NCT04338412

Brief Summary

Usage of LMA has gained much importance especially as a rescue device for failed intubation. We hypothesised optimal operating table height could improve successful attempt of ProSeal-LMA™ (P-LMA™) insertion. The main objective of this study is to evaluate the optimal operating table height for successful placement of P-LMA™ by comparing operating table height to operators' body landmark. The secondary objectives of this study are to evaluate duration required for a successful P-LMA™ insertion and its associated complications during the attempt.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
150

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jun 2019

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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

Study Start

First participant enrolled

June 1, 2019

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

April 6, 2020

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 8, 2020

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 31, 2021

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 31, 2021

Completed
Last Updated

April 8, 2020

Status Verified

April 1, 2020

Enrollment Period

1.7 years

First QC Date

April 6, 2020

Last Update Submit

April 6, 2020

Conditions

Evaluation of Optimal Operating Table Height for Successful Placement of Proseal Laryngeal Mask Airway

Keywords

Proseal LMATable heightLMA placementBody landmark

Outcome Measures

Primary Outcomes (1)

  • Optimal operating table height for successful placement of P-LMA™

    To evaluate optimal operating table height for successful placement of P-LMA™ by comparing operating table height to operators' body landmark

    2 years

Secondary Outcomes (2)

  • Evaluation of time required for a successful P-LMA™ insertion

    2 years

  • Evaluation of associated complications during P-LMA™ insertion

    2 years

Study Arms (3)

Group U

ACTIVE COMPARATOR

Performers' umbilicus

Device: ProSeal-LMA™

Group R

ACTIVE COMPARATOR

Performers' lowest rib margin

Device: ProSeal-LMA™

Group X

ACTIVE COMPARATOR

Performers' xiphoid process

Device: ProSeal-LMA™

Interventions

ProSeal-LMA™DEVICE

It is a second generation LMA that is commonly used among all other LMAs

Group RGroup UGroup X

Eligibility Criteria

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

You may qualify if:

  • Age between 18 to 65 years old
  • American Society of Anesthesiologists (ASA) I-II patients
  • Elective and emergency surgeries requiring general anaesthesia where use of P-LMA™ is not contraindicated

You may not qualify if:

  • Congenital or acquired airway abnormality
  • Cervical spine pathology
  • Edentulous or loose tooth
  • BMI ≥35 kg/m2

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Universiti Kebangsaan Malaysia Medical Centre

Kuala Lumpur, 56000, Malaysia

RECRUITING

Central Study Contacts

AZLINA MASDAR, MD UKM

CONTACT

+60391455555azlinamasdar@yahoo.com

SONG LIN LOW, MBBS

CONTACT

+60391455555songlin_87@hotmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
OTHER
Intervention Model
FACTORIAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr

Study Record Dates

First Submitted

April 6, 2020

First Posted

April 8, 2020

Study Start

June 1, 2019

Primary Completion

January 31, 2021

Study Completion

May 31, 2021

Last Updated

April 8, 2020

Record last verified: 2020-04

Locations

MY(1)