NCT03664700: ADEPT1

Observational Study of the LMA Protector

Terminated Results posted Last updated 14 January 2025

What this trial tests

trial testing LMA Protector in Airway Complication of Anesthesia in 112 participants. Terminated before completion.

Timeline

5 November 2019

Primary endpoint
1 August 2021

1 August 2021

Quick facts

Lead sponsor	Oxford University Hospitals NHS Trust
Status	Terminated
Study type	OBSERVATIONAL
Enrollment	112
Start date	5 November 2019
Primary completion	1 August 2021
Estimated completion	1 August 2021
Sites	5 locations across United Kingdom

Drugs / interventions tested

• LMA Protector

Conditions studied

• Airway Complication of Anesthesia — all drugs for Airway Complication of Anesthesia →

Sponsor

Oxford University Hospitals NHS Trust

Who can join

18 and older, any sex, with Airway Complication of Anesthesia. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

First go Insertion Success Rate Primary · Day 1

Whether insertion during first go was successful or not

Group	Value	95% CI
LMA Protector	100

First go Successful Ventilation Rate Primary · Day 1

Whether ventilation during first go was successful or not

Group	Value	95% CI
LMA Protector	110

Number of Participants With Complication Free Insertions Primary · Day 1

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

Group	Value	95% CI
LMA Protector	72

Time to First Square Capnography Waveform Secondary · Day 1

Record time in seconds of time to first capnography trace

Group	Value	95% CI
LMA Protector	31	26 – 40

Lowest Oxygen Saturation Level Secondary · Day 1

Record of lowest oxygen saturation reading across all participants

Group	Value	95% CI
LMA Protector	91

Interventions Needed to Ensure Airway Patency Secondary · Day 1

Collect number of predefined interventions needed to keep airway patent

1 or more airway manipulation required

Group	Value	95% CI
LMA Protector	67

Manipulation: Jaw thrust

Group	Value	95% CI
LMA Protector	50

Manipulation: Neck extension

Group	Value	95% CI
LMA Protector	45

Manipulation: Chin lift

Group	Value	95% CI
LMA Protector	4

Manipulation: Reposition device

Group	Value	95% CI
LMA Protector	3

Number of Participants With Visible Chest Movement Secondary · Day 1

The success of ventilation will depend on whether there was visible chest movement

Group	Value	95% CI
LMA Protector	110

Number of Participants With Adequate Tidal Volume at Attempt of Ventilation Secondary · Day 1

The success of ventilation will depend on whether there was tidal volume \> 7ml/kg

Group	Value	95% CI
LMA Protector	110

Number of Participants With Stable Oxygen Saturations Secondary · Day 1

The success of ventilation will depend on whether there was stable SpO2

Group	Value	95% CI
LMA Protector	110

Number of Participants With Square Capnography Trace Secondary · Day 1

The success of ventilation will depend on whether there was square capnography trace

Group	Value	95% CI
LMA Protector	110

Complications Occurrence During Insertion of Device, During Anaesthesia, and on Device Removal Secondary · Day 1

Collect number of pre-defined complications of device usage

Number who experienced complications

Group	Value	95% CI
LMA Protector	39

Number who experienced complications immediately following device insertion

Group	Value	95% CI
LMA Protector	6

Number who experienced complications during maintenance of anaesthesia

Group	Value	95% CI
LMA Protector	1

Number who experienced complications upon extubation

Group	Value	95% CI
LMA Protector	32

Number who experienced mucosal injury

Group	Value	95% CI
LMA Protector	19

Number who experienced mild post-operative sore throat

Group	Value	95% CI
LMA Protector	37

Number who experienced mild pain on swallowing

Group	Value	95% CI
LMA Protector	12

Number who experienced mild post-operative dysphonia

Group	Value	95% CI
LMA Protector	7

Complications Occurrence During Insertion of Device, During Anaesthesia, and on Device Removal Secondary · Day 2

Collect number of pre-defined complications of device usage. Secondary complication where asked about on Day 2 to ensure patients had recovered from the effects of the anaesthetic and are able to report any complications.

Number who experienced complications

Group	Value	95% CI
LMA Protector	13

Vomiting

Group	Value	95% CI
LMA Protector	1

Sore throat

Group	Value	95% CI
LMA Protector	10

Pain on swallowing

Group	Value	95% CI
LMA Protector	1

Neck or mouth ache

Group	Value	95% CI
LMA Protector	1

Adverse events — posted to ClinicalTrials.gov

Time frame: 1 day. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

LMA Protector

Serious: 1/111 (1%)

Deaths: 0/111

Serious adverse events (1 terms)

Reaction	System	LMA Protector
Desaturation	Respiratory, thoracic and mediastinal disorders	—

Other adverse events (7 terms — click to expand)

Reaction	System	LMA Protector
Blood on device	Respiratory, thoracic and mediastinal disorders	—
Pain on swallowing	Injury, poisoning and procedural complications	—
hiccoughing	Respiratory, thoracic and mediastinal disorders	—
Poor seal	Respiratory, thoracic and mediastinal disorders	—
Repositioning of device	Respiratory, thoracic and mediastinal disorders	—
Tongue numbness	Injury, poisoning and procedural complications	—
Jaw pain	Injury, poisoning and procedural complications	—

Most-reported serious reactions: Desaturation.

Data from ClinicalTrials.gov NCT03664700 adverse events section.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Assessing a novel second generation laryngeal mask airway using the 'ADEPT' approach: results from the LMA® Protector™ observational study.
   Ní Eochagáin A, Athanassoglou V, Cumberworth A, Morris O, et al · · 2023 · cited 7× · PMID 36063277 · DOI 10.1007/s10877-022-00910-5