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Completed

NCT Number: NCT00966186

The Rotational Insertion Technique for ProSeal Laryngeal Mask Airway

The purpose of this study is to compare two insertion techniques of large size ProSeal laryngeal mask airway. We hypothesized that insertion of ProSeal laryngeal mask airway with 90-degree rotation would reduce the contact surface between the device and pharyngeal wall and make it easy to advance the device over the smooth angle against the posterior pharyngeal wall.We compared the success rate and incidence of complication of the standard technique with the rotational technique.

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Key information

Conditions

General Anesthesia Elective Surgery Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications

Age range

27 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Seoul National University Bundang Hospital

Seongnam-si, Gyeonggi-do, South Korea

About this study

ProSeal laryngeal mask airway is not easy to be inserted due to its larger cuff especially in Asian population. First-time insertion success rate was lower and more time was required to achieve an effective airway even in well-trained physician. A number of techniques have been described to improve the insertion success rate. However, these techniques are only recommended to be used as backup when the digital or introducer tool techniques fail. We hypothesized that insertion of ProSeal laryngeal mask airway with 90-degree rotation would reduce the contact surface between the device and pharyngeal wall and make it easy to advance the device over the smooth angle against the posterior pharyngeal wall.We compared the success rate and incidence of complication of the standard technique with the rotational technique.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • American Society of Anesthesiologists physical status I-II

Exclusion criteria

  • Predicted difficult airway
  • Mouth opening less than 2.5 cm
  • Present sore throat
  • High risk of aspiration

Treatment and study plan

Insertion fo ProSeal laryngeal mask airway

Procedure

Insertion fo ProSeal laryngeal mask airway using each of Standard technique or Rotational technique

Primary outcomes

  1. Success of Insertion at First Attempt

    Time frame: 5 minute

Secondary outcomes

  1. Insertion Time, Sealing Pressure and Complication

    Time frame: 5 min - 4 hours

Sponsors and collaborators

Lead sponsor

Seoul National University Hospital

Other

Registry information

Official study title

The 90-degree Rotational Insertion Technique for the Large Size ProSeal Laryngeal Mask Airway

Important dates

Study start
2008
Primary completion
2009
Study completion
2009
First posted
Aug 26, 2009
Registry last updated
Aug 16, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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