Comparison of Two Insertion Techniques of Proseal Laryngeal Mask Airway by Unskilled Personnel in Children

The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2010 by Seoul National University Bundang Hospital.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Seoul National University Bundang Hospital
ClinicalTrials.gov Identifier:
NCT01191619
First received: August 5, 2010
Last updated: August 30, 2010
Last verified: July 2010
  Purpose

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.


Condition Intervention
Airway Management
Procedure: McIvor retractor

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Official Title: Comparison of Two Insertion Techniques of Proseal Laryngeal Mask Airway by Unskilled Personnel in Children

Resource links provided by NLM:


Further study details as provided by Seoul National University Bundang Hospital:

Primary Outcome Measures:
  • the success rate of proseal laryngeal mask airway (PLMA) insertion [ Time Frame: at the time of insertion of PLMA ] [ Designated as safety issue: No ]
    immediately after the insertion of PLMA


Secondary Outcome Measures:
  • the incidence of complications following PLMA insertion [ Time Frame: after the removal of PLMA, and 1 day after surgery ] [ Designated as safety issue: No ]
    blood staining: after the removal of PLMA; sore throat: 1 day after surgery


Estimated Enrollment: 134
Study Start Date: July 2010
Estimated Study Completion Date: December 2010
Estimated Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: McIvor group
groups in which proseal laryngeal mask airway is inserted with McIvor retractor.
Procedure: McIvor retractor
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.
Other Name: McIvor group

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.

  Eligibility

Ages Eligible for Study:   3 Years to 9 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • healthy pediatric patients undergoing surgery under general anesthesia

Exclusion Criteria:

  • pediatric patients with a known or predicted difficult airway, recent sore throat, mouth opening less than 2.5 cm, or at risk of aspiration
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01191619

Contacts
Contact: Jin-Young Hwang, MD 82-16-746-4750 mistyblue15@naver.com

Locations
Korea, Republic of
Seoul National University Bundang Hospital Recruiting
Gyeonggi-do, Korea, Republic of, 463-707
Contact: Jin-Young Hwang, MD    82-16-746-4750    mistyblue15@naver.com   
Principal Investigator: Jin-Young Hwang, MD         
Sponsors and Collaborators
Seoul National University Bundang Hospital
Investigators
Principal Investigator: Jin-Young Hwang, MD Fellow
  More Information

No publications provided by Seoul National University Bundang Hospital

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Seoul National University Bundang Hospital
ClinicalTrials.gov Identifier: NCT01191619     History of Changes
Other Study ID Numbers: B1006/104-004
Study First Received: August 5, 2010
Last Updated: August 30, 2010
Health Authority: Korea: Institutional Review Board

Keywords provided by Seoul National University Bundang Hospital:
McIvor retractor
Proseal laryngeal mask airway

ClinicalTrials.gov processed this record on September 18, 2014