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To compare insertion characteristics of 2 different supraglottic devices (Guardian LMA and Proseal LMA) and to observe any associated complications.
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)
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Guardian | Experimental | Device: Guardian Laryngeal Mask |
|
| Proseal | Experimental | Device:Proseal Laryngeal Mask Airway |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Guardian Laryngeal Mask | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 5 min |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 5 min |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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)
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Tianjin Medical University General Hospital | Tianjin | Tianjin Municipality | 300052 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25929558 | Derived | Pajiyar AK, Wen Z, Wang H, Ma L, Miao L, Wang G. Comparisons of clinical performance of Guardian laryngeal mask with laryngeal mask airway ProSeal. BMC Anesthesiol. 2015 May 1;15:69. doi: 10.1186/s12871-015-0039-3. |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | Proseal | Device:Proseal Laryngeal Mask Airway Proseal Laryngeal Mask Airway: Proseal Laryngeal Mask Airway: Silicon based, reusable, modified dorsal cuff and drainage tube |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Age group include age >18-<65 years |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Posted | Mean | Standard Deviation | cmH2O | 5 min |
|
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".
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Sore throat | Injury, poisoning and procedural complications | sore throat | Non-systematic Assessment | Sore throat was defined as " constant pain or discomfort in the throat independent of swallowing" |
We only use size-4 devices in adult patients with neuromuscular blockade, we presumed that same results would be obtained in patients who have not received neuromuscular blockade. lastly our data was not blinded causing potential source of bias.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Haiyun Wang | tianjinMUGH | 008613752211206 | wanghy819@hotmail.com |
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|
| Proseal Laryngeal Mask Airway | Device | Proseal Laryngeal Mask Airway: Silicon based, reusable, modified dorsal cuff and drainage tube |
|
| 30 minutes, 60 minutes, 90 minutes and 120 minutes |
| BG001 | Proseal | Device:Proseal Laryngeal Mask Airway Proseal Laryngeal Mask Airway: Proseal Laryngeal Mask Airway: Silicon based, reusable, modified dorsal cuff and drainage tube |
| BG002 | Total | Total of all reporting groups |
| Mean |
| Standard Deviation |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Weight | Mean | Standard Deviation | kilogram |
|
| Height | Mean | Standard Deviation | cm |
|
| BMI | Mean | Standard Deviation | kg/m^2 |
|
| Type of surgery | Number | participants |
|
| OG001 | Proseal | Device:Proseal Laryngeal Mask Airway Proseal Laryngeal Mask Airway: Proseal Laryngeal Mask Airway: Silicon based, reusable, modified dorsal cuff and drainage tube |
|
|
|
| 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. | Fiber-optic scoring system: "1, clear view of vocal cord" "2, Only arytenoids visible" "3, Only epiglottis visible" "4, No laryngeal structures visible" | Posted | Number | participants | 5 min |
|
|
|
|
| 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. | Posted | Mean | Standard Deviation | ml | 30 minutes, 60 minutes, 90 minutes and 120 minutes |
|
|
|
|
| 0 |
| 40 |
| 10 |
| 40 |
| EG001 | Proseal | Device:Proseal Laryngeal Mask Airway Proseal Laryngeal Mask Airway: Proseal Laryngeal Mask Airway: Silicon based, reusable, modified dorsal cuff and drainage tube | 0 | 40 | 12 | 40 |
|
| Dysphagia | Injury, poisoning and procedural complications | Dysphagia | Non-systematic Assessment | difficulty or pain provoked by swallowing |
|
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| 3 |
|
| 4 |
|
| 90 min |
|
| 120 min |
|
| t-test, 2 sided |
| 0.003 |
| 2-Sided |
| No |
| Superiority or Other |
| Amount of air added at 90 minutes to maintain cuff pressure 60cmH2O | t-test, 2 sided | 0.0042 | 2-Sided | No | Superiority or Other |
| Amount of air added at 120 minutes to maintain cuff pressure 60cmH2O | t-test, 2 sided | 0.004 | 2-Sided | No | Superiority or Other |