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

NCT01191619 | Unknown DMC

• 1 other identifier: B1006/104-004
• Study Type: interventional
• Target: 134
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Airway Management

Keywords

McIvor retractor; Proseal laryngeal mask airway

Outcome Measures

Primary Outcomes (1)

• the success rate of proseal laryngeal mask airway (PLMA) insertion

  immediately after the insertion of PLMA

  at the time of insertion of PLMA

Secondary Outcomes (1)

• the incidence of complications following PLMA insertion

  after the removal of PLMA, and 1 day after surgery

Study Arms (1)

McIvor group

EXPERIMENTAL

groups in which proseal laryngeal mask airway is inserted with McIvor retractor.

Procedure: McIvor retractor

Interventions

McIvor retractor PROCEDURE

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.

Also known as: McIvor group

McIvor group

Eligibility Criteria

• Age: 3 Years - 9 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• healthy pediatric patients undergoing surgery under general anesthesia

You may not qualify if:

• pediatric patients with a known or predicted difficult airway, recent sore throat, mouth opening less than 2.5 cm, or at risk of aspiration

Sponsors & Collaborators

• Seoul National University Bundang Hospital: lead

Study Sites (1)

Seoul National University Bundang Hospital

Gyeonggi-do, 463-707, South Korea

RECRUITING

Related Publications (1)

• 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.

  PMID: 21691935 DERIVED

Study Officials

• Jin-Young Hwang, MD

  Fellow

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jin-Young Hwang, MD

CONTACT

82-16-746-4750; mistyblue15@naver.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: August 5, 2010
• First Posted: August 31, 2010
• Study Start: July 1, 2010
• Primary Completion: December 1, 2010
• Study Completion: December 1, 2010
• Last Updated: August 31, 2010

Record last verified: 2010-07

Locations

KR (1)