The Influence of Degree of Head Elevation on Insertion Success for ProSeal Laryngeal Mask Airway Insertion
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
1 other identifier
interventional
80
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Nov 2013
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 8, 2013
CompletedStudy Start
First participant enrolled
November 1, 2013
CompletedFirst Posted
Study publicly available on registry
February 7, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2014
CompletedAugust 7, 2015
August 1, 2015
1 year
October 8, 2013
August 5, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
insertion success rate
2013.11 - 2014.12
Secondary Outcomes (1)
complication
2013.11- 2014.12
Study Arms (2)
3cm head elevation
OTHERInsertion of ProSeal laryngeal mask airway
6cm head elevation
ACTIVE COMPARATORInsertion of ProSeal laryngeal mask airway
Interventions
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
Eligibility Criteria
You may qualify if:
- American Society of Anesthesiologists physical status 1-2
- scheduled for minor surgery in the supine position were enrolled
You may not qualify if:
- cardiorespiratory disease patients
- patients were at risk of aspiration
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
National Medical Center
Seoul, Seoul, 100-799, South Korea
Related Publications (1)
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.
PMID: 27494933DERIVED
Study Officials
- STUDY CHAIR
Mija Yun, MD, PhD
National medical center
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- MD
Study Record Dates
First Submitted
October 8, 2013
First Posted
February 7, 2014
Study Start
November 1, 2013
Primary Completion
November 1, 2014
Study Completion
December 1, 2014
Last Updated
August 7, 2015
Record last verified: 2015-08