more anterior larynx and frequent presence of tonsillar hypertrophy may disturb PLMA insertion in pediatric patients. The manufacturer recommends inserting PLMA using digital manipulation or with an introducer, but these techniques have lower success rates compared to those of LMA insertion.
McIvor blade is a tongue retractor with a thin and curved blade and a flat handle. It is used to secure the operating field by pressing tongue during tonsillectomy. The investigators hypothesized that McIvor blade would provide more space in the mouth for PLMA insertion, and therefore it could improve the PLMA insertion as well as reducing injuries to the pharyngeal wall. The investigators compared the success rate and the incidence of complications of the digital technique with those of McIvor blade-guided insertion by unskilled anesthesia residents.
Read the detailed description
Rapid and successful airway management is important for the patient's outcome in emergency care. Tracheal intubation with an endotracheal tube is the gold standard for airway management, but tracheal intubation by paramedical staff in pre-hospital setting can be time-consuming and difficult. The ProSealTM laryngeal mask airway (PLMA) is one of the alternative methods for effective airway management. It is an advanced form of laryngeal mask airway(LMA) with a softer and larger cuff to improve sealing and a drain tube to permit venting of the stomach. However, the larger cuff is more difficult to save space for insertion in the mouth and is more likely to fold over. Particularly, a relatively large tongue, a floppy epiglottis, a cephalad and more anterior larynx and frequent presence of tonsillar hypertrophy may disturb PLMA insertion in pediatric patients. The manufacturer recommends inserting PLMA using digital manipulation or with an introducer, but these techniques have lower success rates compared to those of LMA insertion. The first attempt success rate of PLMA insertion by inexperienced personnel was reported to be 83%. Several techniques have been introduced to improve the insertion success rate; the use of fiberoscopy, gum-elastic bougie, and a suction catheter. However, all of them can not save enough oral space for PLMA insertion and it would not be easy for the unskilled personnel to use them in emergency situations. A larger space between tongue and retropharynx, not being accompanied with an index finger for insertion would make make it easier for the unskilled personnel to insert the PLMA.
McIvor blade is a tongue retractor with a thin and curved blade and a flat handle. It is used to secure the operating field by pressing tongue during tonsillectomy. We hypothesized that McIvor blade would provide more space in the mouth for PLMA insertion, and therefore it could improve the PLMA insertion as well as reducing injuries to the pharyngeal wall. We compared the success rate and the incidence of complications of the digital technique with those of McIvor blade-guided insertion by unskilled anesthesia residents.
- Conditions
- Airway Management
- Being tested
- McIvor retractor
- Keywords
- McIvor retractor, Proseal laryngeal mask airway
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
McIvor retractorProcedure or surgery
Also called McIvor group
The Mclvor blade- guided technique (McIvor group) involved the following steps. The PLMA was lubricated on the posterior aspect of the deflated mask with a water-based lubricant. The McIvor blade was fully inserted beneath the tongue of the patients. The tongue was lifted gently with the McIvor blade and PLMA was introduced into a space between the McIvor blade and maxillary incisors holding the bite block of the PLMA. The PLMA was advanced into the hypopharynx until definite resistance was felt and McIvor blade was removed.
| Study group | Role | What they receive |
|---|---|---|
| McIvor group | Experimental | groups in which proseal laryngeal mask airway is inserted with McIvor retractor. Receives: Procedure: McIvor retractor |
What is being measured
The primary outcome is the main question the study is designed to answer.
the success rate of proseal laryngeal mask airway (PLMA) insertion
immediately after the insertion of PLMA
Measured: at the time of insertion of PLMA
Secondary outcomes (1)
the incidence of complications following PLMA insertion
blood staining: after the removal of PLMA; sore throat: 1 day after surgery
Measured: after the removal of PLMA, and 1 day after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2010 (estimated)
- Study startJul 2010
- Primary completionDec 2010 (estimated)
- Study completionDec 2010 (estimated)
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 Airway ManagementStudies 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
- Outcomes assessor
- Enrolment
- 134 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Seoul National University Bundang Hospital
- Sponsor type
- University, hospital or other
- Investigators
- Jin-Young Hwang, MD, Principal investigator, Fellow
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01191619
- Sponsor's protocol ID
- B1006/104-004
- Status last verified
- Jul 2010
- First submitted
- 5 Aug 2010
- Last updated
- 31 Aug 2010
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Hwang J, Han S, Hwang J, Oh A, Park S, Kim J. The McIvor blade improves insertion of the LMA ProSeal in children. Can J Anaesth. 2011 Sep;58(9):796-801. doi: 10.1007/s12630-011-9540-4. Epub 2011 Jun 21.
PubMed 21691935
Study at a glance
From the registry record, last updated by the sponsor on 31 Aug 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Two Insertion Techniques of Proseal Laryngeal Mask Airway by Unskilled Personnel in Children
- ClinicalTrials.gov ID
- NCT01191619
- Acronym / sponsor ID
- B1006/104-004
- Conditions
- Airway Management
- Keywords
- McIvor retractor, Proseal laryngeal mask airway
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 134 participants (estimated)
- Lead sponsor
- Seoul National University Bundang HospitalUniversity, hospital or other
- Study start
- Jul 2010
- Primary completion
- Dec 2010 (estimated)
- Study completion
- Dec 2010 (estimated)
- First posted
- 31 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 ProSeal laryngeal mask airway (PLMA) is one of the alternative methods for effective airway management. It is an advanced form of laryngeal mask airway(LMA) with a softer and larger cuff to improve sealing and a drain tube to permit venting of the stomach. However, the larger cuff is more difficult to save space for insertion in the mouth and is more likely to fold over. Particularly, a relatively large tongue, a floppy epiglottis, a cephalad and more anterior larynx and frequent presence of tonsillar hypertrophy may disturb PLMA insertion in pediatric patients. The manufacturer recommends inserting PLMA using digital manipulation or with an introducer, but these techniques have lower success rates compared to those of LMA insertion.
McIvor blade is a tongue retractor with a thin and curved blade and a flat handle. It is used to secure the operating field by pressing tongue during tonsillectomy. The investigators hypothesized that McIvor blade would provide more space in the mouth for PLMA insertion, and therefore it could improve the PLMA insertion as well as reducing injuries to the pharyngeal wall. The investigators compared the success rate and the incidence of complications of the digital technique with those of McIvor blade-guided insertion by unskilled anesthesia residents.
Detailed description
Rapid and successful airway management is important for the patient's outcome in emergency care. Tracheal intubation with an endotracheal tube is the gold standard for airway management, but tracheal intubation by paramedical staff in pre-hospital setting can be time-consuming and difficult. The ProSealTM laryngeal mask airway (PLMA) is one of the alternative methods for effective airway management. It is an advanced form of laryngeal mask airway(LMA) with a softer and larger cuff to improve sealing and a drain tube to permit venting of the stomach. However, the larger cuff is more difficult to save space for insertion in the mouth and is more likely to fold over. Particularly, a relatively large tongue, a floppy epiglottis, a cephalad and more anterior larynx and frequent presence of tonsillar hypertrophy may disturb PLMA insertion in pediatric patients. The manufacturer recommends inserting PLMA using digital manipulation or with an introducer, but these techniques have lower success rates compared to those of LMA insertion. The first attempt success rate of PLMA insertion by inexperienced personnel was reported to be 83%. Several techniques have been introduced to improve the insertion success rate; the use of fiberoscopy, gum-elastic bougie, and a suction catheter. However, all of them can not save enough oral space for PLMA insertion and it would not be easy for the unskilled personnel to use them in emergency situations. A larger space between tongue and retropharynx, not being accompanied with an index finger for insertion would make make it easier for the unskilled personnel to insert the PLMA.
McIvor blade is a tongue retractor with a thin and curved blade and a flat handle. It is used to secure the operating field by pressing tongue during tonsillectomy. We hypothesized that McIvor blade would provide more space in the mouth for PLMA insertion, and therefore it could improve the PLMA insertion as well as reducing injuries to the pharyngeal wall. We compared the success rate and the incidence of complications of the digital technique with those of McIvor blade-guided insertion by unskilled anesthesia residents.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| McIvor group | Experimental | Procedure: McIvor retractorgroups in which proseal laryngeal mask airway is inserted with McIvor retractor. |
Who may qualify
- Ages
- 3 to 9 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- healthy pediatric patients undergoing surgery under general anesthesia
Key exclusion criteria (1 listed)
- pediatric patients with a known or predicted difficult airway, recent sore throat, mouth opening less than 2.5 cm, or 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 |
|---|---|---|
| McIvor retractorAlso: McIvor groupThe Mclvor blade- guided technique (McIvor group) involved the following steps. The PLMA was lubricated on the posterior aspect of the deflated mask with a water-based lubricant. The McIvor blade was fully inserted beneath the tongue of the patients. The tongue was lifted gently with the McIvor blade and PLMA was introduced into a space between the McIvor blade and maxillary incisors holding the bite block of the PLMA. The PLMA was advanced into the hypopharynx until definite resistance was felt and McIvor blade was removed. | Procedure or surgery | McIvor group |
Primary outcome
the success rate of proseal laryngeal mask airway (PLMA) insertion
Time frame: at the time of insertion of PLMA
immediately after the insertion of PLMA
1 secondary outcome
the incidence of complications following PLMA insertion
Time frame: after the removal of PLMA, and 1 day after surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Aug 2010.
- Derived from this study: PubMed 21691935Hwang J, Han S, Hwang J, Oh A, Park S, Kim J. The McIvor blade improves insertion of the LMA ProSeal in children. Can J Anaesth. 2011 Sep;58(9):796-801. doi: 10.1007/s12630-011-9540-4. Epub 2011 Jun 21.
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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.
Jin-Young Hwang, MD principal investigator
Fellow
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing McIvor retractor in people with Airway Management, 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 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: status not confirmed, as of the sponsor's last update on 31 Aug 2010. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jin-Young Hwang, MD (82-16-746-4750, mistyblue15@naver.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the success rate of proseal laryngeal mask airway (PLMA) insertion (time frame: at the time of insertion of PLMA). 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 NCT01191619, 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 31 Aug 2010.