Efficacy of Oropharyngeal Seal Pressure
Conditions
Keywords
Airway Cuff, Guardian, Proseal, Cuff Pressure, laryngeal Mask Airway
Brief summary
To compare insertion characteristics of 2 different supraglottic devices (Guardian LMA and Proseal LMA) and to observe any associated complications.
Detailed description
Condition: The study focuses on the comparison of the ease of insertion, oropharyngeal leak pressure, fiberoptic position and ease of gastric tube placement between the Guardian LMA and the LMA Proseal in paralyzed, anesthetized patients. Device: Guardian Laryngeal Mask Device: LMA Proseal Study Type: Interventional Study Design: Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Subject)
Interventions
DEVICEGuardian 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 Laryngeal Mask Airway: Silicon based, reusable, modified dorsal cuff and drainage tube
Sponsors
Tianjin Medical University General Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
• Ambulatory patients scheduled to undergo knee arthroscopy, transurethral resection of bladder tumor, hand, gynecological and general surgical under a short general paralysed anesthesia of less than 2 hours (American Society of Anesthesiologists physical status I-II) * 18 to 65 years of age * Mallampati score less than 3 * thyromental distance more than 6.5 cm * mouth opening more than \>2.5 cm * a body mass index less than 35 kg/m2;
Exclusion criteria
* Body weight 50 Kg * Pregnancy * Difficult airway * Recent history of upper respiratory tract infection and sore throats * A history of esophageal reflux disease * ENT surgery * Laparoscopic surgery * Inability to understand the Study Information Sheet and provide a written consent to take part in the study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Oropharyngeal Seal Pressure | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Anatomic Position | 5 min | 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. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Amount of Air Added to Keep Cuff Pressure 60cmH20. | 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. |
Countries
China
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 40 |
| Proseal Device:Proseal Laryngeal Mask Airway
Proseal Laryngeal Mask Airway: Proseal Laryngeal Mask Airway: Silicon based, reusable, modified dorsal cuff and drainage tube | 40 |
| Total | 80 |
Baseline characteristics
| Characteristic | Guardian | Proseal | Total |
|---|---|---|---|
| Age, Continuous | 45.75 years STANDARD_DEVIATION 13.58 | 45.20 years STANDARD_DEVIATION 14.78 | 45.47 years STANDARD_DEVIATION 14.01 |
| BMI | 23.38 kg/m^2 STANDARD_DEVIATION 2.71 | 23.27 kg/m^2 STANDARD_DEVIATION 1.85 | 23.32 kg/m^2 STANDARD_DEVIATION 2.29 |
| Height | 162.20 cm STANDARD_DEVIATION 4.86 | 160.30 cm STANDARD_DEVIATION 4.11 | 161.22 cm STANDARD_DEVIATION 4.54 |
| Sex: Female, Male Female | 28 Participants | 8 Participants | 36 Participants |
| Sex: Female, Male Male | 12 Participants | 32 Participants | 44 Participants |
| Type of surgery General Surgery | 6 participants | 4 participants | 10 participants |
| Type of surgery Gynecology | 18 participants | 20 participants | 38 participants |
| Type of surgery Orthopedic | 10 participants | 8 participants | 18 participants |
| Type of surgery Urology | 6 participants | 8 participants | 14 participants |
| Weight | 61.65 kilogram STANDARD_DEVIATION 8.95 | 59.75 kilogram STANDARD_DEVIATION 4.72 | 60.70 kilogram STANDARD_DEVIATION 7.12 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 10 / 40 | 12 / 40 |
| serious Total, serious adverse events | 0 / 40 | 0 / 40 |
Outcome results
Primary
Oropharyngeal Seal Pressure
This will be measured over the full range of cuff volumes (0-40 ml) and at an intracuff pressure of 60 cm H2O.
Time frame: 5 min
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Guardian | Oropharyngeal Seal Pressure | 32.36 cmH2O | Standard Deviation 4.93 |
| Proseal | Oropharyngeal Seal Pressure | 29.41 cmH2O | Standard Deviation 4.33 |
Comparison: It was calculated that 80 adult patients randomized from different surgical department would have 80% power to detect a difference in 2 point in mean. Sampling size was determined using 2 sided t-test (alpha=0.05).p-value: 0.04t-test, 2 sided
Secondary
Anatomic Position
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.
Time frame: 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
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Guardian | Anatomic Position | 2 | 20 participants |
| Guardian | Anatomic Position | 1 | 17 participants |
| Guardian | Anatomic Position | 3 | 2 participants |
| Guardian | Anatomic Position | 4 | 1 participants |
| Proseal | Anatomic Position | 4 | 2 participants |
| Proseal | Anatomic Position | 3 | 3 participants |
| Proseal | Anatomic Position | 1 | 14 participants |
| Proseal | Anatomic Position | 2 | 21 participants |
p-value: 0.836Chi-squared
Other Pre-specified
Amount of Air Added to Keep Cuff Pressure 60cmH20.
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.
Time frame: 30 minutes, 60 minutes, 90 minutes and 120 minutes
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Guardian | Amount of Air Added to Keep Cuff Pressure 60cmH20. | 30 min | 1.34 ml | Standard Deviation 0.4 |
| Guardian | Amount of Air Added to Keep Cuff Pressure 60cmH20. | 60 min | 1.24 ml | Standard Deviation 0.3 |
| Guardian | Amount of Air Added to Keep Cuff Pressure 60cmH20. | 90 min | 1.34 ml | Standard Deviation 0.4 |
| Guardian | Amount of Air Added to Keep Cuff Pressure 60cmH20. | 120 min | 1.46 ml | Standard Deviation 0.44 |
| Proseal | Amount of Air Added to Keep Cuff Pressure 60cmH20. | 120 min | 0.96 ml | Standard Deviation 0.18 |
| Proseal | Amount of Air Added to Keep Cuff Pressure 60cmH20. | 30 min | 0.84 ml | Standard Deviation 0.15 |
| Proseal | Amount of Air Added to Keep Cuff Pressure 60cmH20. | 90 min | 0.88 ml | Standard Deviation 0.17 |
| Proseal | Amount of Air Added to Keep Cuff Pressure 60cmH20. | 60 min | 0.86 ml | Standard Deviation 0.16 |
Comparison: Amount of air added at 30 minutes to maintain cuff pressure 60cmH2Op-value: 0.0035t-test, 2 sided
Comparison: Amount of air added at 60 minutes to maintain cuff pressure 60cmH2Op-value: 0.003t-test, 2 sided
Comparison: Amount of air added at 90 minutes to maintain cuff pressure 60cmH2Op-value: 0.0042t-test, 2 sided
Comparison: Amount of air added at 120 minutes to maintain cuff pressure 60cmH2Op-value: 0.004t-test, 2 sided