Trial Outcomes & Findings for Comparison of Clinical Performance of the Guardian Laryngeal Mask With LMA Proseal (NCT NCT02063516)

NCT ID: NCT02063516

Last Updated: 2015-01-26

Results Overview

This will be measured over the full range of cuff volumes (0-40 ml) and at an intracuff pressure of 60 cm H2O.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 80 participants
• Primary outcome timeframe: 5 min
• Results posted on: 2015-01-26

Participant Flow

Participant milestones

Measure	Guardian Device: Guardian Laryngeal Mask Guardian Laryngeal Mask: Guardian Laryngeal Mask: The Guardian Laryngeal Mask (Ultimate Medical Pty Ltd, Richmond, Vic, Australia) is a new silicone-based single-use extraglottic airway device that forms a seal with the glottis for ventilation and with the hypopharynx for airway protection, and provides a gastric drainage port. In addition, it has a port for suctioning material from the hypopharynx and a pilot balloon valve that constantly monitors intracuff pressure. In the following randomized, non-crossover study, the investigators test if oropharyngeal leak pressures differed between the Guardian Laryngeal Mask and the LMA proseal in paralysed, anaesthetised patients.	Proseal Device:Proseal Laryngeal Mask Airway Proseal Laryngeal Mask Airway: Proseal Laryngeal Mask Airway: Silicon based, reusable, modified dorsal cuff and drainage tube
Overall Study STARTED	40	40
Overall Study COMPLETED	40	40
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Comparison of Clinical Performance of the Guardian Laryngeal Mask With LMA Proseal

Baseline characteristics by cohort

Measure	Guardian n=40 Participants Device: Guardian Laryngeal Mask Guardian Laryngeal Mask: Guardian Laryngeal Mask: The Guardian Laryngeal Mask (Ultimate Medical Pty Ltd, Richmond, Vic, Australia) is a new silicone-based single-use extraglottic airway device that forms a seal with the glottis for ventilation and with the hypopharynx for airway protection, and provides a gastric drainage port. In addition, it has a port for suctioning material from the hypopharynx and a pilot balloon valve that constantly monitors intracuff pressure. In the following randomized, non-crossover study, the investigators test if oropharyngeal leak pressures differed between the Guardian Laryngeal Mask and the LMA proseal in paralysed, anaesthetised patients.	Proseal n=40 Participants Device:Proseal Laryngeal Mask Airway Proseal Laryngeal Mask Airway: Proseal Laryngeal Mask Airway: Silicon based, reusable, modified dorsal cuff and drainage tube	Total n=80 Participants Total of all reporting groups
Age, Continuous	45.75 years STANDARD_DEVIATION 13.58 • n=5 Participants	45.20 years STANDARD_DEVIATION 14.78 • n=7 Participants	45.47 years STANDARD_DEVIATION 14.01 • n=5 Participants
Sex: Female, Male Female	28 Participants n=5 Participants	8 Participants n=7 Participants	36 Participants n=5 Participants
Sex: Female, Male Male	12 Participants n=5 Participants	32 Participants n=7 Participants	44 Participants n=5 Participants
Weight	61.65 kilogram STANDARD_DEVIATION 8.95 • n=5 Participants	59.75 kilogram STANDARD_DEVIATION 4.72 • n=7 Participants	60.70 kilogram STANDARD_DEVIATION 7.12 • n=5 Participants
Height	162.20 cm STANDARD_DEVIATION 4.86 • n=5 Participants	160.30 cm STANDARD_DEVIATION 4.11 • n=7 Participants	161.22 cm STANDARD_DEVIATION 4.54 • n=5 Participants
BMI	23.38 kg/m^2 STANDARD_DEVIATION 2.71 • n=5 Participants	23.27 kg/m^2 STANDARD_DEVIATION 1.85 • n=7 Participants	23.32 kg/m^2 STANDARD_DEVIATION 2.29 • n=5 Participants
Type of surgery Gynecology	18 participants n=5 Participants	20 participants n=7 Participants	38 participants n=5 Participants
Type of surgery Orthopedic	10 participants n=5 Participants	8 participants n=7 Participants	18 participants n=5 Participants
Type of surgery Urology	6 participants n=5 Participants	8 participants n=7 Participants	14 participants n=5 Participants
Type of surgery General Surgery	6 participants n=5 Participants	4 participants n=7 Participants	10 participants n=5 Participants

PRIMARY outcome

Timeframe: 5 min

This will be measured over the full range of cuff volumes (0-40 ml) and at an intracuff pressure of 60 cm H2O.

Outcome measures

Measure	Guardian n=40 Participants Device: Guardian Laryngeal Mask Guardian Laryngeal Mask: Guardian Laryngeal Mask: The Guardian Laryngeal Mask (Ultimate Medical Pty Ltd, Richmond, Vic, Australia) is a new silicone-based single-use extraglottic airway device that forms a seal with the glottis for ventilation and with the hypopharynx for airway protection, and provides a gastric drainage port. In addition, it has a port for suctioning material from the hypopharynx and a pilot balloon valve that constantly monitors intracuff pressure. In the following randomized, non-crossover study, the investigators test if oropharyngeal leak pressures differed between the Guardian Laryngeal Mask and the LMA proseal in paralysed, anaesthetised patients.	Proseal n=40 Participants Device:Proseal Laryngeal Mask Airway Proseal Laryngeal Mask Airway: Proseal Laryngeal Mask Airway: Silicon based, reusable, modified dorsal cuff and drainage tube
Oropharyngeal Seal Pressure	32.36 cmH2O Standard Deviation 4.93	29.41 cmH2O Standard Deviation 4.33

SECONDARY outcome

Timeframe: 5 min

Population: Fiber-optic scoring system: "1, clear view of vocal cord" "2, Only arytenoids visible" "3, Only epiglottis visible" "4, No laryngeal structures visible"

This will be determined fiberscopically via the airway tube over the full range of cuff volumes and at an intracuff pressure of 60 cm H2O.

Outcome measures

Measure	Guardian n=40 Participants Device: Guardian Laryngeal Mask Guardian Laryngeal Mask: Guardian Laryngeal Mask: The Guardian Laryngeal Mask (Ultimate Medical Pty Ltd, Richmond, Vic, Australia) is a new silicone-based single-use extraglottic airway device that forms a seal with the glottis for ventilation and with the hypopharynx for airway protection, and provides a gastric drainage port. In addition, it has a port for suctioning material from the hypopharynx and a pilot balloon valve that constantly monitors intracuff pressure. In the following randomized, non-crossover study, the investigators test if oropharyngeal leak pressures differed between the Guardian Laryngeal Mask and the LMA proseal in paralysed, anaesthetised patients.	Proseal n=40 Participants Device:Proseal Laryngeal Mask Airway Proseal Laryngeal Mask Airway: Proseal Laryngeal Mask Airway: Silicon based, reusable, modified dorsal cuff and drainage tube
Anatomic Position 1	17 participants	14 participants
Anatomic Position 2	20 participants	21 participants
Anatomic Position 3	2 participants	3 participants
Anatomic Position 4	1 participants	2 participants

OTHER_PRE_SPECIFIED outcome

Timeframe: 30 minutes, 60 minutes, 90 minutes and 120 minutes

The accuracy of the intrinsic cuff pressure indicator is assessed by documenting which colour band the indicator is displaying when inflated according to manufacturers instructions, and measuring the numeric cuff pressure at the same time with a standard analogue cuff pressure gauge. The manufacturer has documented what pressure range is meant to be indicated by each of three colour ranges.

Outcome measures

Measure	Guardian n=40 Participants Device: Guardian Laryngeal Mask Guardian Laryngeal Mask: Guardian Laryngeal Mask: The Guardian Laryngeal Mask (Ultimate Medical Pty Ltd, Richmond, Vic, Australia) is a new silicone-based single-use extraglottic airway device that forms a seal with the glottis for ventilation and with the hypopharynx for airway protection, and provides a gastric drainage port. In addition, it has a port for suctioning material from the hypopharynx and a pilot balloon valve that constantly monitors intracuff pressure. In the following randomized, non-crossover study, the investigators test if oropharyngeal leak pressures differed between the Guardian Laryngeal Mask and the LMA proseal in paralysed, anaesthetised patients.	Proseal n=40 Participants Device:Proseal Laryngeal Mask Airway Proseal Laryngeal Mask Airway: Proseal Laryngeal Mask Airway: Silicon based, reusable, modified dorsal cuff and drainage tube
Amount of Air Added to Keep Cuff Pressure 60cmH20. 30 min	1.34 ml Standard Deviation 0.40	0.84 ml Standard Deviation 0.15
Amount of Air Added to Keep Cuff Pressure 60cmH20. 60 min	1.24 ml Standard Deviation 0.30	0.86 ml Standard Deviation 0.16
Amount of Air Added to Keep Cuff Pressure 60cmH20. 90 min	1.34 ml Standard Deviation 0.40	0.88 ml Standard Deviation 0.17
Amount of Air Added to Keep Cuff Pressure 60cmH20. 120 min	1.46 ml Standard Deviation 0.44	0.96 ml Standard Deviation 0.18

Adverse Events

Guardian

Serious events: 0 serious events

Other events: 10 other events

Deaths: 0 deaths

Proseal

Serious events: 0 serious events

Other events: 12 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Guardian n=40 participants at risk Device: Guardian Laryngeal Mask Guardian Laryngeal Mask: Guardian Laryngeal Mask: The Guardian Laryngeal Mask (Ultimate Medical Pty Ltd, Richmond, Vic, Australia) is a new silicone-based single-use extraglottic airway device that forms a seal with the glottis for ventilation and with the hypopharynx for airway protection, and provides a gastric drainage port. In addition, it has a port for suctioning material from the hypopharynx and a pilot balloon valve that constantly monitors intracuff pressure. In the following randomized, non-crossover study, the investigators test if oropharyngeal leak pressures differed between the Guardian Laryngeal Mask and the LMA proseal in paralysed, anaesthetised patients.	Proseal n=40 participants at risk Device:Proseal Laryngeal Mask Airway Proseal Laryngeal Mask Airway: Proseal Laryngeal Mask Airway: Silicon based, reusable, modified dorsal cuff and drainage tube
Injury, poisoning and procedural complications Sore throat	15.0% 6/40 • 1, 2 and 24 hours after the end of surgery The patients were asked 1, 2, and 24 hours after the end of surgery to assess post -operative complication. Sore throat was defined as " constant pain or discomfort in the throat independent of swallowing" ; dysphagia was defined as "difficulty or pain provoked by swallowing" ; dysphonia was defined as "difficulty or pain on speaking".	17.5% 7/40 • 1, 2 and 24 hours after the end of surgery The patients were asked 1, 2, and 24 hours after the end of surgery to assess post -operative complication. Sore throat was defined as " constant pain or discomfort in the throat independent of swallowing" ; dysphagia was defined as "difficulty or pain provoked by swallowing" ; dysphonia was defined as "difficulty or pain on speaking".
Injury, poisoning and procedural complications Dysphagia	10.0% 4/40 • 1, 2 and 24 hours after the end of surgery The patients were asked 1, 2, and 24 hours after the end of surgery to assess post -operative complication. Sore throat was defined as " constant pain or discomfort in the throat independent of swallowing" ; dysphagia was defined as "difficulty or pain provoked by swallowing" ; dysphonia was defined as "difficulty or pain on speaking".	12.5% 5/40 • 1, 2 and 24 hours after the end of surgery The patients were asked 1, 2, and 24 hours after the end of surgery to assess post -operative complication. Sore throat was defined as " constant pain or discomfort in the throat independent of swallowing" ; dysphagia was defined as "difficulty or pain provoked by swallowing" ; dysphonia was defined as "difficulty or pain on speaking".

Additional Information

Dr. Haiyun Wang

tianjinMUGH

Phone: 008613752211206

Email: wanghy819@hotmail.com

Results disclosure agreements

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