Trial Outcomes & Findings for Observational Study of the LMA Protector (NCT NCT03664700)

NCT ID: NCT03664700

Last Updated: 2025-01-14

Results Overview

Whether insertion during first go was successful or not

• Recruitment status: TERMINATED
• Target enrollment: 112 participants
• Primary outcome timeframe: Day 1
• Results posted on: 2025-01-14

Participant Flow

Participant milestones

Measure	LMA Protector The LMA Protector will be used LMA Protector: The LMA Protector will be inserted when a supraglottic device is needed
Overall Study STARTED	112
Overall Study COMPLETED	111
Overall Study NOT COMPLETED	1

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Measure	LMA Protector n=111 Participants The LMA Protector will be used LMA Protector: The LMA Protector will be inserted when a supraglottic device is needed
Age, Continuous	68 years n=111 Participants
Sex: Female, Male Female	58 Participants n=111 Participants
Sex: Female, Male Male	53 Participants n=111 Participants
Region of Enrollment United Kingdom	50 Participants n=111 Participants
Region of Enrollment Ireland	61 Participants n=111 Participants

PRIMARY outcome

Timeframe: Day 1

Whether insertion during first go was successful or not

Outcome measures

Measure	LMA Protector n=111 Participants The LMA Protector will be used LMA Protector: The LMA Protector will be inserted when a supraglottic device is needed
First go Insertion Success Rate	100 Participants

PRIMARY outcome

Timeframe: Day 1

Whether ventilation during first go was successful or not

Outcome measures

Measure	LMA Protector n=111 Participants The LMA Protector will be used LMA Protector: The LMA Protector will be inserted when a supraglottic device is needed
First go Successful Ventilation Rate	110 Participants

PRIMARY outcome

Timeframe: Day 1

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

Outcome measures

Measure	LMA Protector n=111 Participants The LMA Protector will be used LMA Protector: The LMA Protector will be inserted when a supraglottic device is needed
Number of Participants With Complication Free Insertions	72 Participants

SECONDARY outcome

Timeframe: Day 1

Record time in seconds of time to first capnography trace

Outcome measures

Measure	LMA Protector n=111 Participants The LMA Protector will be used LMA Protector: The LMA Protector will be inserted when a supraglottic device is needed
Time to First Square Capnography Waveform	31 Seconds Interval 26.0 to 40.0

SECONDARY outcome

Timeframe: Day 1

Record of lowest oxygen saturation reading across all participants

Outcome measures

Measure	LMA Protector n=111 Participants The LMA Protector will be used LMA Protector: The LMA Protector will be inserted when a supraglottic device is needed
Lowest Oxygen Saturation Level	91 Percent of oxygen saturation

SECONDARY outcome

Timeframe: Day 1

Population: The number analysed in one or more rows relates to the number of participants for whom 1 or more airway manipulations was required.

Collect number of predefined interventions needed to keep airway patent

Outcome measures

Measure	LMA Protector n=111 Participants The LMA Protector will be used LMA Protector: The LMA Protector will be inserted when a supraglottic device is needed
Interventions Needed to Ensure Airway Patency 1 or more airway manipulation required	67 Participants
Interventions Needed to Ensure Airway Patency Manipulation: Jaw thrust	50 Participants
Interventions Needed to Ensure Airway Patency Manipulation: Neck extension	45 Participants
Interventions Needed to Ensure Airway Patency Manipulation: Chin lift	4 Participants
Interventions Needed to Ensure Airway Patency Manipulation: Reposition device	3 Participants

SECONDARY outcome

Timeframe: Day 1

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

Outcome measures

Measure	LMA Protector n=111 Participants The LMA Protector will be used LMA Protector: The LMA Protector will be inserted when a supraglottic device is needed
Number of Participants With Visible Chest Movement	110 Participants

SECONDARY outcome

Timeframe: Day 1

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

Outcome measures

Measure	LMA Protector n=111 Participants The LMA Protector will be used LMA Protector: The LMA Protector will be inserted when a supraglottic device is needed
Number of Participants With Adequate Tidal Volume at Attempt of Ventilation	110 Participants

SECONDARY outcome

Timeframe: Day 1

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

Outcome measures

Measure	LMA Protector n=111 Participants The LMA Protector will be used LMA Protector: The LMA Protector will be inserted when a supraglottic device is needed
Number of Participants With Stable Oxygen Saturations	110 Participants

SECONDARY outcome

Timeframe: Day 1

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

Outcome measures

Measure	LMA Protector n=111 Participants The LMA Protector will be used LMA Protector: The LMA Protector will be inserted when a supraglottic device is needed
Number of Participants With Square Capnography Trace	110 Participants

SECONDARY outcome

Timeframe: Day 1

Population: Further breakdown of when complications occurred and the pre-defined complications of device usage are presented for the number of participants who experienced complications.

Collect number of pre-defined complications of device usage

Outcome measures

Measure	LMA Protector n=111 Participants The LMA Protector will be used LMA Protector: The LMA Protector will be inserted when a supraglottic device is needed
Complications Occurrence During Insertion of Device, During Anaesthesia, and on Device Removal Number who experienced complications	39 Participants
Complications Occurrence During Insertion of Device, During Anaesthesia, and on Device Removal Number who experienced complications immediately following device insertion	6 Participants
Complications Occurrence During Insertion of Device, During Anaesthesia, and on Device Removal Number who experienced complications during maintenance of anaesthesia	1 Participants
Complications Occurrence During Insertion of Device, During Anaesthesia, and on Device Removal Number who experienced complications upon extubation	32 Participants
Complications Occurrence During Insertion of Device, During Anaesthesia, and on Device Removal Number who experienced mucosal injury	19 Participants
Complications Occurrence During Insertion of Device, During Anaesthesia, and on Device Removal Number who experienced mild post-operative sore throat	37 Participants
Complications Occurrence During Insertion of Device, During Anaesthesia, and on Device Removal Number who experienced mild pain on swallowing	12 Participants
Complications Occurrence During Insertion of Device, During Anaesthesia, and on Device Removal Number who experienced mild post-operative dysphonia	7 Participants
Complications Occurrence During Insertion of Device, During Anaesthesia, and on Device Removal Number who experienced mild mouth pain	3 Participants
Complications Occurrence During Insertion of Device, During Anaesthesia, and on Device Removal Number who experienced mild jaw pain	3 Participants
Complications Occurrence During Insertion of Device, During Anaesthesia, and on Device Removal Number who experienced mild numbness of tongue	1 Participants

SECONDARY outcome

Timeframe: Day 2

Population: Further breakdown of when complications occurred and the pre-defined complications of device usage are presented for the number of participants who experienced complications.

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.

Outcome measures

Measure	LMA Protector n=111 Participants The LMA Protector will be used LMA Protector: The LMA Protector will be inserted when a supraglottic device is needed
Complications Occurrence During Insertion of Device, During Anaesthesia, and on Device Removal Vomiting	1 Participants
Complications Occurrence During Insertion of Device, During Anaesthesia, and on Device Removal Number who experienced complications	13 Participants
Complications Occurrence During Insertion of Device, During Anaesthesia, and on Device Removal Sore throat	10 Participants
Complications Occurrence During Insertion of Device, During Anaesthesia, and on Device Removal Pain on swallowing	1 Participants
Complications Occurrence During Insertion of Device, During Anaesthesia, and on Device Removal Neck or mouth ache	1 Participants

Adverse Events

LMA Protector

Serious events: 1 serious events

Other events: 39 other events

Deaths: 0 deaths

Serious adverse events

Measure	LMA Protector n=111 participants at risk The LMA Protector will be used LMA Protector: The LMA Protector will be inserted when a supraglottic device is needed Major Complications (desaturation to 91%) 1; 0.9% Minor Complications 39, 35% * 6, 5.4% immediately following device insertion * 1, 0.9% during maintenance of anaesthesia * 32, 28.8% upon extubation
Respiratory, thoracic and mediastinal disorders Desaturation	0.90% 1/111 • Number of events 1 • 1 day Adverse events were collected upon removal of the device and upon questioning in the PACU.

Other adverse events

Measure	LMA Protector n=111 participants at risk The LMA Protector will be used LMA Protector: The LMA Protector will be inserted when a supraglottic device is needed Major Complications (desaturation to 91%) 1; 0.9% Minor Complications 39, 35% * 6, 5.4% immediately following device insertion * 1, 0.9% during maintenance of anaesthesia * 32, 28.8% upon extubation
Respiratory, thoracic and mediastinal disorders hiccoughing	2.7% 3/111 • Number of events 3 • 1 day Adverse events were collected upon removal of the device and upon questioning in the PACU.
Respiratory, thoracic and mediastinal disorders Poor seal	1.8% 2/111 • Number of events 2 • 1 day Adverse events were collected upon removal of the device and upon questioning in the PACU.
Respiratory, thoracic and mediastinal disorders Repositioning of device	0.90% 1/111 • Number of events 1 • 1 day Adverse events were collected upon removal of the device and upon questioning in the PACU.
Respiratory, thoracic and mediastinal disorders Blood on device	17.1% 19/111 • Number of events 19 • 1 day Adverse events were collected upon removal of the device and upon questioning in the PACU.
Injury, poisoning and procedural complications Pain on swallowing	10.8% 12/111 • Number of events 12 • 1 day Adverse events were collected upon removal of the device and upon questioning in the PACU.
Injury, poisoning and procedural complications Tongue numbness	0.90% 1/111 • Number of events 1 • 1 day Adverse events were collected upon removal of the device and upon questioning in the PACU.
Injury, poisoning and procedural complications Jaw pain	0.90% 1/111 • Number of events 1 • 1 day Adverse events were collected upon removal of the device and upon questioning in the PACU.

Additional Information

Dr Vassilis Athanassoglou

Oxford University Hospitals

Phone: 01865

Email: vassilis.athanassoglou@ouh.nhs.uk

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place