Clinical trial NCT02058030: The Influence of Degree of Head Elevation on Insertion Success for ProSeal Laryngeal Mask Airway Insertion
Official 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Anesthesia
Keywords: ProSeal laryngeal mask airway
Insertion success
complication
Lead sponsor: National Medical Center, Seoul
Sponsor class: OTHER
First posted: 2014-02-07
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL

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.

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

Primary outcomes:
measure: insertion success rate
timeFrame: 2013.11 - 2014.12
Secondary outcomes:
measure: complication
timeFrame: 2013.11- 2014.12
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: National Medical Center
Study officials:
affiliation: National medical center
name: Mija Yun, MD, PhD
role: STUDY_CHAIR
References:
citation: 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.