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

NCT ID: NCT02058030

Last Updated: 2015-08-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-11-30
• Study Completion Date: 2014-12-31

Brief Summary

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.

Detailed Description

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.

Conditions

Anesthesia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Blinding Strategy: SINGLE

Study Groups

3cm head elevation

Insertion of ProSeal laryngeal mask airway

Group Type: OTHER

Insertion of ProSeal laryngeal mask airway

Intervention Type: 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

6cm head elevation

Insertion of ProSeal laryngeal mask airway

Group Type: ACTIVE_COMPARATOR

Insertion of ProSeal laryngeal mask airway

Intervention Type: 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

Interventions

Insertion of ProSeal laryngeal mask airway

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

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

National Medical Center, Seoul

OTHER

Sponsor Role: lead

Responsible Party

Sung Hoon Kim

MD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Mija Yun, MD, PhD

Role: STUDY_CHAIR

National medical center

Locations

National Medical Center

Seoul, Seoul, South Korea

Countries

South Korea

References

Yun MJ, Hwang JW, Kim SH, Hong HJ, Jeon YT, Park HP. Head elevation by 3 vs. 6 cm in ProSeal laryngeal mask airway insertion: a randomized controlled trial. BMC Anesthesiol. 2016 Aug 5;16(1):57. doi: 10.1186/s12871-016-0220-3.

Reference Type: DERIVED

PMID: 27494933 (View on PubMed)

Other Identifiers

phdkim1

Identifier Type: -

Identifier Source: org_study_id