NCT03664700

Brief Summary

The investigators want to investigate the user friendliness, and performance of the LMA Protector. The principal research question is to assess the overall performance of the LMA Protector. The investigators are merely making observations related to use of the device during clinical practice.

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
112

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Nov 2019

Geographic Reach
1 country

5 active sites

Status
terminated

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

First Submitted

Initial submission to the registry

July 26, 2018

Completed
2 months until next milestone

First Posted

Study publicly available on registry

September 10, 2018

Completed
1.2 years until next milestone

Study Start

First participant enrolled

November 5, 2019

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2021

Completed
3.5 years until next milestone

Results Posted

Study results publicly available

January 14, 2025

Completed
Last Updated

January 14, 2025

Status Verified

January 1, 2025

Enrollment Period

1.7 years

First QC Date

July 26, 2018

Results QC Date

November 30, 2022

Last Update Submit

January 10, 2025

Conditions

Airway Complication of Anesthesia

Keywords

Supraglottic airway deviceLMA Protector

Outcome Measures

Primary Outcomes (3)

  • First go Insertion Success Rate

    Whether insertion during first go was successful or not

    Day 1

  • First go Successful Ventilation Rate

    Whether ventilation during first go was successful or not

    Day 1

  • Number of Participants With Complication Free Insertions

    Number of participants with complication free insertions divided by total number of participants

    Day 1

Secondary Outcomes (9)

  • Time to First Square Capnography Waveform

    Day 1

  • Lowest Oxygen Saturation Level

    Day 1

  • Interventions Needed to Ensure Airway Patency

    Day 1

  • Number of Participants With Visible Chest Movement

    Day 1

  • Number of Participants With Adequate Tidal Volume at Attempt of Ventilation

    Day 1

  • +4 more secondary outcomes

Study Arms (1)

LMA Protector

The LMA Protector will be used

Device: LMA Protector

Interventions

LMA ProtectorDEVICE

The LMA Protector will be inserted when a supraglottic device is needed

LMA Protector

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients undergoing operation under general anaesthesia with a supraglottic airway device

You may qualify if:

  • Adult participants who are having a general anaesthetic.
  • Participant is willing and able to give informed consent for participation in the study.
  • Male or Female, aged 18 years or above.
  • ASA 1 - 3 category patients
  • Elective operations
  • Urgent operations
  • Patients suitable for an SAD based on patient and operation factors.

You may not qualify if:

  • The participant may not enter the study if ANY of the following apply:
  • Refusal of consent
  • Age less than 18 years
  • Require intubation for the operation
  • Risk of regurgitation
  • ASA 4 and above
  • Mouth opening less than 2.5cm Require awake intubation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

Royal United Hospital

Bath, United Kingdom

Location

Aneurin Bevan University Health Board

Cardiff, United Kingdom

Location

Nothampton General Hospital

Northampton, United Kingdom

Location

Oxford University Hospitals

Oxford, United Kingdom

Location

Royal Berkshire Hospital

Reading, United Kingdom

Location

Results Point of Contact

Title
Dr Vassilis Athanassoglou
Organization
Oxford University Hospitals
vassilis.athanassoglou@ouh.nhs.uk
01865

Study Officials

  • Vassilis Athanassoglou

    Oxford University Hospitals NHS Trust

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Primary Investigator

Study Record Dates

First Submitted

July 26, 2018

First Posted

September 10, 2018

Study Start

November 5, 2019

Primary Completion

August 1, 2021

Study Completion

August 1, 2021

Last Updated

January 14, 2025

Results First Posted

January 14, 2025

Record last verified: 2025-01

Data Sharing

IPD Sharing
Will not share

Data will be collected prospectively on data collection sheets completed by the anaesthetist / investigator during anaesthesia. Each site will manage their own data set and the data will be pooled at the end of the recruitment phase across all sites. Data will be sent from sites to the lead study team only at the end of the data collection. Consent form and initial data collection forms will be filed in the master folder and kept locked in the dedicated research locker in the department. The PI at each site will have access to this log. Each site will assign a study ID for each participant and a record of these IDs will be kept in the site file. Only anonymised data will be sent from each trust to the main study team. No personal data will be sent to the coordinating centre.

Locations

GB(5)