NCT03984032

Brief Summary

Comparison of clinical performance between LMA Protector Cuff Pilot and LMA Supreme in terms of oropharyngeal leak pressure, time to insertion, ease of gastric tube insertion, laryngeal view, incidence of sore throat

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jul 2018

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 17, 2018

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 19, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 19, 2019

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

May 16, 2019

Completed
27 days until next milestone

First Posted

Study publicly available on registry

June 12, 2019

Completed
Last Updated

June 12, 2019

Status Verified

June 1, 2019

Enrollment Period

7 months

First QC Date

May 16, 2019

Last Update Submit

June 9, 2019

Conditions

Anesthesia

Keywords

LMA Protector Cuff PilotLMA SupremeClinical Performance

Outcome Measures

Primary Outcomes (1)

  • Oropharyngeal leak pressure (OLP)

    To assess the OLP of LMA Protector Cuff Pilot and LMA Supreme

    During induction of anaesthesia

Secondary Outcomes (4)

  • Mean time to insertion

    During induction of anaesthesia

  • Gastric tube insertion

    After induction of anaesthesia

  • Laryngeal view

    After induction of anaesthesia

  • Complications

    24 hours

Study Arms (2)

LMA Protector Cuff Pilot

EXPERIMENTAL
Device: LMA Supreme

LMA Supreme

ACTIVE COMPARATOR
Device: LMA Protector Cuff Pilot

Interventions

LMA Protector Cuff PilotDEVICE

Assessing the clinical performance of LMA Protector Cuff Pilot

LMA Supreme
LMA SupremeDEVICE

Assessing the clinical performance of LMA Supreme

LMA Protector Cuff Pilot

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients planned for general anaesthesia without muscle relaxant usage via supraglottic airway device.

You may not qualify if:

  • BMI \> 35
  • Patients with likelihood of difficult intubation (Simplified Airway Risk Index Score of 4 or more)
  • Patients with increased risks of aspirations (gastrooesophageal reflux disease, obstetric patients, hiatus hernia)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Universiti Kebangsaan Malaysia Medical Centre

Kuala Lumpur, Kuala Lumpur, 56000, Malaysia

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Consultant Anaesthesiologist

Study Record Dates

First Submitted

May 16, 2019

First Posted

June 12, 2019

Study Start

July 17, 2018

Primary Completion

February 19, 2019

Study Completion

February 19, 2019

Last Updated

June 12, 2019

Record last verified: 2019-06

Locations

MY(1)