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Completed

NCT Number: NCT02058030

The Influence of Degree of Head Elevation on Insertion Success for ProSeal Laryngeal Mask Airway Insertion

Background - The purpose of the present study is to evaluate the success and pharyngeal trauma when 3 or 6 cm height of pillow is used for the ProSealTM laryngeal mask airway insertion

Methods

- This prospective randomized, controlled study included 80 adult patients . In the 3 cm (n=40) or 6 cm group (n=40), the PLMA was inserted while the head is placed on the 3 cm or 6 cm height of pillow. The success rate at first and second attempt, insertion time, blood staining on cuff, sore throat and hoarseness were assessed.

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Key information

Conditions

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

National Medical Center

Seoul, 100-799, South Korea

About this study

Background: The "sniffing position" (i.e., the neck flexed and head extended by means of a pillow) eases tracheal intubation because the three axes, namely, the axis of the mouth, the pharyngeal axis and the laryngeal axis, are put in almost a straight line. The benefit of the sniffing position that align three axis could possibly be applicable when the ProSeal LMA is inserted. For the endotracheal intubation, it has been recommended to elevate the patient's head 8 to 10 cm with pads under the occiput (shoulder remaining on the table) and extend the head at the atlanto-occipital joint to align the oral, pharyngeal, and laryngeal axes such that the passage and line of vision from the lips to the glottic opening are most nearly a straight line.

There have been several clinical studies about the effect of head and neck position including neutral, flexion or extension on the ease of LMA insertion.

However, it has not been much recommended or investigated about the influence of head elevation on the insertion success of PLMA until now. The purpose of the present study is to evaluate the success and pharyngeal trauma when 3 or 6 cm height of pillow is used for the ProSeal laryngeal mask airway insertion in adult patients.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • American Society of Anesthesiologists physical status 1-2
  • scheduled for minor surgery in the supine position were enrolled

Exclusion criteria

  • cardiorespiratory disease patients
  • patients were at risk of aspiration

Treatment and study plan

Insertion of ProSeal laryngeal mask airway

Device

The patient's head was placed on the 3 cm or 6 cm height of a pillow in supine and PLMA was inserted using a standard method in the sniffing position.

The success rate at first and second attempt, insertion time, Seal pressure, hemodynamic variables, complications(blood staining on cuff, sore throat and hoarseness) were assessed

Primary outcomes

  1. insertion success rate

    Time frame: 2013.11 - 2014.12

Secondary outcomes

  1. complication

    Time frame: 2013.11- 2014.12

    Number of participants with blood on the surface of the cuff, postoperative sore throat and hoarseness as indices of complications.

Sponsors and collaborators

Lead sponsor

National Medical Center, Seoul

Other

Registry information

Official study title

The 3 cm of Head Elevation Provides Higher Insertion Success Than do the 6 cm of it for ProSeal Laryngeal Mask Airway Insertion in Adult Patients

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
Feb 7, 2014
Registry last updated
Aug 7, 2015

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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